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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. Results. We will conduct a multicentre RCT comparing CSI and HD in combination with CSI alone. Patients aged 18 years and over with a clinical diagnosis of frozen shoulder will be randomized and blinded to receive either CSI and HD in combination, or CSI alone. Feasibility outcomes include the rate of randomization as a proportion of eligible patients and the ability to use routinely collected data for outcome evaluation. This study has involved patients and the public in the trial design, dissemination methods, and how to include groups who are underserved by research. Conclusion. We will disseminate findings among musculoskeletal clinicians via the British Orthopaedic Association, the Chartered Society of Physiotherapy, the Royal College of Radiologists, and the Royal College of General Practitioners. To ensure wide reach we will communicate findings through our established network of charities and organizations, in addition to preparing dissemination findings in Bangla and Urdu (commonly spoken languages in northeast London). If a full trial is shown to be feasible, we will seek additional National Institute for Health and Care Research funding for a definitive RCT. This definitive study will inform NICE guidelines for the management of frozen shoulder. Cite this article: Bone Jt Open 2024;5(3):162–173


Bone & Joint Open
Vol. 5, Issue 7 | Pages 534 - 542
1 Jul 2024
Woods A Howard A Peckham N Rombach I Saleh A Achten J Appelbe D Thamattore P Gwilym SE

Aims. The primary aim of this study was to assess the feasibility of recruiting and retaining patients to a patient-blinded randomized controlled trial comparing corticosteroid injection (CSI) to autologous protein solution (APS) injection for the treatment of subacromial shoulder pain in a community care setting. The study focused on recruitment rates and retention of participants throughout, and collected data on the interventions’ safety and efficacy. Methods. Participants were recruited from two community musculoskeletal treatment centres in the UK. Patients were eligible if aged 18 years or older, and had a clinical diagnosis of subacromial impingement syndrome which the treating clinician thought was suitable for treatment with a subacromial injection. Consenting patients were randomly allocated 1:1 to a patient-blinded subacromial injection of CSI (standard care) or APS. The primary outcome measures of this study relate to rates of recruitment, retention, and compliance with intervention and follow-up to determine feasibility. Secondary outcome measures relate to the safety and efficacy of the interventions. Results. A total of 53 patients were deemed eligible, and 50 patients (94%) recruited between April 2022 and October 2022. Overall, 49 patients (98%) complied with treatment. Outcome data were collected in 100% of participants at three months and 94% at six months. There were no significant adverse events. Both groups demonstrated improvement in patient-reported outcome measures over the six-month period. Conclusion. Our study shows that it is feasible to recruit to a patient-blinded randomized controlled trial comparing APS and CSI for subacromial pain in terms of clinical outcomes and health-resource use in the UK. Safety and efficacy data are presented. Cite this article: Bone Jt Open 2024;5(7):534–542


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 34 - 34
1 Nov 2021
Larsen JB Østergaard HK Thillemann TM Falstie-Jensen T Reimer L Noe S Jensen SL Mechlenburg I
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Introduction and Objective. Only few studies have investigated the outcome of exercises in patients with glenohumeral osteoarthritis (OA) or rotator cuff tear arthropathy (CTA), and furthermore often excluded patients with a severe degree of OA. Several studies including a Cochrane review have suggested the need for trials comparing shoulder arthroplasty to non-surgical treatments. Before initiation of such a trial, the feasibility of progressive shoulder exercises (PSE) in patients, who are eligible for shoulder arthroplasty should be investigated. The aim was to investigate whether 12 weeks of PSE is feasible in patients with OA or CTA eligible for shoulder arthroplasty. Moreover, to report changes in shoulder function and range of motion (ROM) following the exercise program. Materials and Methods. Eighteen patients (11 women, 14 OA), mean age 70 years (range 57–80), performed 12 weeks of PSE with 1 weekly physiotherapist-supervised and 2 weekly home-based sessions. Feasibility was measured by drop-out rate, adverse events, pain and adherence to PSE. Patients completed Western Ontario Osteoarthritis of the Shoulder (WOOS) score and Disabilities of the Arm, Shoulder and Hand (DASH). Results. Two patients dropped out and no adverse events were observed. Sixteen patients (89%) had high adherence to the physiotherapist-supervised sessions. Acceptable pain levels were reported. WOOS improved mean 23 points (95%CI:13;33), and DASH improved mean 13 points (95%CI:6;19). Conclusions. PSE is feasible, safe and may improve shoulder pain, function and ROM in patients with OA or CTA eligible for shoulder arthroplasty. PSE is a feasible treatment that may be compared with arthroplasty in a RCT setting


Bone & Joint Open
Vol. 5, Issue 8 | Pages 671 - 680
14 Aug 2024
Fontalis A Zhao B Putzeys P Mancino F Zhang S Vanspauwen T Glod F Plastow R Mazomenos E Haddad FS

Aims. Precise implant positioning, tailored to individual spinopelvic biomechanics and phenotype, is paramount for stability in total hip arthroplasty (THA). Despite a few studies on instability prediction, there is a notable gap in research utilizing artificial intelligence (AI). The objective of our pilot study was to evaluate the feasibility of developing an AI algorithm tailored to individual spinopelvic mechanics and patient phenotype for predicting impingement. Methods. This international, multicentre prospective cohort study across two centres encompassed 157 adults undergoing primary robotic arm-assisted THA. Impingement during specific flexion and extension stances was identified using the virtual range of motion (ROM) tool of the robotic software. The primary AI model, the Light Gradient-Boosting Machine (LGBM), used tabular data to predict impingement presence, direction (flexion or extension), and type. A secondary model integrating tabular data with plain anteroposterior pelvis radiographs was evaluated to assess for any potential enhancement in prediction accuracy. Results. We identified nine predictors from an analysis of baseline spinopelvic characteristics and surgical planning parameters. Using fivefold cross-validation, the LGBM achieved 70.2% impingement prediction accuracy. With impingement data, the LGBM estimated direction with 85% accuracy, while the support vector machine (SVM) determined impingement type with 72.9% accuracy. After integrating imaging data with a multilayer perceptron (tabular) and a convolutional neural network (radiograph), the LGBM’s prediction was 68.1%. Both combined and LGBM-only had similar impingement direction prediction rates (around 84.5%). Conclusion. This study is a pioneering effort in leveraging AI for impingement prediction in THA, utilizing a comprehensive, real-world clinical dataset. Our machine-learning algorithm demonstrated promising accuracy in predicting impingement, its type, and direction. While the addition of imaging data to our deep-learning algorithm did not boost accuracy, the potential for refined annotations, such as landmark markings, offers avenues for future enhancement. Prior to clinical integration, external validation and larger-scale testing of this algorithm are essential. Cite this article: Bone Jt Open 2024;5(8):671–680


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 44 - 44
1 Oct 2022
Hebberd B Rooke C Burton K
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Purpose. The purpose of this study was to discover if student led clinics (SLC) are feasible delivery mechanisms for Low back pain (LBP) self-management support and to develop a service model. Background. LBP is the most commonly reported musculoskeletal disorder worldwide. The increasing service and workforce demands of LBP are challenging for providers and policy makers. self-management is appropriate for many people living with LBP yet guidance for self-management is lacking. One potential delivery mechanism is through SLC. These are ‘clinics’ run by students, supervised by clinicians. Methods and Results. A scoping review has found that SLC can be effective for supporting self-management of various long-term conditions and can provide cost benefits compared with traditional clinical services. In principle, their use for providing LBP services could have similar advantages as well as mitigating the clinical placement shortage. A further scoping review of self-management support for LBP was used to develop a model for student-led LBP clinics. The proposed model is a student led LBP supported self-management service. The service users will be triaged using the Psychosocial Flags Framework to identify obstacles to participation, followed by 1–6 sessions of self-management support comprising of; 1) empathetic listening and education to build a therapeutic relationship and to dispel LBP myths; 2) collaboratively setting meaningful goals; 3) imparting knowledge and skills to overcome the identified obstacles; 4) developing an evidence-informed plan for self-management, agreed with relevant stakeholders. Conclusion. Previous experience and the evidence-base suggest that SLC are feasible for delivering self-management support for LBP. Conflicts of interest: No conflicts of interest. Sources of funding: No funding obtained


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_5 | Pages 42 - 42
1 Apr 2022
Guichet J Chekairi A Stride M
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Introduction. The Patient's Dream is not to stay in hospital even overnight, including in limb lengthening. We developed the ‘Hyper Fast Track Protocol’ (HFTP) in 2015 to fasten recovery and shorten hospital stay. Materials and Methods. The protocol included surgical stab incisions, use of weight bearing lengthening nails (G-Nail), intramedullary saw, a specific anaesthesia care (blood hypo-pressure, tranexamic acid, low hydration), absence of early anticoagulants, systematic vascular US controls, but early motion (hip and knee Ext/Fle, leg raise, horizontal ‘scissors’), walking, stairs, bike, clicking (maneuvers to lengthen), early discharge, along with other patient's parameters. Timing and exercises reps were registered. Protocols improved over time. Means ± SD are computed. Results. Forms were analysed in 112 patients (unilateral 7, dwarfism 2, cosmetic 103). Besides patients operated in the afternoon (18), physio sessions initiated (h:mm) in average 0:46 ± 0:19 after awakening in operative room, for a duration of 2:15 ± 0:46. No DVT was noted on US nor clinically. In 2016, hospitalisation averaged 2.88 nights, decreasing to 2.07 in 2017, then to 1.07 from 2020. In late 2020 and in 2021, we had several patients in Daycare only, even in bilateral lengthening. In late 2021, we could discharge a patient after walking, full motion and exercises 3.5 hours after awakening from bilateral surgery. Conclusions. With continuous result monitoring and constant improvement of Care, walking, stairs, clicks and biking are fully feasible within 3h of surgery awakening, with discharge on the same day, using specific protocols


Bone & Joint Research
Vol. 13, Issue 9 | Pages 513 - 524
19 Sep 2024
Kalsoum R Minns Lowe CJ Gilbert S McCaskie AW Snow M Wright K Bruce G Mason DJ Watt FE

Aims. To explore key stakeholder views around feasibility and acceptability of trials seeking to prevent post-traumatic osteoarthritis (PTOA) following knee injury, and provide guidance for next steps in PTOA trial design. Methods. Healthcare professionals, clinicians, and/or researchers (HCP/Rs) were surveyed, and the data were presented at a congress workshop. A second and related survey was then developed for people with joint damage caused by knee injury and/or osteoarthritis (PJDs), who were approached by a UK Charity newsletter or Oxford involvement registry. Anonymized data were collected and analyzed in Qualtrics. Results. Survey responses (n = 19 HCP/Rs, 39 PJDs) supported studies testing pharmacological agents preventing PTOA. All HCP/Rs and 30/31 (97%) PJDs supported the development of new treatments that improved or delayed knee symptoms and damage to knee structure. PJDs thought that improving structural knee damage was more important than knee symptoms. Both groups found studies more acceptable as expected future benefit and risk of PTOA increased. All drug delivery routes were acceptable. Workshop participants (around n = 60) reflected survey views. Discussions suggested that stratifying using molecular testing for likely drug response appeared to be more acceptable than using characteristics such as sex, age, and BMI. Conclusion. Our findings supported PTOA drug intervention studies, including situations where there is low risk of disease, no expected benefit of treatment, and frequent treatment administration. PJDs appeared less risk-averse than HCP/Rs. This work reinforces the benefits of consensus and involvement work in the co-creation of PTOA drug trial design. Involvement of key stakeholders, such as PJDs with different risks of OA and regulatory representatives, are critical for trial design success. Cite this article: Bone Joint Res 2024;13(9):513–524


Bone & Joint Open
Vol. 3, Issue 4 | Pages 302 - 306
4 Apr 2022
Mayne AIW Cassidy RS Magill P Mockford BJ Acton DA McAlinden MG

Aims. Waiting times for arthroplasty surgery in Northern Ireland are among the longest in the NHS, which have been further lengthened by the onset of the COVID-19 global pandemic in March 2020. The Department of Health in Northern Ireland has announced a new Elective Care Framework (ECF), with the framework proposing that by March 2026 no patient will wait more than 52 weeks for inpatient/day case treatment. We aimed to assess the feasibility of achieving this with reference to total hip arthroplasty (THA) and total knee arthroplasty (TKA). Methods. Mathematical modelling was undertaken to calculate when the ECF targets will be achieved for THA and TKA, as well as the time when waiting lists for THA and TKA will be cleared. The number of patients currently on the waiting list and percentage operating capacity relative to pre-COVID-19 capacity was used to determine future projections. Results. As of May 2021, there were 3,757 patients awaiting primary THA and 4,469 patients awaiting primary TKA in Northern Ireland. Prior to April 2020, there were a mean 2,346 (2,085 to 2,610) patients per annum boarded for primary THA, a mean 2,514 (2,494 to 2,514) patients per annum boarded for primary TKA, and there were a mean 1,554 primary THAs and 1,518 primary TKAs performed per annum. The ECF targets for THA will only be achieved in 2030 if operating capacity is 200% of pre COVID-19 pandemic capacity and in 2042 if capacity is 170%. For TKA, the targets will be met in 2034 if capacity is 200% of pre-COVID-19 pandemic capacity. Conclusion. This modelling demonstrates that, in the absence of major funding and reorganization of elective orthopaedic care, the targets set out in the ECF will not be achieved with regard to THA and TKA. Waiting times for THA and TKA surgery in Northern Ireland are likely to remain greater than 52 weeks for most of this decade. Cite this article: Bone Jt Open 2022;3(4):302–306


Bone & Joint Open
Vol. 2, Issue 11 | Pages 909 - 920
10 Nov 2021
Smith T Clark L Khoury R Man M Hanson S Welsh A Clark A Hopewell S Pfeiffer K Logan P Crotty M Costa M Lamb SE

Aims. This study aims to assess the feasibility of conducting a pragmatic, multicentre randomized controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery. Methods. This will be a mixed-methods feasibility RCT, recruiting 60 patients following hip fracture surgery and their informal caregivers. Patients will be randomized to usual NHS care, versus usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme will comprise of three, one-hour, one-to-one training sessions for the patient and caregiver, delivered by a nurse, physiotherapist, or occupational therapist. Training will be delivered in the hospital setting pre-patient discharge. It will include practical skills for rehabilitation such as: transfers and walking; recovery goal setting and expectations; pacing and stress management techniques; and introduction to the HIP HELPER Caregiver Workbook, which provides information on recovery, exercises, worksheets, and goal-setting plans to facilitate a ‘good’ recovery. After discharge, patients and caregivers will be supported in delivering rehabilitation through three telephone coaching sessions. Data, collected at baseline and four months post-randomization, will include: screening logs, intervention logs, fidelity checklists, quality assurance monitoring visit data, and clinical outcomes assessing quality of life, physical, emotional, adverse events, and resource use outcomes. The acceptability of the study intervention and RCT design will be explored through qualitative methods with 20 participants (patients and informal caregivers) and 12 health professionals. Discussion. A multicentre recruitment approach will provide greater external validity across population characteristics in England. The mixed-methods approach will permit in-depth examination of the intervention and trial design parameters. The findings will inform whether and how a definitive trial may be undertaken to test the effectiveness of this caregiver intervention for patients after hip fracture surgery. Cite this article: Bone Jt Open 2021;2(11):909–920


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 48 - 48
1 Dec 2022
Yee N Iorio C Shkumat N Rocos B Ertl-Wagner B Green A Lebel D Camp M
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Neuromuscular scoliosis patients face rates of major complications of up to 49%. Along with pre-operative risk reduction strategies (including nutritional and bone health optimization), intra-operative strategies to decrease blood loss and decrease surgical time may help mitigate these risks. A major contributor to blood loss and surgical time is the insertion of instrumentation which is challenging in neuromuscular patient given their abnormal vertebral and pelvic anatomy. Standard pre-operative radiographs provide minimal information regarding pedicle diameter, length, blocks to pedicle entry (e.g. iliac crest overhang), or iliac crest orientation. To minimize blood loss and surgical time, we developed an “ultra-low dose” CT protocol without sedation for neuromuscular patients. Our prospective quality improvement study aimed to determine: if ultra-low dose CT without sedation was feasible given the movement disorders in this population; what the radiation exposure was compared to standard pre-operative imaging; whether the images allowed accurate assessment of the anatomy and intra-operative navigation given the ultra-low dose and potential movement during the scan. Fifteen non-ambulatory surgical patients with neuromuscular scoliosis received the standard spine XR and an ultra-low dose CT scan. Charts were reviewed for etiology of neuromuscular scoliosis and medical co-morbidities. The CT protocol was a high-speed, high-pitch, tube-current modulated acquisition at a fixed tube voltage. Adaptive statistical iterative reconstruction was applied to soft-tissue and bone kernels to mitigate noise. Radiation dose was quantified using reported dose indices (computed tomography dose index (CTDIvol) and dose-length product (DLP)) and effective dose (E), calculated through Monte-Carlo simulation. Statistical analysis was completed using a paired student's T-test (α = 0.05). CT image quality was assessed for its use in preoperative planning and intraoperative navigation using 7D Surgical System Spine Module (7D Surgical, Toronto, Canada). Eight males and seven females were included in the study. Their average age (14±2 years old), preoperative Cobb angle (95±21 degrees), and kyphosis (60±18 degrees) were recorded. One patient was unable to undergo the ultra-low dose CT protocol without sedation due to a co-diagnosis of severe autism. The average XR radiation dose was 0.5±0.3 mSv. Variability in radiographic dose was due to a wide range in patient size, positioning (supine, sitting), number of views, imaging technique and body habitus. Associated CT radiation metrics were CTDIvol = 0.46±0.14 mGy, DLP = 26.2±8.1 mGy.cm and E = 0.6±0.2 mSv. CT radiation variability was due to body habitus and arm orientation. The radiation dose differences between radiographic and CT imaging were not statistically significant. All CT scans had adequate quality for preoperative assessment of pedicle diameter and orientation, obstacles impeding pedicle entry, S2-Alar screw orientation, and intra-operative navigation. “Ultra-low dose” CT scans without sedation were feasible in paediatric patients with neuromuscular scoliosis. The effective dose was similar between the standard preoperative spinal XR and “ultra-low dose” CT scans. The “ultra-low dose” CT scan allowed accurate assessment of the anatomy, aided in pre-operative planning, and allowed intra-operative navigation despite the movement disorders in this patient population


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 68 - 68
1 Dec 2022
Yee N Lorio C Shkumat N Rocos B Ertl-Wagner B Green A Lebel D Camp M
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Neuromuscular scoliosis patients face rates of major complications of up to 49%. Along with pre-operative risk reduction strategies (including nutritional and bone health optimization), intra-operative strategies to decrease blood loss and decrease surgical time may help mitigate these risks. A major contributor to blood loss and surgical time is the insertion of instrumentation which is challenging in neuromuscular patient given their abnormal vertebral and pelvic anatomy. Standard pre-operative radiographs provide minimal information regarding pedicle diameter, length, blocks to pedicle entry (e.g. iliac crest overhang), or iliac crest orientation. To minimize blood loss and surgical time, we developed an “ultra-low dose” CT protocol without sedation for neuromuscular patients. Our prospective quality improvement study aimed to determine:. if ultra-low dose CT without sedation was feasible given the movement disorders in this population;. what the radiation exposure was compared to standard pre-operative imaging;. whether the images allowed accurate assessment of the anatomy and intra-operative navigation given the ultra-low dose and potential movement during the scan. Fifteen non-ambulatory surgical patients with neuromuscular scoliosis received the standard spine XR and an ultra-low dose CT scan. Charts were reviewed for etiology of neuromuscular scoliosis and medical co-morbidities. The CT protocol was a high-speed, high-pitch, tube-current modulated acquisition at a fixed tube voltage. Adaptive statistical iterative reconstruction was applied to soft-tissue and bone kernels to mitigate noise. Radiation dose was quantified using reported dose indices (computed tomography dose index (CTDIvol) and dose-length product (DLP)) and effective dose (E), calculated through Monte-Carlo simulation. Statistical analysis was completed using a paired student's T-test (α= 0.05). CT image quality was assessed for its use in preoperative planning and intraoperative navigation using 7D Surgical System Spine Module (7D Surgical, Toronto, Canada). Eight males and seven females were included in the study. Their average age (14±2 years old), preoperative Cobb angle (95±21 degrees), and kyphosis (60±18 degrees) were recorded. One patient was unable to undergo the ultra-low dose CT protocol without sedation due to a co-diagnosis of severe autism. The average XR radiation dose was 0.5±0.3 mSv. Variability in radiographic dose was due to a wide range in patient size, positioning (supine, sitting), number of views, imaging technique and body habitus. Associated CT radiation metrics were CTDIvol = 0.46±0.14 mGy, DLP = 26.2±8.1 mGy.cm and E = 0.6±0.2 mSv. CT radiation variability was due to body habitus and arm orientation. The radiation dose differences between radiographic and CT imaging were not statistically significant. All CT scans had adequate quality for preoperative assessment of pedicle diameter and orientation, obstacles impeding pedicle entry, S2-Alar screw orientation, and intra-operative navigation. “Ultra-low dose” CT scans without sedation were feasible in paediatric patients with neuromuscular scoliosis. The effective dose was similar between the standard preoperative spinal XR and “ultra-low dose” CT scans. The “ultra-low dose” CT scan allowed accurate assessment of the anatomy, aided in pre-operative planning, and allowed intra-operative navigation despite the movement disorders in this patient population


Bone & Joint Research
Vol. 2, Issue 2 | Pages 33 - 40
1 Feb 2013
Palmer AJR Thomas GER Pollard TCB Rombach I Taylor A Arden N Beard DJ Andrade AJ Carr AJ Glyn-Jones S

Objectives. The number of surgical procedures performed each year to treat femoroacetabular impingement (FAI) continues to rise. Although there is evidence that surgery can improve symptoms in the short-term, there is no evidence that it slows the development of osteoarthritis (OA). We performed a feasibility study to determine whether patient and surgeon opinion was permissive for a Randomised Controlled Trial (RCT) comparing operative with non-operative treatment for FAI. Methods. Surgeon opinion was obtained using validated questionnaires at a Specialist Hip Meeting (n = 61, 30 of whom stated that they routinely performed FAI surgery) and patient opinion was obtained from clinical patients with a new diagnosis of FAI (n = 31). Results. Clinical equipoise was demonstrated when surgeons were given clinical scenarios and asked whether they would manage a patient operatively or non-operatively. A total of 23 surgeons (77%) who routinely perform FAI surgery were willing to recruit patients into a RCT, and 28 patients (90%) were willing to participate. 75% of responding surgeons believed it was appropriate to randomise patients to non-operative treatment for ≥ 12 months. Conversely, only eight patients (26%) felt this was acceptable, although 29 (94%) were willing to continue non-operative treatment for six months. More patients were concerned about their risk of developing OA than their current symptoms, although most patients felt that the two were of equal importance. Conclusions. We conclude that a RCT comparing operative and non-operative management of FAI is feasible and should be considered a research priority. An important finding for orthopaedic surgical trials is that patients without life-threatening pathology appear willing to trial a treatment for six months without improvement in their symptoms


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_14 | Pages 43 - 43
1 Nov 2018
Beswick AD Strange S Mallon C Lenguerrand E Moore AJ Kunutsor SK Whitehouse MR Porteous A Toms A Blom AW
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Patients with knee prosthetic joint infection (PJI) frequently receive one- or two-stage revision. To explore the feasibility of a randomised controlled trial (RCT) comparing methods, we analysed a UK registry, interviewed patients and surgeons, systematically reviewed literature, held a consensus meeting, and assessed progress of an RCT in hip PJI. In 2014, in England and Wales, knee PJI was treated with one- or two-stage procedures in 19% and 71% of patients respectively. Between 2007 and 2014, use of one-stage procedures doubled and, in major centres, up to 42% of treatments were one-stage. We conducted in-depth interviews with 16 patients with knee PJI and 11 surgeons performing one- or two-stage revision. Patients considered randomisation acceptable with appropriate counselling and, depending on infecting organisms and health status, surgeons would randomise treatments. In meta-analysis, two-year re-infection rates in 10 one-stage series (423 patients) and 108 two-stage series (5,129 patients) were 7.6% (95%CI 3.4,13.1) and 8.8% (7.2,10.6) respectively. In a series of patients with knee PJI, surgeons from 2 major centres considered 6/15 patients eligible for either treatment, with 4 more potentially eligible after treatment of soft tissue infection. In an ongoing RCT of surgical treatment of hip PJI, 116 patients have been randomised at 14 centres in 3 years. Randomising patients with PJI is feasible but, as knee PJI is uncommon, a multicentre RCT would be required. Based on WOMAC score outcome and appropriate assumptions on eligibility and acceptability, 170 patients would need to be randomised over 4 years at 14 major centres


Bone & Joint Research
Vol. 4, Issue 5 | Pages 78 - 83
1 May 2015
Martinkevich P Rahbek O Møller-Madsen B Søballe K Stilling M

Objectives

Lengthening osteotomies of the calcaneus in children are in general grafted with bone from the iliac crest. Artificial bone grafts have been introduced, however, their structural and clinical durability has not been documented. Radiostereometric analysis (RSA) is a very accurate and precise method for measurements of rigid body movements including the evaluation of joint implant and fracture stability, however, RSA has not previously been used in clinical studies of calcaneal osteotomies. We assessed the precision of RSA as a measurement tool in a lateral calcaneal lengthening osteotomy (LCLO).

Methods

LCLO was performed in six fixed adult cadaver feet. Tantalum markers were inserted on each side of the osteotomy and in the cuboideum. Lengthening was done with a plexiglas wedge. A total of 24 radiological double examinations were obtained. Two feet were excluded due to loose and poorly dispersed markers. Precision was assessed as systematic bias and 95% repeatability limits.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_27 | Pages 12 - 12
1 Jul 2013
Logishetty K Cope A Ferguson J Alvand A Price A Rees J
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Introduction

Current work-hour restrictions and cost pressures have highlighted the limitations of apprenticeship-based learning, and led to the development of alternative methods to improve the skills of orthopaedic trainees outside of the clinical environment. These methods include using synthetic bones and simulators in the laboratory setting. Educational theory highlights the importance of context for effective learning, yet full-immersion simulation facilities are prohibitively expensive. This study explored the concept of contextualised training day in trauma & orthopaedics.

Methods

Fifteen novice surgeons provided feedback after completing three teaching modules:

OSCE-style Problem-based Learning of Orthopaedic Trauma in the Fracture Clinic Setting, utilising an actor and radiographs to teach history, examination, diagnostic and management skills

The positioning, preparing and draping of a patient, and Examination under anaesthesia (EUA) for arthroscopic knee surgery, utilising an operating table and theatre equipment to teach procedural and examination skills

Simulator based training for diagnostic shoulder and knee arthroscopy; and Bankart repair, utilising arthroscopic stack and synthetic joint models to develop arthroscopic motor skill and procedural knowledge


Rapid discharge pathways (RDP) have been implemented throughout most areas of orthopaedics. The primary goal of these pathways is to standardize the post-surgical hospital course for patients in order to decrease hospital length-of-stay (LOS). Surgical treatment of adolescent idiopathic scoliosis (AIS) remains one of the most invasive pediatric orthopaedic procedure and is routinely associated with a prolonged hospital stay. The implementation of RDPs following surgery for AIS has shown to be successful; however, all of these studies have been conducted within the United States and it has been shown previously that there exists major differences in hospital LOS and in post-operative complications between Canada and the United States. Therefore, the objective of this study was to determine if the implementation of a RDP at a single children's tertiary-referral centre in Canada could decrease hospital LOS without increasing post-operative complications.

A retrospective chart review was completed for all patients who underwent posterior spinal instrumentation and fusion (PSIF) between March 1st, 2010 and February 28th, 2019, with date of implementation being March 1st, 2015. Patient pre-operative, operative, and post-operative information was collected from the charts along with the primary outcome variables: LOS, wound complication, 30-day return to the OR, 30-day emergency department admission, and 30-day hospital readmission. An interrupted time series analysis with a robust linear regression model was utilized to assess for any differences in outcomes following implementation of the RDP. Ninety days before and after the implementation of the RDP was not included in this analysis due to variances in practice that were occurring at this time.

A total of 244 participants were identified, with 113 patients in the conventional pathway and 131 patients in the RDP cohort. No significant differences in pre-operative or operative characteristics existed between the groups, except for the RDP group having approximately a 50 larger pre-operative curve and the conventional pathway having on average 200mL greater intra-operative blood loss (p<0.05). Hospital LOS was found to be significantly shorter in the RDP group, with the median LOS being 5.2 [95% IQR 4.3–6.1] days in the conventional group and 3.4 [95% IQR 3.3–3.5] days in the RDP group (p<0.05). Patients in the RDP group were also found to stand 0.9 days earlier, walk 1.1 days earlier, their Foley catheter was discontinued 0.5 days earlier and their personal controlled analgesia was discontinued 12 hours sooner (p<0.05). There were no differences in post-operative complications between the two groups (p>0.05).

This study demonstrates that implementing a RDP following PSIF for AIS can successfully decrease hospital LOS without increasing post-operative complications in a single payer universal healthcare system. The associated decrease in LOS could correlate with decreasing costs for both the healthcare system and for the patient's family.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 35 - 35
7 Aug 2024
Alotibi FS Hendrick P Moffatt F
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Background. Immersive virtual reality (VR) demonstrates potential benefits in patients with chronic low back pain (CLBP). However, few studies have investigated the feasibility and the acceptability of introducing immersive VR for use with patients with CLBP and in the Kingdom of Saudi Arabia (KSA). Aim. To investigate immersive VR's feasibility, tolerability, and acceptability as a rehabilitation intervention for adult patients with CLBP and explore the views of relevant Health Care Practitioners (HCPs) in the KSA. Methodology and Methods. A multi-centre, mixed-methods, explanatory sequential design was adopted to test immersive VR's feasibility, tolerability, and acceptability. An uncontrolled feasibility trial was conducted. The immersive VR intervention involved a training session followed by three sessions over one week using commercially available hardware and software. Feasibility outcomes were collected from patients immediately post-intervention. Patients and HCPs were recruited for semi-structured interviews. Results. Thirty-three patients and three HCPs were recruited. The feasibility a priori criteria were met for recruitment, retention, dropout, completeness of questionnaire data, treatment compliance and fidelity. Adverse events included one who reported aggravation of tinnitus, whereas two experienced dizziness. Qualitative data suggested that entertainment and motivation were key enablers. Barriers included technological capability and HCPs’ perceptions that immersive VR was time-consuming. Conclusion. The results suggested that immersive VR was feasible, acceptable, and tolerable among patients with CLBP and HCPs in clinical settings in the KSA. Further research focusing on the effectiveness is warranted in this field. Conflicts of Interest. None. Sources of Funding. None. Trial registration number. ISRCTN14434517


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 28 - 28
7 Aug 2023
Bertram W Wylde V Glynn J Penfold C Burston A Johnson E Rayment D Howells N White S Gooberman-Hill R Whale K
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Abstract. Introduction. There is a need to develop approaches to reduce chronic pain after total knee replacement. There is an established link between disturbed sleep and pain. We tested the feasibility of a trial evaluating the clinical and cost-effectiveness of a pre-operative sleep assessment and complex intervention package for improving long-term pain after TKR. Methodology. REST was a feasibility multi-centre randomised controlled trial with embedded qualitative study and health economics. Participants completed baseline measures and were randomised to usual care or the intervention, a tailored sleep assessment and behavioural intervention package delivered by an extended scope practitioner three months pre-operatively with a follow-up call up at four-weeks. Patient reported outcomes were assessed at baseline, one-week pre-surgery, and 3-months post-surgery. Results. 57 patients were randomised and 20 had surgery within the study timelines. All patients allocated the intervention attended an appointment and most engaged with treatment. The intervention group reported improvements in sleep (Sleep Conditions Indicator) and neuropathic pain (painDETECT) scores. Participants found the sleep treatments and study processes to be acceptable. The mean cost of the intervention was estimated at £134.45 per patient. Conclusion. The feasibility study has shown that patient recruitment is feasible, engagement with and adherence to the intervention is high, and the intervention is acceptable to patients and clinicians. Preliminary findings show that the intervention group had improved sleep quality and had reduced levels of pre-operative neuropathic pain. This study has demonstrated that a full RCT is feasible and identified areas for improvement to optimize the trial design


Bone & Joint Open
Vol. 5, Issue 1 | Pages 46 - 52
19 Jan 2024
Assink N ten Duis K de Vries JPM Witjes MJH Kraeima J Doornberg JN IJpma FFA

Aims. Proper preoperative planning benefits fracture reduction, fixation, and stability in tibial plateau fracture surgery. We developed and clinically implemented a novel workflow for 3D surgical planning including patient-specific drilling guides in tibial plateau fracture surgery. Methods. A prospective feasibility study was performed in which consecutive tibial plateau fracture patients were treated with 3D surgical planning, including patient-specific drilling guides applied to standard off-the-shelf plates. A postoperative CT scan was obtained to assess whether the screw directions, screw lengths, and plate position were performed according the preoperative planning. Quality of the fracture reduction was assessed by measuring residual intra-articular incongruence (maximum gap and step-off) and compared to a historical matched control group. Results. A total of 15 patients were treated with 3D surgical planning in which 83 screws were placed by using drilling guides. The median deviation of the achieved screw trajectory from the planned trajectory was 3.4° (interquartile range (IQR) 2.5 to 5.4) and the difference in entry points (i.e. plate position) was 3.0 mm (IQR 2.0 to 5.5) compared to the 3D preoperative planning. The length of 72 screws (86.7%) were according to the planning. Compared to the historical cohort, 3D-guided surgery showed an improved surgical reduction in terms of median gap (3.1 vs 4.7 mm; p = 0.126) and step-off (2.9 vs 4.0 mm; p = 0.026). Conclusion. The use of 3D surgical planning including drilling guides was feasible, and facilitated accurate screw directions, screw lengths, and plate positioning. Moreover, the personalized approach improved fracture reduction as compared to a historical cohort. Cite this article: Bone Jt Open 2024;5(1):46–52


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1408 - 1415
1 Dec 2024
Wall L Bunzli S Nelson E Hawke LJ Genie M Hinwood M Lang D Dowsey MM Clarke P Choong PF Balogh ZJ Lohmander LS Paolucci F

Aims. Surgeon and patient reluctance to participate are potential significant barriers to conducting placebo-controlled trials of orthopaedic surgery. Understanding the preferences of orthopaedic surgeons and patients regarding the design of randomized placebo-controlled trials (RCT-Ps) of knee procedures can help to identify what RCT-P features will lead to the greatest participation. This information could inform future trial designs and feasibility assessments. Methods. This study used two discrete choice experiments (DCEs) to determine which features of RCT-Ps of knee procedures influence surgeon and patient participation. A mixed-methods approach informed the DCE development. The DCEs were analyzed with a baseline category multinomial logit model. Results. The proportion of respondents (surgeons n = 103; patients n = 140) who would not participate in any of the DCE choice sets (surgeons = 31%; patients = 40%), and the proportion who would participate in all (surgeons = 18%; patients = 30%), indicated strong views regarding the conduct of RCT-Ps. There were three main findings: for both surgeons and patients, studies which involved an arthroscopic procedure were more likely to result in participation than those with a total knee arthroplasty; as the age (for patients) and years of experience (for surgeons) increased, the overall likelihood of participation decreased; and, for surgeons, offering authorship and input into the RCT-P design was preferred for less experienced surgeons, while only completing the procedure was preferred by more experienced surgeons. Conclusion. Patients and surgeons have strong views regarding participation in RCT-Ps. However, understanding their preferences can inform future trial designs and feasibility assessments with regard to recruitment rates. Cite this article: Bone Joint J 2024;106-B(12):1408–1415