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Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIII | Pages 26 - 26
1 Sep 2012
Higgins D Deakin S Thorisdottir V
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Patient reported outcomes and satisfaction as a measure of service quality is becoming an increasingly important tool in local service assessment as well as a quality indicator within commissioning frameworks. We analyse the introduction of SCP led MDT facilitated patient group meetings addressing the education and preparation of patients listed for ankle and hindfoot surgery at WSH HYPOTHESIS- To identify the outcome benefits to patients from this type of quality initiative. This has been previously demonstrated in other specialities in the trust such as hip and knee replacement resulting in mandatory attendance as part of the care pathway. Feedback was gathered via a patient questionnaire from 60 patients invited to meetings over an 18 month period. Two groups of patients who have undergone hindfoot/ankle surgery at WSH were compared. Group 1 attended a 1 hour MDT meeting preoperatively designed to educate the patient on all aspects of their surgery from pre assessment through to post operative management. Group 2 did not attend any such meeting whether invited or not. Results. Group 1 found the meetings beneficial in preparing them for surgery and improved their knowledge of disease, treatment options and recovery. Group 2 felt less prepared with less knowledge of post op limitations, and available support. No significant difference in length of stay was observed. Recommendations. Additional to their consultant examination, patients undergoing major foot surgery benefit from receiving additional information provided by a mixed group of professionals involved in their care. Physiotherapists and occupational therapists as well as volunteer post operative patients at these meetings provided valuable advice and instruction in preparing for and recovering from this type of surgery


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

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


The Bone & Joint Journal
Vol. 105-B, Issue 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. Results. A total of 131 patients underwent fusion as a salvage procedure following TAA. Their mean age was 65.7 years (SD 10.6) and 73 (55.7%) were male. The mean follow-up was 47.5 months (SD 27.2). The mean time between TAA and fusion was 5.3 years (SD 2.7). Overall, 32 (24.4%) underwent reoperations other than revision and 29 (22.1%) failed. Of these 24 (18.3%) underwent revision of the fusion and five (3.8%) had a below-knee amputation. No patients underwent conversion to a further TAA. Failure usually occurred in the first three postoperative years with one-year survival of fusion being 96.0% (95% confidence interval (CI) 90.7 to 98.3) and three-year survival in 69 patients being 77.5% (95% CI 68.3 to 84.4). Conclusion. Salvage fusion after a failed TAA shows moderate rates of failure and reoperations. Nearly 25% of patients required revision within three years. This study is an extension of studies using the same methodology reporting the failure rates and risk factors for failure, which have recently been published, and also one reporting the outcome of revision TAA for a failed primary TAA, using the same methodology, which will shortly be published. Cite this article: Bone Joint J 2023;105-B(10):1094–1098


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). Results. Patients were followed up for a mean of 66 months (SD 7.1). Of an initial 66 cases, 16 did not return PROM questionnaires. A total of six failures were noted, with survival of 82%. Overall, significant improvement in both objective scores (MOXFQ and FAAM ADL) was maintained versus preoperatively: 18.2 versus 58.0 (p > 0.001) and 86.2 versus 41.1 (p > 0.001), respectively. The improvement was noted to be less pronounced in males. Subjective scores had deteriorated since early follow-up, with an interval decrease in patient satisfaction from 89% to 68%. Furthermore, a subset of cases demonstrated clinically important interval deterioration in objective scores. However, no specific patient factors were found to be associated with outcomes following analysis. Conclusion. This study represents the longest-term independent follow-up in the literature. It shows reassuring mid-term efficacy of the Cartiva SCI with better-than-expected survival. However, deterioration in scores for a subset of patients and lower satisfaction may predict ongoing failure in this group of patients. Additionally, males were noted to have a lower degree of improvement in scores than females. As such, ongoing observation of the SCI to assess durability and survivability, and identify predictive factors, is key to improving patient selection. Cite this article: Bone Jt Open 2024;5(9):799–805


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_7 | Pages 23 - 23
8 May 2024
Jayatilaka M Fisher A Fisher L Molloy A Mason L
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Introduction. The treatment of posterior malleolar fractures is developing. Mason and Molloy (Foot Ankle Int. 2017 Nov;38(11):1229-1235) identified only 49% of posterior malleolar rotational pilon type fractures had syndesmotic instabilities. This was against general thinking that fixation of such a fragment would stabilize the syndesmosis. Methods. We examined 10 cadaveric lower limbs that had been preserved for dissection at the Human Anatomy and Resource Centre at Liverpool University in a solution of formaldehyde. The lower limbs were carefully dissected to identify the ligamentous structures on the posterior aspect of the ankle. To compare the size to the rotational pilon posterior malleolar fracture (Mason and Molloy 2A and B) we gathered information from our posterior malleolar fracture database. 3D CT imaging was analysed using our department PACS system. Results. The PITFL insertion on the posterior aspect of the tibia is very large. The average size of insertion was 54.9×47.1mm across the posterior aspect of the tibia. Medially the PITFL blends into the sheath of tibialis posterior and laterally into the peroneal tendon sheath. 78 posterior lateral and 35 posterior medial fragments were measured. On average, the lateral to medial size of the posteromalleolar fragment was 24.5mm in the posterolateral fragment, and 43mm if there is a posteromedial fragment present also. The average distal to proximal size of the posterolateral fragment was 24.5mm and 18.5mm for the posteromedial fragment. Conclusion. The PITFL insertion on the tibia is broad. In comparison to the average size of the posterior malleolar fragments, the PITFL insertion is significantly bigger. Therefore, for a posterior malleolar fracture to cause posterior syndesmotic instability, a ligamentous injury will also have to occur. This explains the finding by Mason and Molloy that only 49% of type 2 injuries had a syndesmotic injury on testing


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_13 | Pages 18 - 18
17 Jun 2024
Andres L Donners R Harder D Krähenbühl N
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Background. Weightbearing computed tomography scans allow for better understanding of foot alignment in patients with Progressive Collapsing Foot Deformity. However, soft tissue integrity cannot be assessed via WBCT. As performing both WBCT and magnetic resonance imaging is not cost effective, we aimed to assess whether there is an association between specific WBCT and MRI findings. Methods. A cohort of 24 patients of various stages of PCFD (mean age 51±18 years) underwent WBCT scans and MRI. In addition to signs of sinus tarsi impingement, four three-dimensional measurements (talo-calcaneal overlap, talo-navicular coverage, Meary's angle axial/lateral) were obtained using a post processing software (DISIOR 2.1, Finland) on the WBCT datasets. Sinus tarsi obliteration, spring ligament complex and tibiospring ligament integrity, as well as tibialis posterior tendon degeneration were evaluated with MRI. Statistical analysis was performed for significant (P<0.05) correlation between findings. Results. None of the assessed 3D measurements correlated with spring ligament complex or tibiospring ligament tears. Age, body mass index, and TCO were associated with tibialis posterior tendon tears. 75% of patients with sinus tarsi impingement on WBCT also showed signs of sinus tarsi obliteration on MRI. Of the assessed parameters, only age and BMI were associated with sinus tarsi obliteration diagnosed on MRI, while the assessed WBCT based 3D measurements were, with the exception of MA axial, associated with sinus tarsi impingement. Conclusion. While WBCT reflects foot alignment and indicates signs of osseous impingement in PCFD patients, the association between WBCT based 3D measurements and ligament or tendon tears in MRI is limited. Partial or complete tears of the tibialis posterior tendon were only detectable in comparably older and overweight PCFD patients with an increased TCO. WBCT does not replace MRI in diagnostic value. Both imaging options add important information and may impact decision-making in the treatment of PCFD patients


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_12 | Pages 16 - 16
10 Jun 2024
Azam M Colasanti C Butler J Weiss M Brodeur P Kennedy J
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Introduction. The purpose of this study was to examine trends in patient characteristics and clinical outcomes that occur with age as a statistical variable when performing autologous osteochondral transplantation (AOT) for the treatment of osteochondral lesions of the talus (OLT). Methods. A retrospective cohort study for AOT procedures on 78 patients from 2006 to 2019. was conducted Clinical outcomes were evaluated via FAOS scores. A multivariable linear regression was used to assess the independent factors predictive of the first post-operative FAOS after AOT. The independent variables included pre-operative FAOS, age, defect size, shoulder lesion, cystic lesion, prior traumatic injury, and history of microfracture surgery. A p-value <.05 was considered significant and 95% confidence limits (95% CL) for regression coefficient estimates (est.) were calculated. Results. 78 patients were included with a mean age of 35.5 ± 13.6years at a mean follow-up was 54.4 ± 18.9 months. The mean pre-operative FAOS was 54.3 ± 19.4 and the mean post-operative FAOS was 83.4 ± 13.6. The mean defect size was 109.3±62.4 mm2. The multivariable linear regression showed that the pre-operative FAOS was associated with a higher post-operative FAOS (est., 95% CL: 0.16, 0.012 – 0.307; p=0.034). Defect size (est., 95% CL: −0.05, −0.097 – −0.003; p=0.0358), having a shoulder lesion (est., 95% CL: −9.068, −15.448 – −2.688; p=0.006), or having a prior microfracture surgery (est., 95% CL: −7.07, −13.118 – −1.021; p=0.0226) were associated with a lower post-operative FAOS. Conclusion. Patient age was not an independent risk factor for inferior clinical outcomes after AOT for OLT. Additionally, cystic lesions, or lesions with a traumatic aetiology were not significantly associated with post-operative FAOS. Having a shoulder lesion had the largest marginal effect on post-operative FAOS. These findings provide important information for providers when counseling and selecting patients for AOT procedure for treatment of OLT


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 895 - 904
1 Aug 2023
Smith TO Dainty J Loveday DT Toms A Goldberg AJ Watts L Pennington MW Dawson J van der Meulen J MacGregor AJ

Aims

The aim of this study was to capture 12-month outcomes from a representative multicentre cohort of patients undergoing total ankle arthroplasty (TAA), describe the pattern of patient-reported outcome measures (PROMs) at 12 months, and identify predictors of these outcome measures.

Methods

Patients listed for a primary TAA at 19 NHS hospitals between February 2016 and October 2017 were eligible. PROMs data were collected preoperatively and at six and 12 months including: Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ (foot and ankle)) and the EuroQol five-dimension five-level questionnaire (EQ-5D-5L). Radiological pre- and postoperative data included Kellgren-Lawrence score and implant position measurement. This was supplemented by data from the National Joint Registry through record linkage to determine: American Society of Anesthesiologists (ASA) grade at index procedure; indication for surgery, index ankle previous fracture; tibial hind foot alignment; additional surgery at the time of TAA; and implant type. Multivariate regression models assessed outcomes, and the relationship between MOXFQ and EQ-5D-5L outcomes, with patient characteristics.


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1099 - 1107
1 Oct 2023
Henry JK Shaffrey I Wishman M Palma Munita J Zhu J Cody E Ellis S Deland J Demetracopoulos C

Aims

The Vantage Total Ankle System is a fourth-generation low-profile fixed-bearing implant that has been available since 2016. We aimed to describe our early experience with this implant.

Methods

This is a single-centre retrospective review of patients who underwent primary total ankle arthroplasty (TAA) with a Vantage implant between November 2017 and February 2020, with a minimum of two years’ follow-up. Four surgeons contributed patients. The primary outcome was reoperation and revision rate of the Vantage implant at two years. Secondary outcomes included radiological alignment, peri-implant complications, and pre- and postoperative patient-reported outcomes.


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.


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 11 | Pages 1249 - 1256
1 Nov 2024
Mangwani J Houchen-Wolloff L Malhotra K Booth S Smith A Teece L Mason LW

Aims

Venous thromboembolism (VTE) is a potential complication of foot and ankle surgery. There is a lack of agreement on contributing risk factors and chemical prophylaxis requirements. The primary outcome of this study was to analyze the 90-day incidence of symptomatic VTE and VTE-related mortality in patients undergoing foot and ankle surgery and Achilles tendon (TA) rupture. Secondary aims were to assess the variation in the provision of chemical prophylaxis and risk factors for VTE.

Methods

This was a multicentre, prospective national collaborative audit with data collection over nine months for all patients undergoing foot and ankle surgery in an operating theatre or TA rupture treatment, within participating UK hospitals. The association between VTE and thromboprophylaxis was assessed with a univariable logistic regression model. A multivariable logistic regression model was used to identify key predictors for the risk of VTE.


Bone & Joint Research
Vol. 13, Issue 7 | Pages 315 - 320
1 Jul 2024
Choi YH Kwon TH Choi JH Han HS Lee KM

Aims

Achilles tendon re-rupture (ATRR) poses a significant risk of postoperative complication, even after a successful initial surgical repair. This study aimed to identify risk factors associated with Achilles tendon re-rupture following operative fixation.

Methods

This retrospective cohort study analyzed a total of 43,287 patients from national health claims data spanning 2008 to 2018, focusing on patients who underwent surgical treatment for primary Achilles tendon rupture. Short-term ATRR was defined as cases that required revision surgery occurring between six weeks and one year after the initial surgical repair, while omitting cases with simultaneous infection or skin necrosis. Variables such as age, sex, the presence of Achilles tendinopathy, and comorbidities were systematically collected for the analysis. We employed multivariate stepwise logistic regression to identify potential risk factors associated with short-term ATRR.


The Bone & Joint Journal
Vol. 106-B, Issue 3 | Pages 256 - 261
1 Mar 2024
Goodall R Borsky K Harrison CJ Welck M Malhotra K Rodrigues JN

Aims

The Manchester-Oxford Foot Questionnaire (MOxFQ) is an anatomically specific patient-reported outcome measure (PROM) currently used to assess a wide variety of foot and ankle pathology. It consists of 16 items across three subscales measuring distinct but related traits: walking/standing ability, pain, and social interaction. It is the most used foot and ankle PROM in the UK. Initial MOxFQ validation involved analysis of 100 individuals undergoing hallux valgus surgery. This project aimed to establish whether an individual’s response to the MOxFQ varies with anatomical region of disease (measurement invariance), and to explore structural validity of the factor structure (subscale items) of the MOxFQ.

Methods

This was a single-centre, prospective cohort study involving 6,637 patients (mean age 52 years (SD 17.79)) presenting with a wide range of foot and ankle pathologies between January 2013 and December 2021. To assess whether the MOxFQ responses vary by anatomical region of foot and ankle disease, we performed multigroup confirmatory factor analysis. To assess the structural validity of the subscale items, exploratory and confirmatory factor analyses were performed.


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 942 - 948
1 Sep 2024
Kingery MT Kadiyala ML Walls R Ganta A Konda SR Egol KA

Aims

This study evaluated the effect of treating clinician speciality on management of zone 2 fifth metatarsal fractures.

Methods

This was a retrospective cohort study of patients with acute zone 2 fifth metatarsal fractures who presented to a single large, urban, academic medical centre between December 2012 and April 2022. Zone 2 was the region of the fifth metatarsal base bordered by the fourth and fifth metatarsal articulation on the oblique radiograph. The proportion of patients allowed to bear weight as tolerated immediately after injury was compared between patients treated by orthopaedic surgeons and podiatrists. The effects of unrestricted weightbearing and foot and/or ankle immobilization on clinical healing were assessed. A total of 487 patients with zone 2 fractures were included (mean age 53.5 years (SD 16.9), mean BMI 27.2 kg/m2 (SD 6.0)) with a mean follow-up duration of 2.57 years (SD 2.64).


The Bone & Joint Journal
Vol. 105-B, Issue 3 | Pages 301 - 306
1 Mar 2023
Jennison T Ukoumunne O Lamb S Sharpe I Goldberg AJ

Aims

Despite the increasing numbers of ankle arthroplasties, there are limited studies on their survival and comparisons between different implants. The primary aim of this study was to determine the failure rates of primary ankle arthroplasties commonly used in the UK.

Methods

A data linkage study combined National Joint Registry (NJR) data and NHS Digital data. The primary outcome of failure was defined as the removal or exchange of any components of the implanted device. Life tables and Kaplan-Meier survival charts were used to illustrate survivorship. Cox proportional hazards regression models were fitted to compare failure rates between 1 April 2010 and 31 December 2018.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1443 - 1450
1 Dec 2024
Down B Ferguson J Loizou C McNally M Ramsden A Stubbs D Kendal A

Aims

Calcaneal osteomyelitis remains a difficult condition to treat with high rates of recurrence and below-knee amputation, particularly in the presence of severe soft-tissue destruction. This study assesses the outcomes of single-stage orthoplastic surgical treatment of calcaneal osteomyelitis with large soft-tissue defects.

Methods

A retrospective review was performed of all patients who underwent combined single-stage orthoplastic treatment of calcaneal osteomyelitis (01/2008 to 12/2022). Primary outcome measures were osteomyelitis recurrence and below-knee amputation (BKA). Secondary outcome measures included flap failure, operating time, complications, and length of stay.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 382 - 388
15 Mar 2023
Haque A Parsons H Parsons N Costa ML Redmond AC Mason J Nwankwo H Kearney RS

Aims

The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture.

Methods

This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant’s ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years.


Bone & Joint Open
Vol. 3, Issue 10 | Pages 841 - 849
27 Oct 2022
Knight R Keene DJ Dutton SJ Handley R Willett K

Aims

The rationale for exacting restoration of skeletal anatomy after unstable ankle fracture is to improve outcomes by reducing complications from malunion; however, current definitions of malunion lack confirmatory clinical evidence.

Methods

Radiological (absolute radiological measurements aided by computer software) and clinical (clinical interpretation of radiographs) definitions of malunion were compared within the Ankle Injury Management (AIM) trial cohort, including people aged ≥ 60 years with an unstable ankle fracture. Linear regressions were used to explore the relationship between radiological malunion (RM) at six months and changes in function at three years. Function was assessed with the Olerud-Molander Ankle Score (OMAS), with a minimal clinically important difference set as six points, as per the AIM trial. Piecewise linear models were used to investigate new radiological thresholds which better explain symptom impact on ankle function.


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.