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Bone & Joint Open
Vol. 1, Issue 9 | Pages 556 - 561
14 Sep 2020
Clough TM Shah N Divecha H Talwalkar S

Aims. The exact risk to patients undergoing surgery who develop COVID-19 is not yet fully known. This study aims to provide the current data to allow adequate consent regarding the risks of post-surgery COVID-19 infection and subsequent COVID-19-related mortality. Methods. All orthopaedic trauma cases at the Wrightington Wigan and Leigh NHS Foundation Trust from ‘lockdown’ (23 March 2020) to date (15 June 2020) were collated and split into three groups. Adult ambulatory trauma surgeries (upper limb trauma, ankle fracture, tibial plateau fracture) and regional-specific referrals (periprosthetic hip fracture) were performed at a stand-alone elective site that accepted COVID-19-negative patients. Neck of femur fractures (NOFF) and all remaining non-NOFF (paediatric trauma, long bone injury) surgeries were performed at an acute site hospital (mixed green/blue site). Patients were swabbed for COVID-19 before surgery on both sites. Age, sex, nature of surgery, American Society of Anaesthesiologists (ASA) grade, associated comorbidity, length of stay, development of post-surgical COVID-19 infection, and post-surgical COVID-19-related deaths were collected. Results. At the elective site, 225 patients underwent orthopaedic trauma surgery; two became COVID-19-positive (0.9%) in the immediate perioperative period, neither of which was fatal. At the acute site, 93 patients underwent non-NOFF trauma surgery, of whom six became COVID-19-positive (6.5%) and three died. A further 84 patients underwent NOFF surgery, seven becoming COVID-19 positive (8.3%) and five died. Conclusion. At the elective site, the rate of COVID-19 infection following orthopaedic trauma surgery was low, at 0.9%. At the acute mixed site (typical district general hospital), for non-NOFF surgery there was a 6.5% incidence of post-surgical COVID-19 infection (seven-fold higher risk) with 50% COVID-19 mortality; for NOFF surgery, there was an 8.3% incidence of post-surgical COVID-19 infection, with 71% COVID-19 mortality. This is likely to have significance when planning a resumption of elective orthopaedic surgery and for consent to the patient. Cite this article: Bone Joint Open 2020;1-9:556–561


The Bone & Joint Journal
Vol. 100-B, Issue 9 | Pages 1253 - 1259
1 Sep 2018
Seewoonarain S Johnson AA Barrett M

Aims. Informed patient consent is a legal prerequisite endorsed by multiple regulatory institutions including the Royal College of Surgeons and the General Medical Council. It is also recommended that the provision of written information is available and may take the form of a Patient Information Leaflet (PIL) with multiple PILs available from leading orthopaedic institutions. PILs may empower the patient, improve compliance, and improve the patient experience. The national reading age in the United Kingdom is less than 12 years and therefore PILs should be written at a readability level not exceeding 12 years old. We aim to assess the readability of PILs currently provided by United Kingdom orthopaedic institutions. Patients and Methods. The readability of PILs on 58 common conditions provided by seven leading orthopaedic associations in January 2017, including the British Orthopaedic Association, British Hip Society, and the British Association of Spinal Surgeons, was assessed. All text in each PIL was analyzed using readability scores including the Flesch–Kincaid Grade Level (FKGL) and the Simple Measure of Gobbledygook (SMOG) test. Results. The mean FKGL was 10.4 (6.7 to 17.0), indicating a mean reading age of 15 years. The mean SMOG score was 12.8 (9.7 to 17.9) indicating a mean reading age of 17 years. Conclusion. Orthopaedic-related PILs do not comply with the recommended reading age, with some requiring graduate-level reading ability. Patients do not have access to appropriate orthopaedic-related PILs. Current publicly available PILs require further review to promote patient education and informed consent. Cite this article: Bone Joint J 2018;100-B:1253–9


The Bone & Joint Journal
Vol. 97-B, Issue 9 | Pages 1159 - 1161
1 Sep 2015
Foy MA

A recent Supreme Court ruling in the United Kingdom has significantly altered the emphasis of informed consent, moving from a historically ‘doctor-focused’ to a more ‘patient-focused’ approach, in line with the situation in other international jurisdictions. . The reasons for the change are discussed with some recommendations about how our attitudes need to change in the future. Cite this article: Bone Joint J 2015;97-B:1159–61


Bone & Joint Open
Vol. 4, Issue 2 | Pages 104 - 109
20 Feb 2023
Aslam AM Kennedy J Seghol H Khisty N Nicols TA Adie S

Aims. Patient decision aids have previously demonstrated an improvement in the quality of the informed consent process. This study assessed the effectiveness of detailed written patient information, compared to standard verbal consent, in improving postoperative recall in adult orthopaedic trauma patients. Methods. This randomized controlled feasibility trial was conducted at two teaching hospitals within the South Eastern Sydney Local Health District. Adult patients (age ≥ 18 years) pending orthopaedic trauma surgery between March 2021 and September 2021 were recruited and randomized to detailed or standard methods of informed consent using a random sequence concealed in sealed, opaque envelopes. The detailed group received procedure-specific written information in addition to the standard verbal consent. The primary outcome was total recall, using a seven-point interview-administered recall questionnaire at 72 hours postoperatively. Points were awarded if the participant correctly recalled details of potential complications (maximum three points), implants used (maximum three points), and postoperative instructions (maximum one point). Secondary outcomes included the anxiety subscale of the Hospital and Anxiety Depression Scale (HADS-A) and visual analogue scale (VAS) for pain collected at 24 hours preoperatively and 72 hours postoperatively. Additionally, the Patient Satisfaction Questionnaire Short Form (PSQ-18) measured satisfaction at 72 hours postoperatively. Results. A total of 60 patients were randomized, 32 to the standard group and 28 to the detailed group. Patients in the detailed group had significantly higher total recall score compared to the standard group (mean difference 1.29 points (95% confidence interval (CI) 0.51 to 2.08); p = 0.002). There were no differences in HADS-A (mean difference 0.39 (95% CI -2.11 to 2.88); p = 0.757), VAS pain (mean difference 5.71 (95% CI -22.25 to 11.11); p = 0.499), or PSQ-18 (mean difference 0.499; 95% CI -1.6 to 3.42; p = 0.392). Conclusion. Detailed written tools are useful in improving postoperative recall in adult orthopaedic trauma patients. Cite this article: Bone Jt Open 2023;4(2):104–109


Bone & Joint Open
Vol. 5, Issue 7 | Pages 565 - 569
9 Jul 2024
Britten S

Two discrete legal factors enable the surgeon to treat an injured patient the fully informed, autonomous consent of the adult patient with capacity via civil law; and the medical exception to the criminal law. This article discusses current concepts in consent in trauma; and also considers the perhaps less well known medical exception to the Offences against the Person Act 1861, which exempts surgeons from criminal liability as long as they provide ‘proper medical treatment’. Cite this article: Bone Jt Open 2024;5(7):565–569


The Bone & Joint Journal
Vol. 100-B, Issue 6 | Pages 687 - 692
1 Jun 2018
McCormack DJ Gulati A Mangwani J

Our aim in this paper was to investigate the guidelines and laws governing informed consent in the English-speaking world. We noted a recent divergence from medical paternalism within the United Kingdom, highlighted by the Montgomery v Lanarkshire Health Board ruling of 2015. We investigated the situation in the United Kingdom, Australia, New Zealand, Canada, and the United States of America. We read the national guidance regarding obtaining consent for surgical intervention for each country. We used the references from this guidance to identify the laws that helped inform the guidance, and reviewed the court documents for each case. There has been a trend towards a more patient-focused approach in consent in each country. Surgeons should be aware of the guidance and legal cases so that they can inform patients fully, and prevent legal problems if outdated practices are followed. Cite this article: Bone Joint J 2018;100-B:687–92


The Bone & Joint Journal
Vol. 101-B, Issue 4 | Pages 355 - 360
1 Apr 2019
Todd NV Birch NC

Informed consent is a very important part of surgical treatment. In this paper, we report a number of legal judgements in spinal surgery where there was no criticism of the surgical procedure itself. The fault that was identified was a failure to inform the patient of alternatives to, and material risks of, surgery, or overemphasizing the benefits of surgery. In one case, there was a promise that a specific surgeon was to perform the operation, which did not ensue. All of the faults in these cases were faults purely of the consenting process. In many cases, the surgeon claimed to have explained certain risks to the patient but was unable to provide proof of doing so. We propose a checklist that, if followed, would ensure that the surgeon would take their patients through the relevant matters but also, crucially, would act as strong evidence in any future court proceedings that the appropriate discussions had taken place. Although this article focuses on spinal surgery, the principles and messages are applicable to the whole of orthopaedic surgery. Cite this article: Bone Joint J 2019;101-B:355–360


The Bone & Joint Journal
Vol. 99-B, Issue 2 | Pages 147 - 150
1 Feb 2017
Costa ML Tutton E Achten J Grant R Slowther AM

Traditionally, informed consent for clinical research involves the patient reading an approved Participant Information Sheet, considering the information presented and having as much time as they need to discuss the study information with their friends and relatives, their clinical care and the research teams. This system works well in the ‘planned’ or ‘elective’ setting. But what happens if the patient requires urgent treatment for an injury or emergency?. This article reviews the legal framework which governs informed consent in the emergency setting, discusses how the approach taken may vary according to the details of the emergency and the treatment required, and reports on the patients’ view of providing consent following a serious injury. We then provide some practical tips for managing the process of informed consent in the context of injuries and emergencies. Cite this article: Bone Joint J 2017;99-B:147–150


The Bone & Joint Journal
Vol. 102-B, Issue 5 | Pages 550 - 555
1 May 2020
Birch N Todd NV

The cost of clinical negligence in the UK has continued to rise despite no increase in claims numbers from 2016 to 2019. In the US, medical malpractice claim rates have fallen each year since 2001 and the payout rate has stabilized. In Germany, malpractice claim rates for spinal surgery fell yearly from 2012 to 2017, despite the number of spinal operations increasing. In Australia, public healthcare claim rates were largely static from 2008 to 2013, but private claims rose marginally. The cost of claims rose during the period. UK and Australian trends are therefore out of alignment with other international comparisons. Many of the claims in orthopaedics occur as a result of “failure to warn”, i.e. lack of adequately documented and appropriate consent. The UK and USA have similar rates (26% and 24% respectively), but in Germany the rate is 14% and in Australia only 2%. This paper considers the drivers for the increased cost of clinical negligence claims in the UK compared to the USA, Germany and Australia, from a spinal and orthopaedic point of view, with a focus on “failure to warn” and lack of compliance with the principles established in February 2015 in the Supreme Court in the case of Montgomery v Lanarkshire Health Board. The article provides a description of the prevailing medicolegal situation in the UK and also calculates, from publicly available data, the cost to the public purse of the failure to comply with the principles established. It shows that compliance with the Montgomery principles would have an immediate and lasting positive impact on the sums paid by NHS Resolution to settle negligence cases in a way that has already been established in the USA. Cite this article: Bone Joint J 2020;102-B(5):550–555


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 4 | Pages 422 - 423
1 Apr 2008
Atrey A Leslie I Carvell J Gupte C Shepperd JAN Powell J Gibb PA

The British Orthopaedic Association has endorsed a website, . www.orthoconsent.com. , allowing surgeons free access to a bank of pre-written consent forms. These are designed to improve the level of information received by the patient and lessen the risk of successful litigation against surgeons and Health Trusts


Bone & Joint 360
Vol. 5, Issue 3 | Pages 38 - 40
1 Jun 2016
Worlock PH


Bone & Joint 360
Vol. 4, Issue 3 | Pages 33 - 34
1 Jun 2015
Foy MA


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 1 | Pages 2 - 7
1 Jan 2006
Lemaire R


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 1 | Pages 16 - 18
1 Jan 2006
Leigh B


Bone & Joint Open
Vol. 2, Issue 8 | Pages 631 - 637
10 Aug 2021
Realpe AX Blackstone J Griffin DR Bing AJF Karski M Milner SA Siddique M Goldberg A

Aims. A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. Methods. We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment. Results. Recruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on equipoise. Clinicians expressed concerns that the trial may not show significant differences in the treatments, validating their equipoise. However, they experienced role conflicts due to their own preference and perceived patient preference for an intervention arm. Conclusion. This study provided initial information about barriers to recruitment to an orthopaedic randomized controlled trial. We shared these findings in an all-site investigators’ meeting and encouraged researchers to find solutions to identified barriers; this led to the successful completion of recruitment. Complex trials may benefit for using of a mixed-methods approach to mitigate against recruitment failure, and to improve patient participation and informed consent. Cite this article: Bone Jt Open 2021;2(8):631–637


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 843 - 849
1 Aug 2023
Grandhi TSP Fontalis A Raj RD Kim WJ Giebaly DE Haddad FS

Telehealth has the potential to change the way we approach patient care. From virtual consenting to reducing carbon emissions, costs, and waiting times, it is a powerful tool in our clinical armamentarium. There is mounting evidence that remote diagnostic evaluation and decision-making have reached an acceptable level of accuracy and can safely be adopted in orthopaedic surgery. Furthermore, patients’ and surgeons’ satisfaction with virtual appointments are comparable to in-person consultations. Challenges to the widespread use of telehealth should, however, be acknowledged and include the cost of installation, training, maintenance, and accessibility. It is also vital that clinicians are conscious of the medicolegal and ethical considerations surrounding the medium and adhere strictly to the relevant data protection legislation and storage framework. It remains to be seen how organizations harness the full spectrum of the technology to facilitate effective patient care. Cite this article: Bone Joint J 2023;105-B(8):843–849


Bone & Joint Open
Vol. 4, Issue 10 | Pages 782 - 790
18 Oct 2023
Hamilton DF Gaston P Macpherson GJ Simpson P Clement ND

Aims. The primary aim of this study is to assess the survival of the uncemented hydroxyapatite (HA) coated Trident II acetabular component as part of a hybrid total hip arthroplasty (THA) using a cemented Exeter stem. The secondary aims are to assess the complications, joint-specific function, health-related quality of life, and radiological signs of loosening of the acetabular component. Methods. A single-centre, prospective cohort study of 125 implants will be undertaken. Patients undergoing hybrid THA at the study centre will be recruited. Inclusion criteria are patients suitable for the use of the uncemented acetabular component, aged 18 to 75 years, willing and able to comply with the study protocol, and provide informed consent. Exclusion criteria includes patients not meeting study inclusion criteria, inadequate bone stock to support fixation of the prosthesis, a BMI > 40 kg/m. 2. , or THA performed for pain relief in those with severely restricted mobility. Results. Implant survival, complications, functional outcomes and radiological assessment up to ten years following index THA (one, two, five, seven, and ten years) will be performed. Functional assessment will include the Oxford Hip Score, Forgotten Joint Score, 12-Item Short Form Health Survey, EuroQol five-dimension health questionnaire, and pain and patient satisfaction. Radiological assessment with assess for acetabula lucent lines, lysis, and loosening according to DeLee and Charnley zones. Conclusion. This study is part of a stepwise introduction of a new device to orthopaedic practice, and careful monitoring of implants should be carried out as part of the Beyond Compliance principles. The results of this study will provide functional, radiological, and survival data to either support the ongoing use of the HA acetabulum or highlight potential limitations of this new implant before wide adoption. Cite this article: Bone Jt Open 2023;4(10):782–790


Bone & Joint Open
Vol. 2, Issue 10 | Pages 865 - 870
20 Oct 2021
Wignadasan W Mohamed A Kayani B Magan A Plastow R Haddad FS

Aims. The COVID-19 pandemic drastically affected elective orthopaedic services globally as routine orthopaedic activity was largely halted to combat this global threat. Our institution (University College London Hospital, UK) previously showed that during the first peak, a large proportion of patients were hesitant to be listed for their elective lower limb procedure. The aim of this study is to assess if there is a patient perception change towards having elective surgery now that we have passed the peak of the second wave of the pandemic. Methods. This is a prospective study of 100 patients who were on the waiting list of a single surgeon for an elective hip or knee procedure. Baseline characteristics including age, American Society of Anesthesiologists (ASA) grade, COVID-19 risk, procedure type, and admission type were recorded. The primary outcome was patient consent to continue with their scheduled surgical procedure. Subgroup analysis was also conducted to define if any specific patient factors influenced decision to continue with surgery. Results. Overall, 88 patients (88%) were happy to continue with their scheduled procedure at the earliest opportunity. Patients with an ASA grade I were most likely to agree to surgery, followed by patients with ASA grades II, then those with grade III (93.3%, 88.7%, and 78.6% willingness, respectively). Patients waitlisted for an injection were least likely to consent to surgery, with just 73.7% agreeing. In all, there was a large increase in the proportion of patient willingness to continue with surgery compared to our initial study during the first wave of the pandemic. Conclusion. As COVID-19 lockdown restrictions are lifted after the second peak of the pandemic, we are seeing greater willingness to continue with scheduled orthopaedic surgery, reinforcing a change in patient perception towards having elective surgery. However, we must continue with strict COVID-19 precautions in order to minimize viral transmission as we increase our elective orthopaedic services going forward. Cite this article: Bone Jt Open 2021;2(10):865–870


Bone & Joint Open
Vol. 2, Issue 10 | Pages 785 - 795
1 Oct 2021
Matar HE Porter PJ Porter ML

Aims. Metal allergy in knee arthroplasty patients is a controversial topic. We aimed to conduct a scoping review to clarify the management of metal allergy in primary and revision total knee arthroplasty (TKA). Methods. Studies were identified by searching electronic databases: Cochrane Central Register of Controlled Trials, Ovid MEDLINE, and Embase, from their inception to November 2020, for studies evaluating TKA patients with metal hypersensitivity/allergy. All studies reporting on diagnosing or managing metal hypersensitivity in TKA were included. Data were extracted and summarized based on study design, study population, interventions and outcomes. A practical guide is then formulated based on the available evidence. Results. We included 38 heterogeneous studies (two randomized controlled trials, six comparative studies, 19 case series, and 11 case reports). The evidence indicates that metal hypersensitivity is a rare complication with some histopathological features leading to pain and dissatisfaction with no reliable screening tests preoperatively. Hypoallergenic implants are viable alternatives for patients with self-reported/confirmed metal hypersensitivity if declared preoperatively; however, concerns remain over their long-term outcomes with ceramic implants outperforming titanium nitride-coated implants and informed consent is paramount. For patients presenting with painful TKA, metal hypersensitivity is a diagnosis of exclusion where patch skin testing, lymphocyte transformation test, and synovial biopsies are useful adjuncts before revision surgery is undertaken to hypoallergenic implants with shared decision-making and informed consent. Conclusion. Using the limited available evidence in the literature, we provide a practical approach to metal hypersensitivity in TKA patients. Future national/registry-based studies are needed to identify the scale of metal hypersensitivity, agreed diagnostic criteria, and management strategies. Cite this article: Bone Jt Open 2021;2(10):785–795


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 912 - 919
1 Aug 2023
Cunningham LJ Walton M Bale S Trail IA

Aims. Reverse total shoulder arthroplasty (rTSA) can be used in complex cases when the glenoid requires reconstruction. In this study, a baseplate with composite bone autograft and a central trabecular titanium peg was implanted, and its migration was assessed for two years postoperatively using radiostereometric analysis (RSA). Methods. A total of 14 patients who underwent a rTSA with an autograft consented to participate. Of these, 11 had a primary rTSA using humeral head autograft and three had a revision rTSA with autograft harvested from the iliac crest. The mean age of the patients was 66 years (39 to 81). Tantalum beads were implanted in the scapula around the glenoid. RSA imaging (stereographic radiographs) was undertaken immediately postoperatively and at three, six, 12, and 24 months. Analysis was completed using model-based RSA software. Outcomes were collected preoperatively and at two years postoperatively, including the Oxford Shoulder Score, the American Shoulder and Elbow Score, and a visual analogue score for pain. A Constant score was also obtained for the assessment of strength and range of motion. Results. RSA analysis showed a small increase in all translation and rotational values up to six months postoperatively, consistent with settling of the implant. The mean values plateaued by 12 months, with no evidence of further migration. In four patients, there was significant variation outside the mean, which corresponded to postoperative complications. There was a significant improvement in the clinical and patient-reported outcomes from the preoperative values to those at two years postoperatively (p < 0.001). Conclusion. These findings show, using RSA, that a glenoid baseplate composite of a trabecular titanium peg with autograft stabilizes within the glenoid about 12 months after surgery, and reinforce findings from a previous study of this implant/graft with CT scans at two years postoperatively, indicating that this type of structural composite results in sound early fixation. Cite this article: Bone Joint J 2023;105-B(8):912–919


Aims. Osteochondral lesions of the talus (OLT) are a common cause of disability and chronic ankle pain. Many operative treatment strategies have been introduced; however, they have their own disadvantages. Recently lesion repair using autologous cartilage chip has emerged therefore we investigated the efficacy of particulated autologous cartilage transplantation (PACT) in OLT. Methods. We retrospectively analyzed 32 consecutive symptomatic patients with OLT who underwent PACT with minimum one-year follow-up. Standard preoperative radiography and MRI were performed for all patients. Follow-up second-look arthroscopy or MRI was performed with patient consent approximately one-year postoperatively. Magnetic resonance Observation of Cartilage Repair Tissue (MOCART) score and International Cartilage Repair Society (ICRS) grades were used to evaluate the quality of the regenerated cartilage. Clinical outcomes were assessed using the pain visual analogue scale (VAS), Foot Function Index (FFI), and Foot Ankle Outcome Scale (FAOS). Results. All patients had ICRS grade IV cartilage lesions, except for one (ICRS grade III). The paired MOCART scores significantly improved from 42.5 (SD 1.53) to 63.5 (SD 22.60) (p = 0.025) in ten patients. Seven patients agreed to undergo second-look arthroscopy; 5 patients had grade I (normal) ICRS scores and two patients had grade II (nearly normal) ICRS scores. VAS, FFI, and all subscales of FAOS were significantly improved postoperatively (p ≤ 0.003). Conclusion. PACT significantly improved the clinical, radiological, and morphological outcomes of OLT. We consider this to be a safe and effective surgical method based on the short-term clinical results of this study. Cite this article: Bone Jt Open 2023;4(12):942–947


The Bone & Joint Journal
Vol. 105-B, Issue 3 | Pages 315 - 322
1 Mar 2023
Geere JH Swamy GN Hunter PR Geere JL Lutchman LN Cook AJ Rai AS

Aims. To identify the incidence and risk factors for five-year same-site recurrent disc herniation (sRDH) after primary single-level lumbar discectomy. Secondary outcome was the incidence and risk factors for five-year sRDH reoperation. Methods. A retrospective study was conducted using prospectively collected data and patient-reported outcome measures, including the Oswestry Disability Index (ODI), between 2008 and 2019. Postoperative sRDH was identified from clinical notes and the centre’s MRI database, with all imaging providers in the region checked for missing events. The Kaplan-Meier method was used to calculate five-year sRDH incidence. Cox proportional hazards model was used to identify independent variables predictive of sRDH, with any variable not significant at the p < 0.1 level removed. Hazard ratios (HRs) were calculated with 95% confidence intervals (CIs). Results. Complete baseline data capture was available for 733 of 754 (97.2%) consecutive patients. Median follow-up time for censored patients was 2.2 years (interquartile range (IQR) 1.0 to 5.0). sRDH occurred in 63 patients at a median 0.8 years (IQR 0.5 to 1.7) after surgery. The five-year Kaplan-Meier estimate for sRDH was 12.1% (95% CI 9.5 to 15.4), sRDH reoperation was 7.5% (95% CI 5.5 to 10.2), and any-procedure reoperation was 14.1% (95% CI 11.1 to 17.5). Current smoker (HR 2.12 (95% CI 1.26 to 3.56)) and higher preoperative ODI (HR 1.02 (95% CI 1.00 to 1.03)) were independent risk factors associated with sRDH. Current smoker (HR 2.15 (95% CI 1.12 to 4.09)) was an independent risk factor for sRDH reoperation. Conclusion. This is one of the largest series to date which has identified current smoker and higher preoperative disability as independent risk factors for sRDH. Current smoker was an independent risk factor for sRDH reoperation. These findings are important for spinal surgeons and rehabilitation specialists in risk assessment, consenting patients, and perioperative management. Cite this article: Bone Joint J 2023;105-B(3):315–322


Bone & Joint Open
Vol. 4, Issue 2 | Pages 110 - 119
21 Feb 2023
Macken AA Prkić A van Oost I Spekenbrink-Spooren A The B Eygendaal D

Aims. The aim of this study is to report the implant survival and factors associated with revision of total elbow arthroplasty (TEA) using data from the Dutch national registry. Methods. All TEAs recorded in the Dutch national registry between 2014 and 2020 were included. The Kaplan-Meier method was used for survival analysis, and a logistic regression model was used to assess the factors associated with revision. Results. A total of 514 TEAs were included, of which 35 were revised. The five-year implant survival was 91%. Male sex, a higher BMI, and previous surgery to the same elbow showed a statistically significant association with revision (p < 0.036). Of the 35 revised implants, ten (29%) underwent a second revision. Conclusion. This study reports a five-year implant survival of TEA of 91%. Patient factors associated with revision are defined and can be used to optimize informed consent and shared decision-making. There was a high rate of secondary revisions. Cite this article: Bone Jt Open 2023;4(2):110–119


Bone & Joint Open
Vol. 2, Issue 3 | Pages 198 - 201
1 Mar 2021
Habeebullah A Rajgor HD Gardner A Jones M

Aims. The British Spine Registry (BSR) was introduced in May 2012 to be used as a web-based database for spinal surgeries carried out across the UK. Use of this database has been encouraged but not compulsory, which has led to a variable level of engagement in the UK. In 2019 NHS England and NHS Improvement introduced a new Best Practice Tariff (BPT) to encourage input of spinal surgical data on the BSR. The aim of our study was to assess the impact of the spinal BPT on compliance with the recording of surgical data on the BSR. Methods. A retrospective review of data was performed at a tertiary spinal centre between 2018 to 2020. Data were collated from electronic patient records, theatre operating lists, and trust-specific BSR data. Information from the BSR included operative procedures (mandatory), patient consent, email addresses, and demographic details. We also identified Healthcare Resource Groups (HRGs) which qualified for BPT. Results. A total of 3,587 patients were included in our study. Of these, 1,684 patients were eligible for BPT. Between 2018 and 2019 269/974 (28%) records were complete on the BSR for those that would be eligible for BPT. Following introduction of BPT in 2019, 671/710 (95%) records were complete having filled in the mandatory data (p < 0.001). Patient consent to data collection also improved from 62% to 93%. Email details were present in 43% of patients compared with 68% following BPT introduction. Conclusion. Our study found that following the introduction of a BPT, there was a statistically significant improvement in BSR record completion compliance in our unit. The BPT offers a financial incentive which can help generate further income for trusts. National data input into the BSR is important to assess patient outcome following spinal surgery. The BSR can also aid future research in spinal surgery. Cite this article: Bone Jt Open 2021;2-3:198–201


Aims. Nearly 99,000 total knee arthroplasties (TKAs) are performed in UK annually. Despite plenty of research, the satisfaction rate of this surgery is around 80%. One of the important intraoperative factors affecting the outcome is alignment. The relationship between joint obliquity and functional outcomes is not well understood. Therefore, a study is required to investigate and compare the effects of two types of alignment (mechanical and kinematic) on functional outcomes and range of motion. Methods. The aim of the study is to compare navigated kinematically aligned TKAs (KA TKAs) with navigated mechanically aligned TKA (MA TKA) in terms of function and ROM. We aim to recruit a total of 96 patients in the trial. The patients will be recruited from clinics of various consultants working in the trust after screening them for eligibility criteria and obtaining their informed consent to participate in this study. Randomization will be done prior to surgery by a software. The primary outcome measure will be the Knee injury and Osteoarthritis Outcome Score The secondary outcome measures include Oxford Knee Score, ROM, EuroQol five-dimension questionnaire, EuroQol visual analogue scale, 12-Item Short-Form Health Survey (SF-12), and Forgotten Joint Score. The scores will be calculated preoperatively and then at six weeks, six months, and one year after surgery. The scores will undergo a statistical analysis. Discussion. There is no clear evidence on the best alignment for a knee arthroplasty. This randomized controlled trial will test the null hypothesis that navigated KA TKAs do not perform better than navigated MA TKAs. Cite this article: Bone Jt Open 2021;2(11):945–950


Bone & Joint Open
Vol. 1, Issue 6 | Pages 267 - 271
12 Jun 2020
Chang J Wignadasan W Kontoghiorghe C Kayani B Singh S Plastow R Magan A Haddad F

Aims. As the peak of the COVID-19 pandemic passes, the challenge shifts to safe resumption of routine medical services, including elective orthopaedic surgery. Protocols including pre-operative self-isolation, COVID-19 testing, and surgery at a non-COVID-19 site have been developed to minimize risk of transmission. Despite this, it is likely that many patients will want to delay surgery for fear of contracting COVID-19. The aim of this study is to identify the number of patients who still want to proceed with planned elective orthopaedic surgery in this current environment. Methods. This is a prospective, single surgeon study of 102 patients who were on the waiting list for an elective hip or knee procedure during the COVID-19 pandemic. Baseline characteristics including age, ASA grade, COVID-19 risk, procedure type, surgical priority, and admission type were recorded. The primary outcome was patient consent to continue with planned surgical care after resumption of elective orthopaedic services. Subgroup analysis was also performed to determine if any specific patient factors influenced the decision to proceed with surgery. Results. Overall, 58 patients (56.8%) wanted to continue with planned surgical care at the earliest possibility. Patients classified as ASA I and ASA II were more likely to agree to surgery (60.5% and 60.0%, respectively) compared to ASA III and ASA IV patients (44.4% and 0.0%, respectively) (p = 0.01). In addition, patients undergoing soft tissue knee surgery were more likely to consent to surgery (90.0%) compared to patients undergoing primary hip arthroplasty (68.6%), primary knee arthroplasty (48.7%), revision hip or knee arthroplasty (0.0%), or hip and knee injections (43.8%) (p = 0.03). Conclusion. Restarting elective orthopaedic services during the COVID-19 pandemic remains a significant challenge. Given the uncertain environment, it is unsurprising that only 56% of patients were prepared to continue with their planned surgical care upon resumption of elective services. Cite this article: Bone Joint Open 2020;1-6:267–271


The Bone & Joint Journal
Vol. 104-B, Issue 4 | Pages 519 - 528
1 Apr 2022
Perry DC Arch B Appelbe D Francis P Craven J Monsell FP Williamson P Knight M

Aims. The aim of this study was to inform the epidemiology and treatment of slipped capital femoral epiphysis (SCFE). Methods. This was an anonymized comprehensive cohort study, with a nested consented cohort, following the the Idea, Development, Exploration, Assessment, Long-term study (IDEAL) framework. A total of 143 of 144 hospitals treating SCFE in Great Britain participated over an 18-month period. Patients were cross-checked against national administrative data and potential missing patients were identified. Clinician-reported outcomes were collected until two years. Patient-reported outcome measures (PROMs) were collected for a subset of participants. Results. A total of 486 children (513 hips) were newly affected, with a median of two patients (interquartile range 0 to 4) per hospital. The annual incidence was 3.34 (95% confidence interval (CI) 3.01 to 3.67) per 100,000 six- to 18-year-olds. Time to diagnosis in stable disease was increased in severe deformity. There was considerable variation in surgical strategy among those unable to walk at diagnosis (66 urgent surgery vs 43 surgery after interval delay), those with severe radiological deformity (34 fixation with deformity correction vs 36 without correction) and those with unaffected opposite hips (120 prophylactic fixation vs 286 no fixation). Independent risk factors for avascular necrosis (AVN) were the inability of the child to walk at presentation to hospital (adjusted odds ratio (aOR) 4.4 (95% CI 1.7 to 11.4)) and surgical technique of open reduction and internal fixation (aOR 7.5 (95% CI 2.4 to 23.2)). Overall, 33 unaffected untreated opposite hips (11.5%) were treated for SCFE by two-year follow-up. Age was the only independent risk factor for contralateral SCFE, with age under 12.5 years the optimal cut-off to define ‘at risk’. Of hips treated with prophylactic fixation, none had SCFE, though complications included femoral fracture, AVN, and revision surgery. PROMs demonstrated the marked impact on quality of life on the child because of SCFE. Conclusion. The experience of individual hospitals is limited and mechanisms to consolidate learning may enhance care. Diagnostic delays were common and radiological severity worsened with increasing time to diagnosis. There was unexplained variation in treatment, some of which exposes children to significant risks that should be evaluated through randomized controlled trials. Cite this article: Bone Joint J 2022;104-B(4):519–528


Bone & Joint Open
Vol. 3, Issue 3 | Pages 252 - 260
17 Mar 2022
Badge H Churches T Xuan W Naylor JM Harris IA

Aims. Antibiotic prophylaxis involving timely administration of appropriately dosed antibiotic is considered effective to reduce the risk of surgical site infection (SSI) after total hip and total knee arthroplasty (THA/TKA). Cephalosporins provide effective prophylaxis, although evidence regarding the optimal timing and dosage of prophylactic antibiotics is inconclusive. The aim of this study is to examine the association between cephalosporin prophylaxis dose, timing, and duration, and the risk of SSI after THA/TKA. Methods. A prospective multicentre cohort study was undertaken in consenting adults with osteoarthritis undergoing elective primary TKA/THA at one of 19 high-volume Australian public/private hospitals. Data were collected prior to and for one-year post surgery. Logistic regression was undertaken to explore associations between dose, timing, and duration of cephalosporin prophylaxis and SSI. Data were analyzed for 1,838 participants. There were 264 SSI comprising 63 deep SSI (defined as requiring intravenous antibiotics, readmission, or reoperation) and 161 superficial SSI (defined as requiring oral antibiotics) experienced by 249 (13.6%) participants within 365 days of surgery. Results. In adjusted modelling, factors associated with a significant reduction in any SSI and deep SSI included: correct weight-adjusted dose (any SSI; adjusted odds ratio (aOR) 0.68 (95% confidence interval (CI) 0.47 to 0.99); p = 0.045); commencing preoperative cephalosporin within 60 minutes (any SSI, aOR 0.56 (95% CI 0.36 to 0.89); p = 0.012; deep SSI, aOR 0.29 (95% CI 0.15 to 0.59); p < 0.001) or 60 minutes or longer prior to skin incision (aOR 0.35 (95% CI 0.17 to 0.70); p = 0.004; deep SSI, AOR 0.27 (95% CI 0.09 to 0.83); p = 0.022), compared to at or after skin incision. Other factors significantly associated with an increased risk of any SSI, but not deep SSI alone, were receiving a non-cephalosporin antibiotic preoperatively (aOR 1.35 (95% CI 1.01 to 1.81); p = 0.044) and changing cephalosporin dose (aOR 1.76 (95% CI 1.22 to 2.57); p = 0.002). There was no difference in risk of any or deep SSI between the duration of prophylaxis less than or in excess of 24 hours. Conclusion. Ensuring adequate, weight-adjusted dosing and early, preoperative delivery of prophylactic antibiotics may reduce the risk of SSI in THA/TKA, whereas the duration of prophylaxis beyond 24 hours is unnecessary. Cite this article: Bone Jt Open 2022;3(3):252–260


The Bone & Joint Journal
Vol. 100-B, Issue 10 | Pages 1352 - 1358
1 Oct 2018
Clough TM Alvi F Majeed H

Aims. Total ankle arthroplasty (TAA) surgery is complex and attracts a wide variety of complications. The literature lacks consistency in reporting adverse events and complications. The aim of this article is to provide a comprehensive analysis of each of these complications from a literature review, and to compare them with rates from our Unit, to aid clinicians with the process of informed consent. Patients and Methods. A total of 278 consecutive total ankle arthroplasties (251 patients), performed by four surgeons over a six-year period in Wrightington Hospital (Wigan, United Kingdom) were prospectively reviewed. There were 143 men and 108 women with a mean age of 64 years (41 to 86). The data were recorded on each follow-up visit. Any complications either during initial hospital stay or subsequently reported on follow-ups were recorded, investigated, monitored, and treated as warranted. Literature search included the studies reporting the outcomes and complications of TAA implants. Results. There were wound-healing problems in nine ankles (3.2%), superficial infection in 20 ankles (7.2%), and deep infection in six ankles (2.2%). Intraoperative fractures occurred in medial malleoli in 27 ankles (9.7%) and in lateral malleoli in four ankles (1.4%). Aseptic loosening and osteolysis were seen 16 ankles (5.8%). Fracture of the polyethylene component occurred in one ankle (0.4%) and edge-loading in seven ankles (2.5%). We observed medial gutter pain in 31 ankles (11.1%). The incidence of thromboembolism occurred in two ankles (0.7%). The results were found to be comparable to the previously reported complications of total ankle arthroplasty in the literature. Conclusion. Total ankle arthroplasty continues to evolve and improve the ankle function. Despite high overall complication rates with TAA surgery, most complications appear to be minor and do not affect final clinical outcome. Our results and literature review will help in the consent process and provide detailed complication rates for an informed consent. Cite this article: Bone Joint J 2018;100-B:1352–8


Bone & Joint Research
Vol. 10, Issue 10 | Pages 650 - 658
1 Oct 2021
Sanghani-Kerai A Black C Cheng SO Collins L Schneider N Blunn G Watson F Fitzpatrick N

Aims. This study investigates the effects of intra-articular injection of adipose-derived mesenchymal stem cells (AdMSCs) and platelet-rich plasma (PRP) on lameness, pain, and quality of life in osteoarthritic canine patients. Methods. With informed owner consent, adipose tissue collected from adult dogs diagnosed with degenerative joint disease was enzymatically digested and cultured to passage 1. A small portion of cells (n = 4) surplus to clinical need were characterized using flow cytometry and tri-lineage differentiation. The impact and degree of osteoarthritis (OA) was assessed using the Liverpool Osteoarthritis in Dogs (LOAD) score, Modified Canine Osteoarthritis Staging Tool (mCOAST), kinetic gait analysis, and diagnostic imaging. Overall, 28 joints (25 dogs) were injected with autologous AdMSCs and PRP. The patients were followed up at two, four, eight, 12, and 24 weeks. Data were analyzed using two related-samples Wilcoxon signed-rank or Mann-Whitney U tests with statistical significance set at p < 0.05. Results. AdMSCs demonstrated stem cell-like characteristics. LOAD scores were significantly lower at week 4 compared with preinjection (p = 0.021). The mCOAST improved significantly after three months (p = 0.001) and six months (p = 0.001). Asymmmetry indices decreased from four weeks post-injection and remained significantly lower at six months (p = 0.025). Conclusion. These improvements in quality of life, reduction in pain on examination, and improved symmetry in dogs injected with AdMSCs and PRP support the effectiveness of this combined treatment for symptom modification in canine OA for six months. Cite this article: Bone Joint Res 2021;10(10):650–658


The Bone & Joint Journal
Vol. 103-B, Issue 9 | Pages 1464 - 1471
1 Sep 2021
Barker TP Steele N Swamy G Cook A Rai A Crawford R Lutchman L

Aims. Cauda equina syndrome (CES) can be associated with chronic severe lower back pain and long-term autonomic dysfunction. This study assesses the recently defined core outcome set for CES in a cohort of patients using validated questionnaires. Methods. Between January 2005 and December 2019, 82 patients underwent surgical decompression for acute CES secondary to massive lumbar disc prolapse at our hospital. After review of their records, patients were included if they presented with the clinical and radiological features of CES, then classified as CES incomplete (CESI) or with painless urinary retention (CESR) in accordance with guidelines published by the British Association of Spinal Surgeons. Patients provided written consent and completed a series of questionnaires. Results. In total, 61 of 82 patients returned a completed survey. Their mean age at presentation was 43 years (20 to 77; SD 12.7), and the mean duration of follow-up 58.2 months (11 to 182; SD 45.3). Autonomic dysfunction was frequent: 33% of patients reported bladder dysfunction, and 10% required a urinary catheter. There was a 38% and 53% incidence of bowel and sexual dysfunction, respectively: 47% of patients reported genital numbness. A total of 67% reported significant back pain: 44% required further investigation and 10% further intervention for the management of lower back pain. Quality of life was lower than expected when corrected for age and sex. Half the patients reported moderate or worse depression, and 40% of patients of working age could no longer work due to problems attributable to CES. Urinary and faecal incontinence, catheter use, sexual dysfunction, and genital numbness were significantly more common in patients with CESR. Conclusion. This study reports the long-term outcome of patients with CES and is the first to use validated patient-reported outcome measures to assess the CES Core Outcome Set. Persistent severe back pain and on-going autonomic dysfunction were frequently reported at a mean follow-up of five years. Cite this article: Bone Joint J 2021;103-B(9):1464–1471


The Bone & Joint Journal
Vol. 104-B, Issue 4 | Pages 510 - 518
1 Apr 2022
Perry DC Arch B Appelbe D Francis P Craven J Monsell FP Williamson P Knight M

Aims. The aim of this study was to evaluate the epidemiology and treatment of Perthes’ disease of the hip. Methods. This was an anonymized comprehensive cohort study of Perthes’ disease, with a nested consented cohort. A total of 143 of 144 hospitals treating children’s hip disease in the UK participated over an 18-month period. Cases were cross-checked using a secondary independent reporting network of trainee surgeons to minimize those missing. Clinician-reported outcomes were collected until two years. Patient-reported outcome measures (PROMs) were collected for a subset of participants. Results. Overall, 371 children (396 hips) were newly affected by Perthes’ disease arising from 63 hospitals, with a median of two patients (interquartile range 1.0 to 5.5) per hospital. The annual incidence was 2.48 patients (95% confidence interval (CI) 2.20 to 2.76) per 100,000 zero- to 14-year-olds. Of these, 117 hips (36.4%) were treated surgically. There was considerable variation in the treatment strategy, and an optimized decision tree identified joint stiffness and age above eight years as the key determinants for containment surgery. A total of 348 hips (88.5%) had outcomes to two years, of which 227 were in the late reossification stage for which a hip shape outcome (Stulberg grade) was assigned. The independent predictors of a poorer radiological outcome were female sex (odds ratio (OR) 2.27 (95% CI 1.19 to 4.35)), age above six years (OR 2.62 (95% CI (1.30 to 5.28)), and over 50% radiological collapse at inclusion (OR 2.19 (95% CI 0.99 to 4.83)). Surgery had no effect on radiological outcomes (OR 1.03 (95% CI 0.55 to 1.96)). PROMs indicated the marked effect of the disease on the child, which persisted at two years. Conclusion. Despite the frequency of containment surgery, we found no evidence of improved outcomes. There appears to be a sufficient case volume and community equipoise among surgeons to embark on a randomized clinical trial to definitively investigate the effectiveness of containment surgery. Cite this article: Bone Joint J 2022;104-B(4):510–518


The Bone & Joint Journal
Vol. 103-B, Issue 11 | Pages 1678 - 1685
1 Nov 2021
Abdelaziz H Schröder M Shum Tien C Ibrahim K Gehrke T Salber J Citak M

Aims. One-stage revision hip arthroplasty for periprosthetic joint infection (PJI) has several advantages; however, resection of the proximal femur might be necessary to achieve higher success rates. We investigated the risk factors for resection and re-revisions, and assessed complications and subsequent re-revisions. Methods. In this single-centre, case-control study, 57 patients who underwent one-stage revision arthroplasty for PJI of the hip and required resection of the proximal femur between 2009 and 2018 were identified. The control group consisted of 57 patients undergoing one-stage revision without bony resection. Logistic regression analysis was performed to identify any correlation with resection and the risk factors for re-revisions. Rates of all-causes re-revision, reinfection, and instability were compared between groups. Results. Patients who required resection of the proximal femur were found to have a higher all-cause re-revision rate (29.8% vs 10.5%; p = 0.018), largely due to reinfection (15.8% vs 0%; p = 0.003), and dislocation (8.8% vs 10.5%; p = 0.762), and showed higher rate of in-hospital wound haematoma requiring aspiration or evacuation (p = 0.013), and wound revision (p = 0.008). The use of of dual mobility components/constrained liner in the resection group was higher than that of controls (94.7% vs 36.8%; p < 0.001). The presence and removal of additional metal hardware (odds ratio (OR) = 7.2), a sinus tract (OR 4), ten years’ time interval between primary implantation and index infection (OR 3.3), and previous hip revision (OR 1.4) increased the risk of proximal femoral resection. A sinus tract (OR 9.2) and postoperative dislocation (OR 281.4) were associated with increased risk of subsequent re-revisions. Conclusion. Proximal femoral resection during one-stage revision hip arthroplasty for PJI may be required to reduce the risk of of recurrent or further infection. Patients with additional metalware needing removal or transcortical sinus tracts and chronic osteomyelitis are particularly at higher risk of needing proximal femoral excision. However, radical resection is associated with higher surgical complications and increased re-revision rates. The use of constrained acetabular liners and dual mobility components maintained an acceptable dislocation rate. These results, including identified risk factors, may aid in preoperative planning, patient consultation and consent, and intraoperative decision-making. Cite this article: Bone Joint J 2021;103-B(11):1678–1685


The Bone & Joint Journal
Vol. 103-B, Issue 10 | Pages 1578 - 1585
1 Oct 2021
Abram SGF Sabah SA Alvand A Price AJ

Aims. To compare rates of serious adverse events in patients undergoing revision knee arthroplasty with consideration of the indication for revision (urgent versus elective indications), and compare these with primary arthroplasty and re-revision arthroplasty. Methods. Patients undergoing primary knee arthroplasty were identified in the national Hospital Episode Statistics (HES) between 1 April 1997 to 31 March 2017. Subsequent revision and re-revision arthroplasty procedures in the same patients and same knee were identified. The primary outcome was 90-day mortality and a logistic regression model was used to investigate factors associated with 90-day mortality and secondary adverse outcomes, including infection (undergoing surgery), pulmonary embolism, myocardial infarction, and stroke. Urgent indications for revision arthroplasty were defined as infection or fracture, and all other indications (e.g. loosening, instability, wear) were included in the elective indications cohort. Results. A total of 939,021 primary knee arthroplasty procedures were included (939,021 patients), of which 40,854 underwent subsequent revision arthroplasty, and 9,100 underwent re-revision arthroplasty. Revision surgery for elective indications was associated with a 90-day rate of mortality of 0.44% (135/30,826; 95% confidence interval (CI) 0.37 to 0.52) which was comparable to primary knee arthroplasty (0.46%; 4,292/939,021; 95% CI 0.44 to 0.47). Revision arthroplasty for infection was associated with a much higher mortality of 2.04% (184/9037; 95% CI 1.75 to 2.35; odds ratio (OR) 3.54; 95% CI 2.81 to 4.46), as was revision for periprosthetic fracture at 5.25% (52/991; 95% CI 3.94 to 6.82; OR 6.23; 95% CI 4.39 to 8.85). Higher rates of pulmonary embolism, myocardial infarction, and stroke were also observed in the infection and fracture cohort. Conclusion. Patients undergoing revision arthroplasty for urgent indications (infection or fracture) are at higher risk of mortality and serious adverse events in comparison to primary knee arthroplasty and revision arthroplasty for elective indications. These findings will be important for patient consent and shared decision-making and should inform service design for this patient cohort. Cite this article: Bone Joint J 2021;103-B(10):1578–1585


Aims. Slipped capital femoral epiphysis (SCFE) is one of the most common hip diseases of adolescence that can cause marked disability, yet there is little robust evidence to guide treatment. Fundamental aspects of the disease, such as frequency, are unknown and consequently the desire of clinicians to undertake robust intervention studies is somewhat prohibited by a lack of fundamental knowledge. Methods. The study is an anonymized nationwide comprehensive cohort study with nested consented within the mechanism of the British Orthopaedic Surgery Surveillance (BOSS) Study. All relevant hospitals treating SCFE in England, Scotland, and Wales will contribute anonymized case details. Potential missing cases will be cross-checked against two independent external sources of data (the national administrative data and independent trainee data). Patients will be invited to enrich the data collected by supplementing anonymized case data with patient-reported outcome measures. In line with recommendations of the IDEAL Collaboration, the study will primarily seek to determine incidence, describe case mix and variations in surgical interventions, and explore the relationships between baseline factors (patients and types of interventions) and two-year outcomes. Discussion. This is the first disease to be investigated using the BOSS Study infrastructure. It provides a robust method to determine the disease frequency, and a large unbiased sample of cases from which treatment strategies can be investigated. It may form the basis for definitive robust intervention studies or, where these are demonstrated not to be feasible, this may be the most robust cohort study


The Bone & Joint Journal
Vol. 98-B, Issue 11 | Pages 1427 - 1430
1 Nov 2016
Powell JM Rai A Foy M Casey A Dabke H Gibson A Hutton M

Many hospitals do not have a structured process of consent, the attainment of which can often be rather ‘last-minute’ and somewhat chaotic. This is a surprising state of affairs as spinal surgery is a high-risk surgical specialty with potential for expensive litigation claims. More recently, the Montgomery ruling by the United Kingdom Supreme Court has placed the subject of informed consent into the spotlight. . There is a paucity of practical guidance on how a consent process can be achieved in a busy clinical setting. The British Association of Spinal Surgeons (BASS) has convened a working party to address this need. To our knowledge this is the first example of a national professional body, representing a single surgical specialty, taking such a fundamental initiative. . In a hard-pressed clinical environment, the ability to achieve admission reliably on the day of surgery, in patients at ease with their situation and with little likelihood of late cancellation, will be of great benefit. It will reduce litigation and improve the patient experience. Cite this article: Bone Joint J 2016;98-B:1427–30


Bone & Joint Open
Vol. 1, Issue 3 | Pages 41 - 46
18 Mar 2020
Perry DC Arch B Appelbe D Francis P Spowart C Knight M

Introduction. There is widespread variation in the management of rare orthopaedic disease, in a large part owing to uncertainty. No individual surgeon or hospital is typically equipped to amass sufficient numbers of cases to draw robust conclusions from the information available to them. The programme of research will establish the British Orthopaedic Surgery Surveillance (BOSS) Study; a nationwide reporting structure for rare disease in orthopaedic surgery. Methods. The BOSS Study is a series of nationwide observational cohort studies of pre-specified orthopaedic disease. All relevant hospitals treating the disease are invited to contribute anonymised case details. Data will be collected digitally through REDCap, with an additional bespoke software solution used to regularly confirm case ascertainment, prompt follow-up reminders and identify potential missing cases from external sources of information (i.e. national administrative data). With their consent, patients will be invited to enrich the data collected by supplementing anonymised case data with patient reported outcomes. The study will primarily seek to calculate the incidence of the rare diseases under investigation, with 95% confidence intervals. Descriptive statistics will be used to describe the case mix, treatment variations and outcomes. Inferential statistical analysis may be used to analyze associations between presentation factors and outcomes. Types of analyses will be contingent on the disease under investigation. Discussion. This study builds upon other national rare disease supporting structures, particularly those in obstetrics and paediatric surgery. It is particularly focused on addressing the evidence base for quality and safety of surgery, and the design is influenced by the specifications of the IDEAL collaboration for the development of surgical research


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1675 - 1681
1 Dec 2020
Uzoigwe CE O'Leary L Nduka J Sharma D Melling D Simmons D Barton S

Aims. Postoperative delirium (POD) and postoperative cognitive decline (POCD) are common surgical complications. In the UK, the Best Practice Tariff incentivizes the screening of delirium in patients with hip fracture. Further, a National Hip Fracture Database (NHFD) performance indicator is the reduction in the incidence of POD. To aid in its recognition, we sought to determine factors associated with POD and POCD in patients with hip fractures. Methods. We interrogated the NHFD data on patients presenting with hip fractures to our institution from 2016 to 2018. POD was determined using the 4AT score, as recommended by the NHFD and UK Department of Health. POCD was defined as a decline in Abbreviated Mental Test Score (AMTS) of two or greater. Using logistic regression, we adjusted for covariates to identify factors associated with POD and POCD. Results. Of the 1,224 patients presenting in the study period, 1,023 had complete datasets for final analysis. POD was observed in 242 patients (25%). On multivariate analysis only preoperative AMTS and American Society of Anesthesiologists grade (ASA) were independent predictors of POD. Every point increase in AMTS was associated with a fall in the odds of POD by a factor of 0.60 (95% confidence interval (CI) 0.56 to 0.63, p < 0.001). Every grade increase in ASA led to a 1.7-fold increase in the odds of POD (95% CI 1.13 to 2.50, p = 0.009). A preoperative AMTS of less than 8 was strongly predictive of POD with area under the receiver operating characteristic of 0.86 (95% CI 0.84 to 0.89). Only ASA was predictive of POCD—every grade increase in ASA led to a 2.6-fold increase in the odds of POCD (95% CI 1.7 to 4.0, p < 0.001). Conclusion. POD and POCD are common in the hip fracture patients. Preoperative AMTS and ASA are strong predictors of POD, and ASA predictive of POCD. This may aid in the earlier identification of those most at risk and suited for the patient consent and decision-making process. Cite this article: Bone Joint J 2020;102-B(12):1675–1681


Bone & Joint Open
Vol. 1, Issue 6 | Pages 287 - 292
19 Jun 2020
Iliadis AD Eastwood DM Bayliss L Cooper M Gibson A Hargunani R Calder P

Introduction. In response to the COVID-19 pandemic, there was a rapidly implemented restructuring of UK healthcare services. The The Royal National Orthopaedic Hospital, Stanmore, became a central hub for the provision of trauma services for North Central/East London (NCEL) while providing a musculoskeletal tumour service for the south of England, the Midlands, and Wales and an urgent spinal service for London. This study reviews our paediatric practice over this period in order to share our experience and lessons learned. Our hospital admission pathways are described and the safety of surgical and interventional radiological procedures performed under general anaesthesia (GA) with regards to COVID-19 in a paediatric population are evaluated. Methods. All paediatric patients (≤ 16 years) treated in our institution during the six-week peak period of the pandemic were included. Prospective data for all paediatric trauma and urgent elective admissions and retrospective data for all sarcoma admissions were collected. Telephone interviews were conducted with all patients and families to assess COVID-19 related morbidity at 14 days post-discharge. Results. Overall, 100 children underwent surgery or interventional radiological procedures under GA between 20 March and 8 May 2020. There were 35 trauma cases, 20 urgent elective orthopaedic cases, two spinal emergency cases, 25 admissions for interventional radiology procedures, and 18 tumour cases. 78% of trauma cases were performed within 24 hours of referral. In the 97% who responded at two weeks following discharge, there were no cases of symptomatic COVID-19 in any patient or member of their households. Conclusion. Despite the extensive restructuring of services and the widespread concerns over the surgical and anaesthetic management of paediatric patients during this period, we treated 100 asymptomatic patients across different orthopaedic subspecialties without apparent COVID-19 or unexpected respiratory complications in the early postoperative period. The data provides assurance for health care professionals and families and informs the consenting process. Cite this article: Bone Joint Open 2020;1-6:287–292


Bone & Joint Open
Vol. 1, Issue 2 | Pages 3 - 7
5 Feb 2020
Widnall J Capstick T Wijesekera M Messahel S Perry DC

Aims. This study sought to estimate the clinical outcomes and describe the nationwide variation in practice, as part of the feasibility workup for a National Institute for Health and Care Excellence (NICE) recommended randomized clinical trial to determine the optimal treatment of torus fractures of the distal radius in children. Methods. Prospective data collection on torus fractures presenting to our emergency department. Patient consent and study information, including a copy of the Wong-Baker Faces pain score, was issued at the first patient contact. An automated text message service recorded pain scores at days 0, 3, 7, 21, and 42 postinjury. A cross-sectional survey of current accident and emergency practice in the UK was also undertaken to gauge current practice following the publication of NICE guidance. Results. In all, 30 patients with a mean age of 8.9 years were enrolled over a six-week period. Of the 150 potential data points, data was captured in 146, making the data 97.3% complete. Pain scores were recorded at day 0 (mean 6.5 (95% confidence interval (CI) 5.7 to 7.3)), day 3 (4.4 (95% CI 3.5 to 5.2)), day 7 (3.0 (95% CI 2.3 to 3.6)), day 21 (1.2 (95% CI 0.7 to 1.7)) and day 42 (0.4 (95% CI 0.1 to 0.7)). Of the 100 units who participated in the nationwide survey, 38% were unaware of any local or national protocols regarding torus fractures, 41% treated torus fractures with cast immobilization, and over 60% of patients had follow-up arranged, both contradictory to national guidelines. Conclusion. We have demonstrated the severity, recovery trajectory, and variation in pain scores among children with torus fractures. We demonstrate excellent follow-up of patient outcomes using text messages. Despite national guidelines, there is significant variation in practice. This data directly informed the development of an ongoing nationwide randomized clinical trial – the FORearm Fracture Recovery in Children Evaluation (FORCE) study


The Bone & Joint Journal
Vol. 101-B, Issue 7_Supple_C | Pages 40 - 47
1 Jul 2019
Sporer S MacLean L Burger A Moric M

Aims. Our intention was to investigate if the highly porous biological fixation surfaces of a new 3D-printed total knee arthroplasty (TKA) achieved adequate fixation of the tibial and patellar components to the underlying bone. Patients and Methods. A total of 29 patients undergoing primary TKA consented to participate in this prospective cohort study. All patients received a highly porous tibial baseplate and metal-backed patella. Patient-reported outcomes measures were recorded and implant migration was assessed using radiostereometric analysis. Results. Patient function significantly improved by three months postoperatively (p < 0.001). Mean difference in maximum total point motion between 12 and 24 months was 0.021 mm (-0.265 to 0.572) for the tibial implant and 0.089 mm (-0.337 to 0.758) for the patellar implant. The rate of tibial and patellar migration was largest over the first six postoperative weeks, with no changes in mean tibia migration occurring after six months, and no changes in mean patellar migration occurring after six weeks. One patellar component showed a rapid rate of migration between 12 and 24 months. Conclusion. Biological fixation appears to occur reliably on the highly porous implant surface of the tibial baseplate and metal-backed patellar component. Rapid migration after 12 months was measured for one patellar component. Further investigation is required to assess the long-term stability of the 3D-printed components and to determine if the high-migrating components achieve fixation. Cite this article: Bone Joint J 2019;101-B(7 Supple C):40–47


Bone & Joint Research
Vol. 8, Issue 10 | Pages 443 - 450
1 Oct 2019
Treacy RBC Holland JP Daniel J Ziaee H McMinn DJW

Objectives. Modern metal-on-metal (MoM) hip resurfacing arthroplasty (HRA), while achieving good results with well-orientated, well-designed components in ideal patients, is contraindicated in women, men with head size under 50 mm, or metal hypersensitivity. These patients currently have no access to the benefits of HRA. Highly crosslinked polyethylene (XLPE) has demonstrated clinical success in total hip arthroplasty (THA) and, when used in HRA, potentially reduces metal ion-related sequelae. We report the early performance of HRA using a direct-to-bone cementless mono-bloc XLPE component coupled with a cobalt-chrome femoral head, in the patient group for whom HRA is currently contraindicated. Methods. This is a cross-sectional, observational assessment of 88 consecutive metal-on-XLPE HRAs performed in 84 patients between 2015 and 2018 in three centres (three surgeons, including the designer surgeon). Mean follow-up is 1.6 years (0.7 to 3.9). Mean age at operation was 56 years (. sd. 11; 21 to 82), and 73% of implantations were in female patients. All patients were individually counselled, and a detailed informed consent was obtained prior to operation. Primary resurfacing was carried out in 85 hips, and three cases involved revision of previous MoM HRA. Clinical, radiological, and Oxford Hip Score (OHS) assessments were studied, along with implant survival. Results. There was no loss to follow-up and no actual or impending revision or reoperation. Median OHS increased from 24 (interquartile range (IQR) 20 to 28) preoperatively to 48 (IQR 46 to 48) at the latest follow-up (48 being the best possible score). Radiographs showed one patient had a head-neck junction lucency. No other radiolucency, osteolysis, component migration, or femoral neck thinning was noted. Conclusion. The results in this small consecutive cohort suggest that metal-on-monobloc-XLPE HRA is successful in the short term and merits further investigation as a conservative alternative to the current accepted standard of stemmed THA. However, we would stress that survival data with longer-term follow-up are needed prior to widespread adoption. Cite this article: R. B. C. Treacy, J. P. Holland, J. Daniel, H. Ziaee, D. J. W. McMinn. Preliminary report of clinical experience with metal-on-highly-crosslinked-polyethylene hip resurfacing. Bone Joint Res 2019;8:443–450. DOI: 10.1302/2046-3758.810.BJR-2019-0060.R1


Bone & Joint Open
Vol. 5, Issue 6 | Pages 464 - 478
3 Jun 2024
Boon A Barnett E Culliford L Evans R Frost J Hansen-Kaku Z Hollingworth W Johnson E Judge A Marques EMR Metcalfe A Navvuga P Petrie MJ Pike K Wylde V Whitehouse MR Blom AW Matharu GS

Aims

During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing.

Methods

The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group.


Bone & Joint Open
Vol. 5, Issue 3 | Pages 184 - 201
7 Mar 2024
Achten J Marques EMR Pinedo-Villanueva R Whitehouse MR Eardley WGP Costa ML Kearney RS Keene DJ Griffin XL

Aims

Ankle fracture is one of the most common musculoskeletal injuries sustained in the UK. Many patients experience pain and physical impairment, with the consequences of the fracture and its management lasting for several months or even years. The broad aim of ankle fracture treatment is to maintain the alignment of the joint while the fracture heals, and to reduce the risks of problems, such as stiffness. More severe injuries to the ankle are routinely treated surgically. However, even with advances in surgery, there remains a risk of complications; for patients experiencing these, the associated loss of function and quality of life (Qol) is considerable. Non-surgical treatment is an alternative to surgery and involves applying a cast carefully shaped to the patient’s ankle to correct and maintain alignment of the joint with the key benefit being a reduction in the frequency of common complications of surgery. The main potential risk of non-surgical treatment is a loss of alignment with a consequent reduction in ankle function. This study aims to determine whether ankle function, four months after treatment, in patients with unstable ankle fractures treated with close contact casting is not worse than in those treated with surgical intervention, which is the current standard of care.

Methods

This trial is a pragmatic, multicentre, randomized non-inferiority clinical trial with an embedded pilot, and with 12 months clinical follow-up and parallel economic analysis. A surveillance study using routinely collected data will be performed annually to five years post-treatment. Adult patients, aged 60 years and younger, with unstable ankle fractures will be identified in daily trauma meetings and fracture clinics and approached for recruitment prior to their treatment. Treatments will be performed in trauma units across the UK by a wide range of surgeons. Details of the surgical treatment, including how the operation is done, implant choice, and the recovery programme afterwards, will be at the discretion of the treating surgeon. The non-surgical treatment will be close-contact casting performed under anaesthetic, a technique which has gained in popularity since the publication of the Ankle Injury Management (AIM) trial. In all, 890 participants (445 per group) will be randomly allocated to surgical or non-surgical treatment. Data regarding ankle function, QoL, complications, and healthcare-related costs will be collected at eight weeks, four and 12 months, and then annually for five years following treatment. The primary outcome measure is patient-reported ankle function at four months from treatment.


Bone & Joint Open
Vol. 5, Issue 6 | Pages 499 - 513
20 Jun 2024
Keene DJ Achten J Forde C Png ME Grant R Draper K Appelbe D Tutton E Peckham N Dutton SJ Lamb SE Costa ML

Aims

Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures.

Methods

This will be a multicentre, parallel-group, individually randomized controlled superiority trial. We aim to recruit 344 participants aged 50 years and older with an ankle fracture treated surgically or non-surgically from at least 20 NHS hospitals. Participants will be randomized 1:1 using a web-based service to supervised rehabilitation (four to six one-to-one physiotherapy sessions of tailored advice and prescribed home exercise over three months), or self-directed rehabilitation (provision of advice and exercise materials that participants will use to manage their recovery independently). The primary outcome is participant-reported ankle-related symptoms and function six months after randomization, measured by the Olerud and Molander Ankle Score. Secondary outcomes at two, four, and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, complications, and resource use. Due to the nature of the interventions, participants and intervention providers will be unblinded to treatment allocation.


Aims

Olecranon fractures are usually caused by falling directly on to the olecranon or following a fall on to an outstretched arm. Displaced fractures of the olecranon with a stable ulnohumeral joint are commonly managed by open reduction and internal fixation. The current predominant method of management of simple displaced fractures with ulnohumeral stability (Mayo grade IIA) in the UK and internationally is a low-cost technique using tension band wiring. Suture or suture anchor techniques have been described with the aim of reducing the hardware related complications and reoperation. An all-suture technique has been developed to fix the fracture using strong synthetic sutures alone. The aim of this trial is to investigate the clinical and cost-effectiveness of tension suture repair versus traditional tension band wiring for the surgical fixation of Mayo grade IIA fractures of the olecranon.

Methods

SOFFT is a multicentre, pragmatic, two-arm parallel-group, non-inferiority, randomized controlled trial. Participants will be assigned 1:1 to receive either tension suture fixation or tension band wiring. 280 adult participants will be recruited. The primary outcome will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at four months post-randomization. Secondary outcome measures include DASH (at 12, 18, and 24 months), pain, Net Promotor Score (patient satisfaction), EuroQol five-dimension five-level score (EQ-5D-5L), radiological union, complications, elbow range of motion, and re-operations related to the injury or to remove metalwork. An economic evaluation will assess the cost-effectiveness of treatments.


Bone & Joint Open
Vol. 5, Issue 3 | Pages 162 - 173
4 Mar 2024
Di Mascio L Hamborg T Mihaylova B Kassam J Shah B Stuart B Griffin XL

Aims

Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data.

Methods

In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral.


Bone & Joint Open
Vol. 4, Issue 11 | Pages 873 - 880
17 Nov 2023
Swaby L Perry DC Walker K Hind D Mills A Jayasuriya R Totton N Desoysa L Chatters R Young B Sherratt F Latimer N Keetharuth A Kenison L Walters S Gardner A Ahuja S Campbell L Greenwood S Cole A

Aims

Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS).

Methods

UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination.


Bone & Joint Open
Vol. 5, Issue 1 | Pages 69 - 77
25 Jan 2024
Achten J Appelbe D Spoors L Peckham N Kandiyali R Mason J Ferguson D Wright J Wilson N Preston J Moscrop A Costa M Perry DC

Aims

The management of fractures of the medial epicondyle is one of the greatest controversies in paediatric fracture care, with uncertainty concerning the need for surgery. The British Society of Children’s Orthopaedic Surgery prioritized this as their most important research question in paediatric trauma. This is the protocol for a randomized controlled, multicentre, prospective superiority trial of operative fixation versus nonoperative treatment for displaced medial epicondyle fractures: the Surgery or Cast of the EpicoNdyle in Children’s Elbows (SCIENCE) trial.

Methods

Children aged seven to 15 years old inclusive, who have sustained a displaced fracture of the medial epicondyle, are eligible to take part. Baseline function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb score, pain measured using the Wong Baker FACES pain scale, and quality of life (QoL) assessed with the EuroQol five-dimension questionnaire for younger patients (EQ-5D-Y) will be collected. Each patient will be randomly allocated (1:1, stratified using a minimization algorithm by centre and initial elbow dislocation status (i.e. dislocated or not-dislocated at presentation to the emergency department)) to either a regimen of the operative fixation or non-surgical treatment.


Bone & Joint 360
Vol. 13, Issue 6 | Pages 7 - 12
1 Dec 2024
Lawniczak D Holley JM Machin JT Hunter JB Briggs TWR Hutton M