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Bone & Joint Open
Vol. 4, Issue 3 | Pages 188 - 197
15 Mar 2023
Pearson NA Tutton E Gwilym SE Joeris A Grant R Keene DJ Haywood KL

Aims. To systematically review qualitative studies of patients with distal tibia or ankle fracture, and explore their experience of injury and recovery. Methods. We undertook a systematic review of qualitative studies. Five databases were searched from inception to 1 February 2022. All titles and abstracts were screened, and a subset were independently assessed. Methodological quality was appraised using the Critical Appraisal Skills Programme (CASP) checklist. The GRADE-CERQual checklist was used to assign confidence ratings. Thematic synthesis was used to analyze data with the identification of codes which were drawn together to form subthemes and then themes. Results. From 2,682 records, 15 studies were reviewed in full and four included in the review. A total of 72 patients were included across the four studies (47 female; mean age 50 years (17 to 80)). Methodological quality was high for all studies, and the GRADE-CERQual checklist provided confidence that the findings were an adequate representation of patient experience of distal tibia or ankle fracture. A central concept of ‘being the same but different’ conveyed the substantial disruption to patients’ self-identity caused by their injury. Patient experience of ‘being the same but different’ was expressed through three interrelated themes, with seven subthemes: i) being proactive where persistence, doing things differently and keeping busy prevailed; ii) living with change including symptoms, and living differently due to challenges at work and leisure; and iii) striving for normality, adapting while lacking in confidence, and feeling fearful and concerned about the future. Conclusion. Ankle injuries were disruptive, draining, and impacted on patients’ wellbeing. Substantial short- and longer-term challenges were experienced during recovery. Rehabilitation and psychosocial treatment strategies may help to ameliorate these challenges. Patients may benefit from clinicians being cognisant of patient experience when assessing, treating, and discussing expectations and outcomes with patients. Cite this article: Bone Jt Open 2023;4(3):188–197


Bone & Joint Open
Vol. 3, Issue 10 | Pages 832 - 840
24 Oct 2022
Pearson NA Tutton E Joeris A Gwilym SE Grant R Keene DJ Haywood KL

Aims

To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures.

Methods

Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_21 | Pages 22 - 22
1 Apr 2013
Zaidi R Cro S Gurusamy K Goldberg A Macgregor A
Full Access

Introduction

Surgeons, commissioners and patients are increasingly seeking more in depth details on outcomes of total ankle replacement (TAR). We set out to perform a detailed and up to date meta-analysis of the outcomes of TAR, with a focus on PROMS.

Methods

We searched MEDLINE, Cochrane, EMBASE, CINAHL and the Science Citation Index databases using the terms “total”; “ankle”; “arthroplasty” or “replacement” to April 2012. We included all languages; series with greater than 20 TAR; minimum 2 years follow-up. We excluded papers on revisions; prostheses no longer marketed; and kin studies. We worked with the Cochrane Collaboration to adopt their methodology including the creation of a risk profile assessing all forms of bias.


The Bone & Joint Journal
Vol. 101-B, Issue 10 | Pages 1256 - 1262
1 Oct 2019
Potter MJ Freeman R

Aims. Postoperative rehabilitation regimens following ankle arthrodesis vary considerably. A systematic review was conducted to determine the evidence for weightbearing recommendations following ankle arthrodesis, and to compare outcomes between different regimens. Patients and Methods. MEDLINE, Web of Science, Embase, and Scopus databases were searched for studies reporting outcomes following ankle arthrodesis, in which standardized postoperative rehabilitation regimens were employed. Eligible studies were grouped according to duration of postoperative nonweightbearing: zero to one weeks (group A), two to three weeks (group B), four to five weeks (group C), or six weeks or more (group D). Outcome data were pooled and compared between groups. Outcomes analyzed included union rates, time to union, clinical scores, and complication rates. Results. A total of 60 studies (2426 ankles) were included. Mean union rates for groups A to D were 93.2%, 95.5%, 93.0%, and 93.0%, respectively. Mean time to union was 10.4 weeks, 14.5 weeks, 12.4 weeks, and 14.4 weeks for groups A to D, respectively. Mean complication rates were 22.3%, 23.0%, 27.1%, and 28.7% for groups A to D, respectively. Reporting of outcome scores was insufficient to conduct meaningful analysis. Conclusion. Outcomes following ankle arthrodesis appear to be similar regardless of the duration of postoperative nonweightbearing, although the existing literature is insufficient to make definitive conclusions. Cite this article: Bone Joint J 2019;101-B:1256–1262


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1094 - 1098
1 Oct 2023
Jennison T Ukoumunne OC Lamb S Sharpe I Goldberg AJ

Aims

When a total ankle arthroplasty (TAA) fails, it can be converted to a fusion or a revision arthroplasty. Despite the increasing numbers of TAAs being undertaken, there is little information in the literature about the management of patients undergoing fusion following a failed TAA. The primary aim of this study was to analyze the survival of fusions following a failed TAA using a large dataset from the National Joint Registry (NJR).

Methods

A data linkage study combined NJR and NHS Digital data. Failure of a TAA was defined as a fusion, revision to a further TAA, or amputation. Life tables and Kaplan-Meier graphs were used to record survival. Cox proportional hazards regression models were fitted to compare the rates of failure.


The Bone & Joint Journal
Vol. 105-B, Issue 11 | Pages 1184 - 1188
1 Nov 2023
Jennison T Ukoumunne OC Lamb S Goldberg AJ Sharpe I

Aims

The number of revision total ankle arthroplasties (TAAs) which are undertaken is increasing. Few studies have reported the survival after this procedure. The primary aim of this study was to analyze the survival of revision ankle arthroplasties using large datasets. Secondary aims were to summarize the demographics of the patients, the indications for revision TAA, further operations, and predictors of survival.

Methods

The study combined data from the National Joint Registry and NHS Digital to report the survival of revision TAA. We have previously reported the failure rates and risk factors for failure after TAA, and the outcome of fusion after a failed TAA, using the same methodology. Survival was assessed using life tables and Kaplan Meier graphs. Cox proportional hazards regression models were fitted to compare failure rates.


Bone & Joint Open
Vol. 5, Issue 3 | Pages 227 - 235
18 Mar 2024
Su Y Wang Y Fang C Tu Y Chang C Kuan F Hsu K Shih C

Aims

The optimal management of posterior malleolar ankle fractures, a prevalent type of ankle trauma, is essential for improved prognosis. However, there remains a debate over the most effective surgical approach, particularly between screw and plate fixation methods. This study aims to investigate the differences in outcomes associated with these fixation techniques.

Methods

We conducted a comprehensive review of clinical trials comparing anteroposterior (A-P) screws, posteroanterior (P-A) screws, and plate fixation. Two investigators validated the data sourced from multiple databases (MEDLINE, EMBASE, and Web of Science). Following PRISMA guidelines, we carried out a network meta-analysis (NMA) using visual analogue scale and American Orthopaedic Foot and Ankle Score (AOFAS) as primary outcomes. Secondary outcomes included range of motion limitations, radiological outcomes, and complication rates.


The Bone & Joint Journal
Vol. 106-B, Issue 1 | Pages 46 - 52
1 Jan 2024
Hintermann B Peterhans U Susdorf R Horn Lang T Ruiz R Kvarda P

Aims

Implant failure has become more common as the number of primary total ankle arthroplasties (TAAs) performed has increased. Although revision arthroplasty has gained attention for functional preservation, the long-term results remain unclear. This study aimed to assess the long-term outcomes of revision TAA using a mobile-bearing prosthesis in a considerably large cohort; the risk factors for failure were also determined.

Methods

This single-centre retrospective cohort study included 116 patients (117 ankles) who underwent revision TAA for failed primary TAA between July 2000 and March 2010. Survival analysis and risk factor assessment were performed, and clinical performance and patient satisfaction were evaluated preoperatively and at last follow-up.


Bone & Joint Open
Vol. 4, Issue 12 | Pages 957 - 963
18 Dec 2023
van den Heuvel S Penning D Sanders F van Veen R Sosef N van Dijkman B Schepers T

Aims

The primary aim of this study was to present the mid-term follow-up of a multicentre randomized controlled trial (RCT) which compared the functional outcome following routine removal (RR) to the outcome following on-demand removal (ODR) of the syndesmotic screw (SS).

Methods

All patients included in the ‘ROutine vs on DEmand removal Of the syndesmotic screw’ (RODEO) trial received the Olerud-Molander Ankle Score (OMAS), American Orthopaedic Foot and Ankle Hindfoot Score (AOFAS), Foot and Ankle Outcome Score (FAOS), and EuroQol five-dimension questionnaire (EQ-5D). Out of the 152 patients, 109 (71.7%) completed the mid-term follow-up questionnaire and were included in this study (53 treated with RR and 56 with ODR). Median follow-up was 50 months (interquartile range 43.0 to 56.0) since the initial surgical treatment of the acute syndesmotic injury. The primary outcome of this study consisted of the OMAS scores of the two groups.


The Bone & Joint Journal
Vol. 95-B, Issue 11 | Pages 1500 - 1507
1 Nov 2013
Zaidi R Cro S Gurusamy K Sivanadarajah N Macgregor A Henricson A Goldberg A

We performed a systematic review and meta-analysis of modern total ankle replacements (TARs) to determine the survivorship, outcome, complications, radiological findings and range of movement, in patients with end-stage osteoarthritis (OA) of the ankle who undergo this procedure. We used the methodology of the Cochrane Collaboration, which uses risk of bias profiling to assess the quality of papers in favour of a domain-based approach. Continuous outcome scores were pooled across studies using the generic inverse variance method and the random-effects model was used to incorporate clinical and methodological heterogeneity. We included 58 papers (7942 TARs) with an interobserver reliability (Kappa) for selection, performance, attrition, detection and reporting bias of between 0.83 and 0.98. The overall survivorship was 89% at ten years with an annual failure rate of 1.2% (95% confidence interval (CI) 0.7 to 1.6). The mean American Orthopaedic Foot and Ankle Society score changed from 40 (95% CI 36 to 43) pre-operatively to 80 (95% CI 76 to 84) at a mean follow-up of 8.2 years (7 to 10) (p < 0.01). Radiolucencies were identified in up to 23% of TARs after a mean of 4.4 years (2.3 to 9.6). The mean total range of movement improved from 23° (95% CI 19 to 26) to 34° (95% CI 26 to 41) (p = 0.01). Our study demonstrates that TAR has a positive impact on patients’ lives, with benefits lasting ten years, as judged by improvement in pain and function, as well as improved gait and increased range of movement. However, the quality of evidence is weak and fraught with biases and high quality randomised controlled trials are required to compare TAR with other forms of treatment such as fusion. Cite this article: Bone Joint J 2013;95-B:1500–7


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 68 - 75
1 Jan 2022
Harris NJ Nicholson G Pountos I

Aims

The ideal management of acute syndesmotic injuries in elite athletes is controversial. Among several treatment methods used to stabilize the syndesmosis and facilitate healing of the ligaments, the use of suture tape (InternalBrace) has previously been described. The purpose of this study was to analyze the functional outcome, including American Orthopaedic Foot & Ankle Society (AOFAS) scores, knee-to-wall measurements, and the time to return to play in days, of unstable syndesmotic injuries treated with the use of the InternalBrace in elite athletes.

Methods

Data on a consecutive group of elite athletes who underwent isolated reconstruction of the anterior inferior tibiofibular ligament using the InternalBrace were collected prospectively. Our patient group consisted of 19 elite male athletes with a mean age of 24.5 years (17 to 52). Isolated injuries were seen in 12 patients while associated injuries were found in seven patients (fibular fracture, medial malleolus fracture, anterior talofibular ligament rupture, and posterior malleolus fracture). All patients had a minimum follow-up period of 17 months (mean 27 months (17 to 35)).


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_17 | Pages 20 - 20
1 Nov 2014
Wong-Chung J Marley W McKenna S O'Longain D
Full Access

Introduction:. Although dislocation of the peroneal tendons (PT's) in association with calcaneal fractures has been described over 25 years ago, it frequently passes unrecognised by radiologists and orthopaedic surgeons. This retrospective study aims to determine the prevalence of PT dislocation in association with calcaneal fractures at a single institution and describe systematic steps to avoid missed diagnosis at each stage of management. Methods:. CT scans of all patients with calcaneal fractures from the Picture Archiving and Communications System (PACS) from 2010 were systematically reviewed. The senior author and a Musculoskeletal Radiologist analysed the images for concomitant dislocation or subluxation of the PT's, utilizing criteria as defined by Ho et al. Further to this we included patients who sustained calcaneal fractures with associated PT dislocation prior to June 2010 and were referred either for primary open reduction or later with post-traumatic osteoarthrosis of the subtalar joint. Results:. Over three years and nine months beginning in June 2010, 71 calcaneal fractures were identified on PACS. 15 of those had associated subluxation or dislocation of the peroneal tendons either on CT scan or at surgery (21%). 10 of our 71 patients exhibited a fleck sign on plain anteroposterior ankle x-ray (14.1%) suggesting potential avulsion of the superior peroneal retinaculum. The combined cohort comprised 28 patients, 23 men and 5 women, aged 21 to 82 years (average, 46.3 years). 22 (79%) of PT dislocations were not recognised at the original injury. In six patients undergoing operative fixation, five (83.3%) had dislocated PT's noted on CT scan. In one case (16.7%) the peroneal tendons were clinically dislocated. Conclusion:. The PT dislocation rate in this paper is comparable with the literature. Patients should undergo careful clinical examination, radiological assessment with x-ray and CT followed by probing at surgery to ensure the diagnosis is not missed


The Bone & Joint Journal
Vol. 103-B, Issue 11 | Pages 1709 - 1716
1 Nov 2021
Sanders FRK Birnie MF Dingemans SA van den Bekerom MPJ Parkkinen M van Veen RN Goslings JC Schepers T

Aims

The aim of this study was to investigate whether on-demand removal (ODR) is noninferior to routine removal (RR) of syndesmotic screws regarding functional outcome.

Methods

Adult patients (aged above 17 years) with traumatic syndesmotic injury, surgically treated within 14 days of trauma using one or two syndesmotic screws, were eligible (n = 490) for inclusion in this randomized controlled noninferiority trial. A total of 197 patients were randomized for either ODR (retaining the syndesmotic screw unless there were complaints warranting removal) or RR (screw removed at eight to 12 weeks after syndesmotic fixation), of whom 152 completed the study. The primary outcome was functional outcome at 12 months after screw placement, measured by the Olerud-Molander Ankle Score (OMAS).


The Bone & Joint Journal
Vol. 95-B, Issue 4 | Pages 498 - 503
1 Apr 2013
Yammine K Harvey A

We report a systematic review and meta-analysis of published randomised and quasi-randomised trials evaluating the efficacy of pre-operative skin antisepsis and cleansing techniques in reducing foot and ankle skin flora. The post-preparation culture number (Post-PCN) was the primary outcome. The data were evaluated using a modified version of the Cochrane Collaboration’s tool. We identified eight trials (560 participants, 716 feet) that met the inclusion criteria. There was a significant difference in the proportions of Post-PCN between hallux nailfold (HNF) and toe web spaces (TWS) sites: 0.47 vs 0.22, respectively (95% confidence interval (CI) 0.182937 to 0.304097; p < 0.0001). Meta-analyses showed that alcoholic chlorhexidine had better efficacy than alcoholic povidone-iodine (PI) at HNF sites (risk difference 0.19 (95% CI 0.08 to 0.30); p = 0.0005); a two-step intervention using PI scrub and paint (S& P) followed by alcohol showed significantly better efficacy over PI (S& P) alone at TWS sites (risk difference 0.13 (95% CI 0.02 to 0.24); p = 0.0169); and a two-step intervention using chlorhexidine scrub followed by alcohol showed significantly better efficacy over PI (S& P) alone at the combined (HNF with TWS) sites (risk difference 0.27 (95% CI 0.13 to 0.40); p < 0.0001). No significant difference was found between cleansing techniques. Cite this article: Bone Joint J 2013;95-B:498–503


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIII | Pages 19 - 19
1 Sep 2012
Hutchison A Topliss C Williams P Pallister I Beard D
Full Access

Introduction. Chronic mid body Achilles tendinopathy is a common problem. There is no consensus on treatment. The aim of this review was to assess the effectiveness of physiotherapy interventions (non surgical and non pharmacological) for this condition. Methods. A systematic review of the literature was conducted. A search of published and grey literature databases was undertaken (1999- December 2010). Two reviewers independently assessed the studies for eligibility using a strict inclusion and exclusion criteria. All eligible articles were assessed critically using the Pedro score. Data on cohort characteristics, diagnostic criteria, treatment intervention, outcome measures and results was extracted. A narrative research synthesis method was adopted. Results. 209 studies were identified. Nine publications met the review inclusion criteria. Methodological quality was adequate for all nine studies; however, blinding was a limitation for most. Interventions investigated were; Exercises (n = 2), Low level laser therapy (n = 1), Low energy shockwave treatment (SWT) (n = 3), Air cast brace (n = 2) and Insoles (n = 1). Some evidence exists for eccentric exercises in combination with SWT or Laser. However, contrary to other reviews, eccentric exercises were not found to be superior to other physiotherapy treatments. Conclusions. There is insufficient evidence to determine which method of physiotherapy is most appropriate for a chronic Achilles tendinopathy. Further well designed randomised controlled trials assessing physiotherapy interventions with specific diagnostic criteria and appropriate outcome tools are required to determine the efficacy of physiotherapy for the condition


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIII | Pages 6 - 6
1 Sep 2012
Monda M Cullen N Singh D Goldberg A
Full Access

Introduction. The Z or “scarf” osteotomy was first described by Meyer in 1926 and then by Burutaran in 1976. It was later popularised by Weil in the USA and Barouk in Europe in the 1990's and is now an accepted technique that forms part of a surgeons' armamentarium. The theory of Diffusion of Innovations was described by Rogers in 1962 to explain how novel ideas are accepted into practice across different industries, including medicine. It has never previously been used to study the adoption of ideas in foot and ankle surgery. Methods. This paper uses publication volume as a surrogate marker for adoption, as described previously by the authors. Briefly, a systematic review of the literature was carried out. MESH headings included ‘Hallux Valgus’, and ‘osteotomy’ or ‘SCARF’ or ‘Z osteotomy’ or ‘bunionectomy’. 2818 publications were identified and the abstracts were reviewed excluding 2699 publications for non-relevance. The data was analysed by year of publication, country of origin, as well as for level of evidence. Results. There were 120 publications relating to SCARF osteotomy, which when plotted on a graph produced an s shaped curve. 58% of publications came from Europe and 38% from the USA. There was only a single level 1 paper published in 2008. Discussion. This study confirms that publication volume is a surrogate marker for adoption and that SCARF osteotomy became adopted by the late 2000's as indicated by the plateau on an s-shaped curve. Post market surveillance has led to a further rise in recent publications indicating that certain issues still need resolving before the laggards adopt this technique. Despite SCARF having been around for more than 80 years, very little high level evidence has been published of its effectiveness. Recommendations are made as to how future innovations should be introduced in foot and ankle surgery


Bone & Joint Open
Vol. 2, Issue 7 | Pages 503 - 508
8 Jul 2021
Callaghan CJ McKinley JC

Aims

Arthroplasty has become increasingly popular to treat end-stage ankle arthritis. Iatrogenic posterior neurovascular and tendinous injury have been described from saw cuts. However, it is hypothesized that posterior ankle structures could be damaged by inserting tibial guide pins too deeply and be a potential cause of residual hindfoot pain.

Methods

The preparation steps for ankle arthroplasty were performed using the Infinity total ankle system in five right-sided cadaveric ankles. All tibial guide pins were intentionally inserted past the posterior tibial cortex for assessment. All posterior ankles were subsequently dissected, with the primary endpoint being the presence of direct contact between the structure and pin.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXII | Pages 68 - 68
1 May 2012
Loveday D Clifton R Robinson A
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Introduction. Osteochondral defects of the talus are usually a consequence of trauma. They can cause chronic pain and serious disability. Various interventions, non-surgical and surgical, have been used for treating these defects. The objective of this Cochrane systematic review of randomised control trials is to determine the benefits and harms of the interventions used for treating osteochondral defects of the talus in adults. Methods. We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, MEDLINE In-Process, EMBASE, Current Controlled Trials, the WHO International Clinical Trials Registry Platform and reference lists of articles. Date of last search: December 2009. Eligible for inclusion were any randomised or quasi-randomised controlled clinical trials evaluating interventions for treating osteochondral defects of the talus in adults. Our primary outcomes included pain, ankle function, treatment failure (unresolved symptoms or reoperation) and health-related quality of life. Preference was given to validated, patient-reported outcome measures. Two review authors independently evaluated trials for inclusion and, for the included trial, independently assessed the risk of bias and extracted data. Results. One small trial with 15 participants and six months follow-up was included. This trial was published only as a conference abstract, which provided inadequate information to judge the trial's methods and no numerical results. The trial reported that a series of three intra-articular hyaluronan injections started three weeks after arthroscopic microfracture did not improve pain but may have improved one aspect of mobility. There were no available data to check this claim. An important finding of this review is that one allegedly randomised trial, which compared three surgical interventions, was not randomised or quasi-randomised. Upon further clarification from contacting the lead trial author, it became clear that this was a comparative study only. The only other randomised trial found was an ongoing trial with a published protocol. This is studying pulsed electromagnetic fields after arthroscopic treatment for osteochondral defects of the talus. Conclusions. There is insufficient evidence from randomised trials to determine which interventions are best for osteochondral defects of the talus in adults. High quality randomised trials are required to guide non-surgical and surgical treatment decisions for these injuries


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 696 - 703
1 Apr 2021
Clough TM Ring J

Aims

We report the medium-term outcomes of a consecutive series of 118 Zenith total ankle arthroplasties (TAAs) from a single, non-designer centre.

Methods

Between December 2010 and May 2016, 118 consecutive Zenith prostheses were implanted in 114 patients. Demographic, clinical, and patient-reported outcome measures (PROMs) data were collected. The endpoint of the study was failure of the implant requiring revision of one or all of the components. Kaplan-Meier survival curves were generated with 95% confidence intervals (CIs) and the rate of failure calculated for each year.


Bone & Joint Open
Vol. 2, Issue 3 | Pages 150 - 163
1 Mar 2021
Flett L Adamson J Barron E Brealey S Corbacho B Costa ML Gedney G Giotakis N Hewitt C Hugill-Jones J Hukins D Keding A McDaid C Mitchell A Northgraves M O'Carroll G Parker A Scantlebury A Stobbart L Torgerson D Turner E Welch C Sharma H

Aims

A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients’ quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures.

Methods

A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods.