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Bone & Joint Open
Vol. 1, Issue 4 | Pages 64 - 73
20 Apr 2020
Davaris MT Dowsey MM Bunzli S Choong PF

Aims

Total joint replacement (TJR) is a high-cost, high-volume procedure that impacts patients’ quality of life. Informed decisions are important for patients facing TJR. The quality of information provided by websites regarding TJR is highly variable. We aimed to measure the quality of TJR information online.

Methods

We identified 10,800 websites using 18 TJR-related keywords (conditions and procedures) across the Australian, French, German and Spanish Google search engines. We used the Health on the Net (HON) toolbar to evaluate the first 150 websites downloaded for every keyword in each language. The quality of information on websites was inspected, accounting for differences by language and tertiles. We also undertook an analysis of English websites to explore types of website providers.


Bone & Joint Open
Vol. 5, Issue 2 | Pages 139 - 146
15 Feb 2024
Wright BM Bodnar MS Moore AD Maseda MC Kucharik MP Diaz CC Schmidt CM Mir HR

Aims. While internet search engines have been the primary information source for patients’ questions, artificial intelligence large language models like ChatGPT are trending towards becoming the new primary source. The purpose of this study was to determine if ChatGPT can answer patient questions about total hip (THA) and knee arthroplasty (TKA) with consistent accuracy, comprehensiveness, and easy readability. Methods. We posed the 20 most Google-searched questions about THA and TKA, plus ten additional postoperative questions, to ChatGPT. Each question was asked twice to evaluate for consistency in quality. Following each response, we responded with, “Please explain so it is easier to understand,” to evaluate ChatGPT’s ability to reduce response reading grade level, measured as Flesch-Kincaid Grade Level (FKGL). Five resident physicians rated the 120 responses on 1 to 5 accuracy and comprehensiveness scales. Additionally, they answered a “yes” or “no” question regarding acceptability. Mean scores were calculated for each question, and responses were deemed acceptable if ≥ four raters answered “yes.”. Results. The mean accuracy and comprehensiveness scores were 4.26 (95% confidence interval (CI) 4.19 to 4.33) and 3.79 (95% CI 3.69 to 3.89), respectively. Out of all the responses, 59.2% (71/120; 95% CI 50.0% to 67.7%) were acceptable. ChatGPT was consistent when asked the same question twice, giving no significant difference in accuracy (t = 0.821; p = 0.415), comprehensiveness (t = 1.387; p = 0.171), acceptability (χ. 2. = 1.832; p = 0.176), and FKGL (t = 0.264; p = 0.793). There was a significantly lower FKGL (t = 2.204; p = 0.029) for easier responses (11.14; 95% CI 10.57 to 11.71) than original responses (12.15; 95% CI 11.45 to 12.85). Conclusion. ChatGPT answered THA and TKA patient questions with accuracy comparable to previous reports of websites, with adequate comprehensiveness, but with limited acceptability as the sole information source. ChatGPT has potential for answering patient questions about THA and TKA, but needs improvement. Cite this article: Bone Jt Open 2024;5(2):139–146


Bone & Joint Open
Vol. 2, Issue 9 | Pages 745 - 751
7 Sep 2021
Yakkanti RR Sedani AB Baker LC Owens PW Dodds SD Aiyer AA

Aims. This study assesses patient barriers to successful telemedicine care in orthopaedic practices in a large academic practice in the COVID-19 era. Methods. In all, 381 patients scheduled for telemedicine visits with three orthopaedic surgeons in a large academic practice from 1 April 2020 to 12 June 2020 were asked to participate in a telephone survey using a standardized Institutional Review Board-approved script. An unsuccessful telemedicine visit was defined as patient-reported difficulty of use or reported dissatisfaction with teleconferencing. Patient barriers were defined as explicitly reported barriers of unsatisfactory visit using a process-based satisfaction metric. Statistical analyses were conducted using analysis of variances (ANOVAs), ranked ANOVAs, post-hoc pairwise testing, and chi-squared independent analysis with 95% confidence interval. Results. The survey response rate was 39.9% (n = 152). The mean age of patients was 51.1 years (17 to 85), and 55 patients (38%) were male. Of 146 respondents with completion of survey, 27 (18.5%) reported a barrier to completing their telemedicine visit. The majority of patients were satisfied with using telemedicine for their orthopaedic appointment (88.8%), and found the experience to be easy (86.6%). Patient-reported barriers included lack of proper equipment/internet connection (n = 13; 8.6%), scheduling difficulty (n = 2; 1.3%), difficulty following directions (n = 10; 6.6%), and patient-reported discomfort (n = 2; 1.3%). Barriers based on patient characteristics were age > 61 years, non-English primary language, inexperience with video conferencing, and unwillingness to try telemedicine prior to COVID-19. Conclusion. The barriers identified in this study could be used to screen patients who would potentially have an unsuccessful telemedicine visit, allowing practices to provide assistance to patients to reduce the risk of an unsuccessful visit. Cite this article: Bone Jt Open 2021;2(9):745–751


Bone & Joint Open
Vol. 1, Issue 5 | Pages 167 - 174
31 May 2020
Marson BA Craxford S Deshmukh SR Grindlay D Manning J Ollivere BJ

Aims. To analyze outcomes reported in trials of childhood fractures. Methods. OVID MEDLINE, Embase, and Cochrane CENTRAL databases were searched on the eighth August 2019. A manual search of trial registries, bibliographic review and internet search was used to identify additional studies. 11,476 studies were screened following PRISMA guidelines. 100 trials were included in the analysis. Data extraction was completed by two researchers for each trial. Study quality was not evaluated. Outcomes reported by trials were mapped onto domains in the World Health Organization (WHO) International Classification of Function framework. Results. In all, 525 outcomes were identified representing 52 WHO domains. Four domains were reported in more than 50% of trials: structure of upper/lower limb, sensation of pain, mobility of joint function, and health services, systems and policies. The Activities Scale for Kids performance (ASK-p) score was the most common outcome score reported in 6/72 upper limb and 4/28 lower limb trials. Conclusion. There is a diverse range of outcomes reported in trials of childhood fractures covering all areas in the International Classification of Functioning, Disability and Health (ICF) framework. There were three common upper limb and three common lower limb outcomes. In the absence of a core outcome set, we recommend that upper limb trials report pain, range of movement and radiograph appearance of the arm and lower limb trials report pain, radiograph appearance of the leg and healthcare costs to improve consistency of reporting in future trials. Cite this article: Bone Joint Open 2020;1-5:167–174


Bone & Joint Open
Vol. 4, Issue 7 | Pages 496 - 506
5 Jul 2023
Theunissen WWES Van der Steen MC Van Veen MR Van Douveren FQMP Witlox MA Tolk JJ

Aims

The aim of this study was to identify the information topics that should be addressed according to the parents of children with developmental dysplasia of the hip (DDH) in the diagnostic and treatment phase during the first year of life. Second, we explored parental recommendations to further optimize the information provision in DDH care.

Methods

A qualitative study with semi-structured interviews was conducted between September and December 2020. A purposive sample of parents of children aged younger than one year, who were treated for DDH with a Pavlik harness, were interviewed until data saturation was achieved. A total of 20 interviews with 22 parents were conducted. Interviews were audio recorded, transcribed verbatim, independently reviewed, and coded into categories and themes.


Bone & Joint Open
Vol. 5, Issue 7 | Pages 543 - 549
3 Jul 2024
Davies AR Sabharwal S Reilly P Sankey RA Griffiths D Archer S

Aims

Shoulder arthroplasty is effective in the management of end-stage glenohumeral joint arthritis. However, it is major surgery and patients must balance multiple factors when considering the procedure. An understanding of patients’ decision-making processes may facilitate greater support of those considering shoulder arthroplasty and inform the outcomes of future research.

Methods

Participants were recruited from waiting lists of three consultant upper limb surgeons across two NHS hospitals. Semi-structured interviews were conducted with 12 participants who were awaiting elective shoulder arthroplasty. Transcribed interviews were analyzed using a grounded theory approach. Systematic coding was performed; initial codes were categorized and further developed into summary narratives through a process of discussion and refinement. Data collection and analyses continued until thematic saturation was reached.


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

Aims

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

Methods

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


Bone & Joint Open
Vol. 3, Issue 11 | Pages 877 - 884
14 Nov 2022
Archer H Reine S Alshaikhsalama A Wells J Kohli A Vazquez L Hummer A DiFranco MD Ljuhar R Xi Y Chhabra A

Aims

Hip dysplasia (HD) leads to premature osteoarthritis. Timely detection and correction of HD has been shown to improve pain, functional status, and hip longevity. Several time-consuming radiological measurements are currently used to confirm HD. An artificial intelligence (AI) software named HIPPO automatically locates anatomical landmarks on anteroposterior pelvis radiographs and performs the needed measurements. The primary aim of this study was to assess the reliability of this tool as compared to multi-reader evaluation in clinically proven cases of adult HD. The secondary aims were to assess the time savings achieved and evaluate inter-reader assessment.

Methods

A consecutive preoperative sample of 130 HD patients (256 hips) was used. This cohort included 82.3% females (n = 107) and 17.7% males (n = 23) with median patient age of 28.6 years (interquartile range (IQR) 22.5 to 37.2). Three trained readers’ measurements were compared to AI outputs of lateral centre-edge angle (LCEA), caput-collum-diaphyseal (CCD) angle, pelvic obliquity, Tönnis angle, Sharp’s angle, and femoral head coverage. Intraclass correlation coefficients (ICC) and Bland-Altman analyses were obtained.


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.


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. 3, Issue 10 | Pages 786 - 794
12 Oct 2022
Harrison CJ Plummer OR Dawson J Jenkinson C Hunt A Rodrigues JN

Aims

The aim of this study was to develop and evaluate machine-learning-based computerized adaptive tests (CATs) for the Oxford Hip Score (OHS), Oxford Knee Score (OKS), Oxford Shoulder Score (OSS), and the Oxford Elbow Score (OES) and its subscales.

Methods

We developed CAT algorithms for the OHS, OKS, OSS, overall OES, and each of the OES subscales, using responses to the full-length questionnaires and a machine-learning technique called regression tree learning. The algorithms were evaluated through a series of simulation studies, in which they aimed to predict respondents’ full-length questionnaire scores from only a selection of their item responses. In each case, the total number of items used by the CAT algorithm was recorded and CAT scores were compared to full-length questionnaire scores by mean, SD, score distribution plots, Pearson’s correlation coefficient, intraclass correlation (ICC), and the Bland-Altman method. Differences between CAT scores and full-length questionnaire scores were contextualized through comparison to the instruments’ minimal clinically important difference (MCID).


Bone & Joint Open
Vol. 3, Issue 10 | Pages 777 - 785
10 Oct 2022
Kulkarni K Shah R Mangwani J Dias J

Aims

Deprivation underpins many societal and health inequalities. COVID-19 has exacerbated these disparities, with access to planned care falling greatest in the most deprived areas of the UK during 2020. This study aimed to identify the impact of deprivation on patients on growing waiting lists for planned care.

Methods

Questionnaires were sent to orthopaedic waiting list patients at the start of the UK’s first COVID-19 lockdown to capture key quantitative and qualitative aspects of patients’ health. A total of 888 respondents were divided into quintiles, with sampling stratified based on the Index of Multiple Deprivation (IMD); level 1 represented the ‘most deprived’ cohort and level 5 the ‘least deprived’.


Bone & Joint Open
Vol. 3, Issue 5 | Pages 404 - 414
9 May 2022
McGuire MF Vakulenko-Lagun B Millis MB Almakias R Cole EP Kim HKW

Aims

Perthes’ disease is an uncommon hip disorder with limited data on the long-term outcomes in adulthood. We partnered with community-based foundations and utilized web-based survey methodology to develop the Adult Perthes Survey, which includes demographics, childhood and adult Perthes’ disease history, the University of California Los Angeles (UCLA) Activity Scale item, Short Form-36, the Hip disability and Osteoarthritis Outcome Score, and a body pain diagram. Here we investigate the following questions: 1) what is the feasibility of obtaining > 1,000 survey responses from adults who had Perthes’ disease using a web-based platform?; and 2) what are the baseline characteristics and demographic composition of our sample?

Methods

The survey link was available publicly for 15 months and advertised among support groups. Of 1,505 participants who attempted the Adult Perthes survey, 1,182 completed it with a median timeframe of 11 minutes (IQR 8.633 to 14.72). Participants who dropped out were similar to those who completed the survey on several fixed variables. Participants represented 45 countries including the USA (n = 570; 48%), UK (n = 295; 25%), Australia (n = 133; 11%), and Canada (n = 46; 4%). Of the 1,182 respondents, 58% were female and the mean age was 39 years (SD 12.6).


Bone & Joint Open
Vol. 2, Issue 6 | Pages 359 - 364
1 Jun 2021
Papiez K Tutton E Phelps EE Baird J Costa ML Achten J Gibson P Perry DC

Aims

The aim of this study was to explore parents and young people’s experience of having a medial epicondyle fracture, and their thoughts about the uncertainty regarding the optimal treatment.

Methods

Families were identified after being invited to participate in a randomized controlled trial of surgery or no surgery for displaced medial epicondyle fractures of the humerus in children. A purposeful sample of 25 parents (22 females) and five young people (three females, mean age 11 years (7 to 14)) from 15 UK hospitals were interviewed a mean of 39 days (14 to 78) from injury. Qualitative interviews were informed by phenomenology and themes identified to convey participants’ experience.


Bone & Joint Open
Vol. 2, Issue 2 | Pages 111 - 118
8 Feb 2021
Pettit M Shukla S Zhang J Sunil Kumar KH Khanduja V

Aims

The ongoing COVID-19 pandemic has disrupted and delayed medical and surgical examinations where attendance is required in person. Our article aims to outline the validity of online assessment, the range of benefits to both candidate and assessor, and the challenges to its implementation. In addition, we propose pragmatic suggestions for its introduction into medical assessment.

Methods

We reviewed the literature concerning the present status of online medical and surgical assessment to establish the perceived benefits, limitations, and potential problems with this method of assessment.


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.


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.


Bone & Joint Open
Vol. 2, Issue 6 | Pages 380 - 387
1 Jun 2021
MacDonald DJ Clement ND Howie CR Scott CEH

Aims

The primary aim was to assess the patient-perceived effect of restrictions imposed due to COVID-19 on rehabilitation following total hip arthroplasty (THA) and total knee arthroplasty (TKA). Secondary aims were to assess perceived restrictions, influence on mental health, and functional outcome compared to patients undergoing surgery without restriction.

Methods

During February and March 2020, 105 patients underwent THA (n = 48) or TKA (n = 57) and completed preoperative and six-month postoperative assessments. A cohort of 415 patients undergoing surgery in 2019 were used as the control. Patient demographic data, BMI, comorbidities, Oxford Hip Score (OHS) or Knee Score (OKS), and EuroQoL five-domain (EQ-5D) score were collected preoperatively and at six months postoperatively. At six months postoperatively, the 2020 patients were also asked to complete a questionnaire relating to the effect of the social restrictions on their outcome and their mental health.


Bone & Joint Open
Vol. 1, Issue 6 | Pages 272 - 280
19 Jun 2020
King D Emara AK Ng MK Evans PJ Estes K Spindler KP Mroz T Patterson BM Krebs VE Pinney S Piuzzi NS Schaffer JL

Virtual encounters have experienced an exponential rise amid the current COVID-19 crisis. This abrupt change, seen in response to unprecedented medical and environmental challenges, has been forced upon the orthopaedic community. However, such changes to adopting virtual care and technology were already in the evolution forecast, albeit in an unpredictable timetable impeded by regulatory and financial barriers. This adoption is not meant to replace, but rather augment established, traditional models of care while ensuring patient/provider safety, especially during the pandemic. While our department, like those of other institutions, has performed virtual care for several years, it represented a small fraction of daily care. The pandemic required an accelerated and comprehensive approach to the new reality. Contemporary literature has already shown equivalent safety and patient satisfaction, as well as superior efficiency and reduced expenses with musculoskeletal virtual care (MSKVC) versus traditional models. Nevertheless, current literature detailing operational models of MSKVC is scarce. The current review describes our pre-pandemic MSKVC model and the shift to a MSKVC pandemic workflow that enumerates the conceptual workflow organization (patient triage, from timely care provision based on symptom acuity/severity to a continuum that includes future follow-up). Furthermore, specific setup requirements (both resource/personnel requirements such as hardware, software, and network connectivity requirements, and patient/provider characteristics respectively), and professional expectations are outlined. MSKVC has already become a pivotal element of musculoskeletal care, due to COVID-19, and these changes are confidently here to stay. Readiness to adapt and evolve will be required of individual musculoskeletal clinical teams as well as organizations, as established paradigms evolve.

Cite this article: Bone Joint Open 2020;1-6:272–280.


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.