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Bone & Joint Open
Vol. 5, Issue 11 | Pages 1037 - 1040
15 Nov 2024
Wu DY Lam EKF

Aims. The first metatarsal pronation deformity of hallux valgus feet is widely recognized. However, its assessment relies mostly on 3D standing CT scans. Two radiological signs, the first metatarsal round head (RH) and inferior tuberosity position (ITP), have been described, but are seldom used to aid in diagnosis. This study was undertaken to determine the reliability and validity of these two signs for a more convenient and affordable preoperative assessment and postoperative comparison. Methods. A total of 200 feet were randomly selected from the radiograph archives of a foot and ankle clinic. An anteroposterior view of both feet was taken while standing on the same x-ray platform. The intermetatarsal angle (IMA), metatarsophalangeal angle (MPA), medial sesamoid position, RH, and ITP signs were assessed for statistical analysis. Results. There were 127 feet with an IMA > 9°. Both RH and ITP severities correlated significantly with IMA severity. RH and ITP were also significantly associated with each other, and the pronation deformities of these feet are probably related to extrinsic factors. There were also feet with discrepancies between their RH and ITP severities, possibly due to intrinsic torsion of the first metatarsal. Conclusion. Both RH and ITP are reliable first metatarsal pronation signs correlating to the metatarsus primus varus deformity of hallux valgus feet. They should be used more for preoperative and postoperative assessment. Cite this article: Bone Jt Open 2024;5(11):1037–1040


Bone & Joint Open
Vol. 5, Issue 3 | Pages 210 - 217
13 Mar 2024
Mthethwa PG Marais LC Aldous CM

Aims. The aim of this study is to determine the predictors of overall survival (OS) and predictive factors of poor prognosis of conventional high-grade osteosarcoma of the limbs in a single-centre in South Africa. Methods. We performed a retrospective cross-sectional analysis to identify the prognostic factors that predict the OS of patients with histologically confirmed high-grade conventional osteosarcoma of the limbs over ten years. We employed the Cox proportional regression model and the Kaplan-Meier method for statistical analysis. Results. This study comprised 77 patients at a three-year minimum follow-up. The predictors of poor OS were: the median age of ≤ 19 years (hazard ratio (HR) 0.96; 95% confidence interval (CI) 0.92 to 0.99; p = 0.021); median duration of symptoms ≥ five months (HR 0.91; 95% CI 0.83 to 0.99; p < 0.037); metastasis at diagnosis (i.e. Enneking stage III) (HR 3.33; 95% CI 1.81 to 6.00; p < 0.001); increased alkaline phosphatase (HR 3.28; 95% CI 1.33 to 8.11; p < 0.010); palliative treatment (HR 7.27; 95% CI 2.69 to 19.70); p < 0.001); and amputation (HR 3.71; 95% CI 1.12 to 12.25; p < 0.032). In contrast, definitive surgery (HR 0.11; 95% CI 0.03 to 0.38; p < 0.001) and curative treatment (HR 0.18; 95% CI 0.10 to 0.33; p < 0.001) were a protective factor. The Kaplan-Meier median survival time was 24 months, with OS of 57.1% at the three years. The projected five-year event-free survival was 10.3% and OS of 29.8% (HR 0.76; 95% CI 0.52 to 1.12; p = 0.128). Conclusion. In this series of high-grade conventional osteosarcoma of the appendicular skeleton from South Africa, 58.4% (n = 45) had detectable metastases at presentation; hence, an impoverished OS of five years was 29.8%. Large-scale future research is needed to validate our results. Cite this article: Bone Jt Open 2024;5(3):210–217


Bone & Joint Open
Vol. 2, Issue 10 | Pages 842 - 849
13 Oct 2021
van den Boom NAC Stollenwerck GANL Lodewijks L Bransen J Evers SMAA Poeze M

Aims. This systematic review and meta-analysis was conducted to compare open reduction and internal fixation (ORIF) with primary arthrodesis (PA) in the treatment of Lisfranc injuries, regarding patient-reported outcome measures (PROMs), and risk of secondary surgery. The aim was to conclusively determine the best available treatment based on the most complete and recent evidence available. Methods. A systematic search was conducted in PubMed, Cochrane Controlled Register of Trials (CENTRAL), EMBASE, CINAHL, PEDro, and SPORTDiscus. Additionally, ongoing trial registers and reference lists of included articles were screened. Risk of bias (RoB) and level of evidence were assessed using the Cochrane risk of bias tools and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool. The random and fixed-effect models were used for the statistical analysis. Results. A total of 20 studies were selected for this review, of which 12 were comparative studies fit for meta-analysis, including three randomized controlled trials (RCTs). This resulted in a total analyzed population of 392 patients treated with ORIF and 249 patients treated with PA. The mean differences between the two groups in American Orthopedic Foot and Ankle Society (AOFAS), VAS, and SF-36 scores were -7.41 (95% confidence interval (CI) -13.31 to -1.51), 0.77 (95% CI -0.85 to 2.39), and -1.20 (95% CI -3.86 to 1.46), respectively. Conclusion. This is the first study to find a statistically significant difference in PROMs, as measured by the AOFAS score, in favour of PA for the treatment of Lisfranc injuries. However, this difference may not be clinically relevant, and therefore drawing a definitive conclusion requires confirmation by a large prospective high-quality RCT. Such a study should also assess cost-effectiveness, as cost considerations might be decisive in decision-making. Level of Evidence: I. Cite this article: Bone Jt Open 2021;2(10):842–849


Bone & Joint Open
Vol. 2, Issue 11 | Pages 966 - 973
17 Nov 2021
Milligan DJ Hill JC Agus A Bryce L Gallagher N Beverland D

Aims

The aim of this study is to assess the impact of a pilot enhanced recovery after surgery (ERAS) programme on length of stay (LOS) and post-discharge resource usage via service evaluation and cost analysis.

Methods

Between May and December 2019, 100 patients requiring hip or knee arthroplasty were enrolled with the intention that each would have a preadmission discharge plan, a preoperative education class with nominated helper, a day of surgery admission and mobilization, a day one discharge, and access to a 24/7 dedicated helpline. Each was matched with a patient under the pre-existing pathway from the previous year.


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 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


Bone & Joint Open
Vol. 5, Issue 7 | Pages 612 - 620
19 Jul 2024
Bada ES Gardner AC Ahuja S Beard DJ Window P Foster NE

Aims

People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians’ views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial).

Methods

An online cross-sectional survey was piloted by the multidisciplinary research team, then shared with clinical professional groups in the UK who are involved in the management of adults with severe, persistent LBP. The survey had seven sections that covered the demographic details of the clinician, five hypothetical case vignettes of patients with varying presentations, a series of questions regarding the preferred management, and whether or not each clinician would be willing to recruit the example patients into future clinical trials.


Bone & Joint Open
Vol. 5, Issue 7 | Pages 581 - 591
12 Jul 2024
Wang W Xiong Z Huang D Li Y Huang Y Guo Y Andreacchio A Canavese F Chen S

Aims

To investigate the risk factors for unsuccessful radial head reduction (RHR) in children with chronic Monteggia fractures (CMFs) treated surgically.

Methods

A total of 209 children (mean age 6.84 years (SD 2.87)), who underwent surgical treatment for CMFs between March 2015 and March 2023 at six institutions, were retrospectively reviewed. Assessed risk factors included age, sex, laterality, dislocation direction and distance, preoperative proximal radial metaphysis width, time from injury to surgery, reduction method, annular ligament reconstruction, radiocapitellar joint fixation, ulnar osteotomy, site of ulnar osteotomy, preoperative and postoperative ulnar angulation, ulnar fixation method, progressive ulnar distraction, and postoperative cast immobilization. Independent-samples t-test, chi-squared test, and logistic regression analysis were used to identify the risk factors associated with unsuccessful RHR.


Bone & Joint Open
Vol. 5, Issue 11 | Pages 999 - 1003
7 Nov 2024
Tan SHS Pei Y Chan CX Pang KC Lim AKS Hui JH Ning B

Aims

Congenital pseudarthrosis of the tibia (CPT) has traditionally been a difficult condition to treat, with high complication rates, including nonunion, refractures, malalignment, and leg length discrepancy. Surgical approaches to treatment of CPT include intramedullary rodding, external fixation, combined intramedullary rodding and external fixation, vascularized fibular graft, and most recently cross-union. The current study aims to compare the outcomes and complication rates of cross-union versus other surgical approaches as an index surgery for the management of CPT. Our hypothesis was that a good index surgery for CPT achieves union and minimizes complications such as refractures and limb length discrepancy.

Methods

A multicentre study was conducted involving two institutions in Singapore and China. All patients with CPT who were surgically managed between January 2009 and December 2021 were included. The patients were divided based on their index surgery. Group 1 included patients who underwent excision of hamartoma, cross-union of the tibia and fibula, autogenic iliac bone grafting, and internal fixation for their index surgery. Group 2 included patients who underwent all other surgical procedures for their index surgery, including excision of hamartoma, intramedullary rodding, and/or external fixation, without cross-union of the tibia and fibula. Comparisons of the rates of union, refracture, limb length discrepancy, reoperations, and other complications were performed between the two groups.


Bone & Joint Open
Vol. 5, Issue 9 | Pages 799 - 805
24 Sep 2024
Fletcher WR Collins T Fox A Pillai A

Aims

The Cartiva synthetic cartilage implant (SCI) entered mainstream use in the management of first metatarsophalangeal joint (MTPJ) arthritis following the positive results of large trials in 2016. Limited information is available on the longer-term outcomes of this implant within the literature, particularly when independent from the originator. This single-centre cohort study investigates the efficacy of the Cartiva SCI at up to five years.

Methods

First MTPJ arthritis was radiologically graded according to the Hattrup and Johnson (HJ) classification. Preoperative and sequential postoperative patient-reported outcome measures (PROMs) were evaluated using the Manchester-Oxford Foot Questionnaire (MOXFQ), and the activities of daily living (ADL) sub-section of the Foot and Ankle Ability Measure (FAAM).


Bone & Joint Open
Vol. 5, Issue 11 | Pages 1020 - 1026
11 Nov 2024
Pigeolet M Sana H Askew MR Jaswal S Ortega PF Bradley SR Shah A Mita C Corlew DS Saeed A Makasa E Agarwal-Harding KJ

Aims

Lower limb fractures are common in low- and middle-income countries (LMICs) and represent a significant burden to the existing orthopaedic surgical infrastructure. In high income country (HIC) settings, internal fixation is the standard of care due to its superior outcomes. In LMICs, external fixation is often the surgical treatment of choice due to limited supplies, cost considerations, and its perceived lower complication rate. The aim of this systematic review protocol is identifying differences in rates of infection, nonunion, and malunion of extra-articular femoral and tibial shaft fractures in LMICs treated with either internal or external fixation.

Methods

This systematic review protocol describes a broad search of multiple databases to identify eligible papers. Studies must be published after 2000, include at least five patients, patients must be aged > 16 years or treated as skeletally mature, and the paper must describe a fracture of interest and at least one of our primary outcomes of interest. We did not place restrictions on language or journal. All abstracts and full texts will be screened and extracted by two independent reviewers. Risk of bias and quality of evidence will be analyzed using standardized appraisal tools. A random-effects meta-analysis followed by a subgroup analysis will be performed, given the anticipated heterogeneity among studies, if sufficient data are available.


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 479 - 488
6 Jun 2024
Paksoy A Meller S Schwotzer F Moroder P Trampuz A Imiolczyk J Perka C Hackl M Plachel F Akgün D

Aims

Current diagnostic tools are not always able to effectively identify periprosthetic joint infections (PJIs). Recent studies suggest that circulating microRNAs (miRNAs) undergo changes under pathological conditions such as infection. The aim of this study was to analyze miRNA expression in hip arthroplasty PJI patients.

Methods

This was a prospective pilot study, including 24 patients divided into three groups, with eight patients each undergoing revision of their hip arthroplasty due to aseptic reasons, and low- and high-grade PJI, respectively. The number of intraoperative samples and the incidence of positive cultures were recorded for each patient. Additionally, venous blood samples and periarticular tissue samples were collected from each patient to determine miRNA expressions between the groups. MiRNA screening was performed by small RNA-sequencing using the miRNA next generation sequencing (NGS) discovery (miND) pipeline.


Bone & Joint Open
Vol. 4, Issue 8 | Pages 584 - 593
15 Aug 2023
Sainio H Rämö L Reito A Silvasti-Lundell M Lindahl J

Aims

Several previously identified patient-, injury-, and treatment-related factors are associated with the development of nonunion in distal femur fractures. However, the predictive value of these factors is not well defined. We aimed to assess the predictive ability of previously identified risk factors in the development of nonunion leading to secondary surgery in distal femur fractures.

Methods

We conducted a retrospective cohort study of adult patients with traumatic distal femur fracture treated with lateral locking plate between 2009 and 2018. The patients who underwent secondary surgery due to fracture healing problem or plate failure were considered having nonunion. Background knowledge of risk factors of distal femur fracture nonunion based on previous literature was used to form an initial set of variables. A logistic regression model was used with previously identified patient- and injury-related variables (age, sex, BMI, diabetes, smoking, periprosthetic fracture, open fracture, trauma energy, fracture zone length, fracture comminution, medial side comminution) in the first analysis and with treatment-related variables (different surgeon-controlled factors, e.g. plate length, screw placement, and proximal fixation) in the second analysis to predict the nonunion leading to secondary surgery in distal femur fractures.


Bone & Joint Open
Vol. 5, Issue 1 | Pages 9 - 19
16 Jan 2024
Dijkstra H van de Kuit A de Groot TM Canta O Groot OQ Oosterhoff JH Doornberg JN

Aims

Machine-learning (ML) prediction models in orthopaedic trauma hold great promise in assisting clinicians in various tasks, such as personalized risk stratification. However, an overview of current applications and critical appraisal to peer-reviewed guidelines is lacking. The objectives of this study are to 1) provide an overview of current ML prediction models in orthopaedic trauma; 2) evaluate the completeness of reporting following the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) statement; and 3) assess the risk of bias following the Prediction model Risk Of Bias Assessment Tool (PROBAST) tool.

Methods

A systematic search screening 3,252 studies identified 45 ML-based prediction models in orthopaedic trauma up to January 2023. The TRIPOD statement assessed transparent reporting and the PROBAST tool the risk of bias.


Aims

Ankle fracture fixation is commonly performed by junior trainees. Simulation training using cadavers may shorten the learning curve and result in a technically superior surgical performance.

Methods

We undertook a preliminary, pragmatic, single-blinded, multicentre, randomized controlled trial of cadaveric simulation versus standard training. Primary outcome was fracture reduction on postoperative radiographs.


Bone & Joint Open
Vol. 5, Issue 4 | Pages 260 - 268
1 Apr 2024
Broekhuis D Meurs WMH Kaptein BL Karunaratne S Carey Smith RL Sommerville S Boyle R Nelissen RGHH

Aims

Custom triflange acetabular components (CTACs) play an important role in reconstructive orthopaedic surgery, particularly in revision total hip arthroplasty (rTHA) and pelvic tumour resection procedures. Accurate CTAC positioning is essential to successful surgical outcomes. While prior studies have explored CTAC positioning in rTHA, research focusing on tumour cases and implant flange positioning precision remains limited. Additionally, the impact of intraoperative navigation on positioning accuracy warrants further investigation. This study assesses CTAC positioning accuracy in tumour resection and rTHA cases, focusing on the differences between preoperative planning and postoperative implant positions.

Methods

A multicentre observational cohort study in Australia between February 2017 and March 2021 included consecutive patients undergoing acetabular reconstruction with CTACs in rTHA (Paprosky 3A/3B defects) or tumour resection (including Enneking P2 peri-acetabular area). Of 103 eligible patients (104 hips), 34 patients (35 hips) were analyzed.


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. 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 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.