Advertisement for orthosearch.org.uk
Results 1 - 50 of 114
Results per page:
Bone & Joint Open
Vol. 3, Issue 10 | Pages 753 - 758
4 Oct 2022
Farrow L Clement ND Smith D Meek DRM Ryan M Gillies K Anderson L Ashcroft GP

Aims. The extended wait that most patients are now experiencing for hip and knee arthroplasty has raised questions about whether reliance on waiting time as the primary driver for prioritization is ethical, and if other additional factors should be included in determining surgical priority. Our Prioritization of THose aWaiting hip and knee ArthroplastY (PATHWAY) project will explore which perioperative factors are important to consider when prioritizing those on the waiting list for hip and knee arthroplasty, and how these factors should be weighted. The final product will include a weighted benefit score that can be used to aid in surgical prioritization for those awaiting elective primary hip and knee arthroplasty. Methods. There will be two linked work packages focusing on opinion from key stakeholders (patients and surgeons). First, an online modified Delphi process to determine a consensus set of factors that should be involved in patient prioritization. This will be performed using standard Delphi methodology consisting of multiple rounds where following initial individual rating there is feedback, discussion, and further recommendations undertaken towards eventual consensus. The second stage will then consist of a Discrete Choice Experiment (DCE) to allow for priority setting of the factors derived from the Delphi through elicitation of weighted benefit scores. The DCE consists of several choice tasks designed to elicit stakeholder preference regarding included attributes (factors). Results. The study is co-funded by the University of Aberdeen Knowledge Exchange Commission (Ref CF10693-29) and a Chief Scientist Office (CSO) Scotland Clinical Research Fellowship which runs from 08/2021 to 08/2024 (Grant ref: CAF/21/06). Approval from the University of Aberdeen Institute of Applied Health Sciences School Ethics Review Board was granted 22/03/2022 - Reference number SERB/2021/12/2210. Conclusion. The PATHWAY project provides the first attempt to use patient and surgeon opinions to develop a unified approach to prioritization for those awaiting hip and knee arthroplasty. Development of such a tool will provide more equitable access to arthroplasty services, as well as providing a framework for developing similar approaches in other areas of healthcare delivery. Cite this article: Bone Jt Open 2022;3(10):753–758


Bone & Joint Open
Vol. 5, Issue 11 | Pages 984 - 991
6 Nov 2024
Molloy T Gompels B McDonnell S

Aims. This Delphi study assessed the challenges of diagnosing soft-tissue knee injuries (STKIs) in acute settings among orthopaedic healthcare stakeholders. Methods. This modified e-Delphi study consisted of three rounds and involved 32 orthopaedic healthcare stakeholders, including physiotherapists, emergency nurse practitioners, sports medicine physicians, radiologists, orthopaedic registrars, and orthopaedic consultants. The perceived importance of diagnostic components relevant to STKIs included patient and external risk factors, clinical signs and symptoms, special clinical tests, and diagnostic imaging methods. Each round required scoring and ranking various items on a ten-point Likert scale. The items were refined as each round progressed. The study produced rankings of perceived importance across the various diagnostic components. Results. In Round 1, the study revealed widespread variability in stakeholder opinions on diagnostic components of STKIs. Round 2 identified patterns in the perceived importance of specific items within each diagnostic component. Round 3 produced rankings of perceived item importance within each diagnostic component. Noteworthy findings include the challenges associated with accurate and readily available diagnostic methods in acute care settings, the consistent acknowledgment of the importance of adopting a patient-centred approach to diagnosis, and the transition from divergent to convergent opinions between Rounds 2 and 3. Conclusion. This study highlights the potential for a paradigm shift in acute STKI diagnosis, where variability in the understanding of STKI diagnostic components may be addressed by establishing a uniform, evidence-based framework for evaluating these injuries. Cite this article: Bone Jt Open 2024;5(11):984–991


The Bone & Joint Journal
Vol. 103-B, Issue 8 | Pages 1328 - 1330
1 Aug 2021
Gwilym SE Perry DC Costa ML


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 1016 - 1020
9 Jul 2024
Trompeter AJ Costa ML

Aims. Weightbearing instructions after musculoskeletal injury or orthopaedic surgery are a key aspect of the rehabilitation pathway and prescription. The terminology used to describe the weightbearing status of the patient is variable; many different terms are used, and there is recognition and evidence that the lack of standardized terminology contributes to confusion in practice. Methods. A consensus exercise was conducted involving all the major stakeholders in the patient journey for those with musculoskeletal injury. The consensus exercise primary aim was to seek agreement on a standardized set of terminology for weightbearing instructions. Results. A pre-meeting questionnaire was conducted. The one-day consensus meeting, including patient representatives, identified three agreed terms only to be used in defining the weightbearing status of the patient: 1) non-weightbearing; 2) limited weightbearing; and 3) unrestricted weightbearing. Conclusion. This study represents the first and only exercise in standardizing rehabilitation terminology in orthopaedics, as agreed by all major stakeholders in the patient pathway and the patients themselves. The standardization of language allows for higher-quality and more accurate research to be conducted, and is one small part of the bigger picture in increasing the mobility of patients after orthopaedic injury or surgery. Cite this article: Bone Joint J 2024;106-B(9):1016–1020


Bone & Joint Research
Vol. 12, Issue 4 | Pages 294 - 305
20 Apr 2023
Aquilina AL Claireaux H Aquilina CO Tutton E Fitzpatrick R Costa ML Griffin XL

Aims. Open lower limb fracture is life-changing, resulting in substantial morbidity and resource demand, while inconsistent outcome-reporting hampers systematic review and meta-analysis. A core outcome set establishes consensus among key stakeholders for the recommendation of a minimum set of outcomes. This study aims to define a core outcome set for adult open lower limb fracture. Methods. Candidate outcomes were identified from a previously published systematic review and a secondary thematic analysis of 25 patient interviews exploring the lived experience of recovery from open lower limb fracture. Outcomes were categorized and sequentially refined using healthcare professional and patient structured discussion groups. Consensus methods included a multi-stakeholder two-round online Delphi survey and a consensus meeting attended by a purposive sample of stakeholders, facilitated discussion, and voting using a nominal group technique. Results. Thematic analysis and systematic review identified 121 unique outcomes, reduced to 68 outcomes following structured discussion groups. Outcomes were presented to 136 participants who completed a two-round online Delphi survey. The Delphi survey resulted in 11 outcomes identified as consensus ‘in’ only. All outcomes were discussed at a consensus meeting attended by 15 patients, 14 healthcare professionals, 11 researchers, and one patient-carer. Consensus was achieved for a four-core outcome set: ‘Walking, gait and mobility’, ‘Being able to return to life roles’, ‘Pain or discomfort’, and ‘Quality of life’. Conclusion. This study used robust consensus methods to establish a core outcome set that should be measured in all future research studies and audits of clinical practice without precluding the measurement of additional outcomes. Cite this article: Bone Joint Res 2023;12(4):294–305


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

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


Bone & Joint Open
Vol. 4, Issue 2 | Pages 87 - 95
10 Feb 2023
Deshmukh SR Kirkham JJ Karantana A

Aims. The aim of this study was to develop a core outcome set of what to measure in all future clinical research on hand fractures and joint injuries in adults. Methods. Phase 1 consisted of steps to identify potential outcome domains through systematic review of published studies, and exploration of the patient perspective through qualitative research, consisting of 25 semi-structured interviews and five focus groups. Phase 2 involved key stakeholder groups (patients, hand surgeons, and hand therapists) prioritizing the outcome domains via a three-round international Delphi survey, with a final consensus meeting to agree the final core outcome set. Results. The systematic review of 160 studies identified 74 outcome domains based on the World Health Organization International Classification of Functioning, Disability, and Health. Overall, 35 domains were generated through thematic analysis of the patient interviews and focus groups. The domains from these elements were synthesised to develop 37 outcome domains as the basis of the Delphi survey, with a further four generated from participant suggestions in Round 1. The Delphi survey identified 20 outcome domains as ‘very important’ for the core outcome set. At the consensus meeting, 27 participants from key stakeholder groups selected seven outcomes for the core outcome set: pain/discomfort with activity, pain/discomfort with rest, fine hand use/dexterity, self-hygiene/personal care, return to usual work/job, range of motion, and patient satisfaction with outcome/result. Conclusion. This set of core outcome domains is recommended as a minimum to be reported in all clinical research on hand fractures and joint injuries in adults. While this establishes what to measure, future work will focus on determining how best to measure these outcomes. By adopting this patient-centred core outcome set, consistency and comparability of studies will be improved, aiding meta-analysis and strengthening the evidence base for management of these common and impactful injuries. Cite this article: Bone Jt Open 2023;4(2):87–95


Bone & Joint Open
Vol. 3, Issue 1 | Pages 54 - 60
14 Jan 2022
Leo DG Green G Eastwood DM Bridgens A Gelfer Y

Aims. The aim of this study is to define a core outcome set (COS) to allow consistency in outcome reporting amongst studies investigating the management of orthopaedic treatment in children with spinal dysraphism (SD). Methods. Relevant outcomes will be identified in a four-stage process from both the literature and key stakeholders (patients, their families, and clinical professionals). Previous outcomes used in clinical studies will be identified through a systematic review of the literature, and each outcome will be assigned to one of the five core areas, defined by the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT). Additional possible outcomes will be identified through consultation with patients affected by SD and their families. Results. Outcomes identified in these stages will be included in a two-round Delphi process that will involve key stakeholders in the management of SD. A final list including the identified outcomes will then be summarized in a consensus meeting attended by representatives of the key stakeholders groups. Conclusion. The best approach to provision of orthopaedic care in patients with SD is yet to be decided. The reporting of different outcomes to define success among studies, often based on personal preferences and local culture, has made it difficult to compare the effect of treatments for this condition. The development of a COS for orthopaedic management in SD will enable meaningful reporting and facilitate comparisons in future clinical trials, thereby assisting complex decision-making in the clinical management of these children. Cite this article: Bone Jt Open 2022;3(1):54–60


Bone & Joint Open
Vol. 2, Issue 4 | Pages 255 - 260
15 Apr 2021
Leo DG Russell A Bridgens A Perry DC Eastwood DM Gelfer Y

Aims. This study aims to define a set of core outcomes (COS) to allow consistent reporting in order to compare results and assist in treatment decisions for idiopathic clubfoot. Methods. A list of outcomes will be obtained in a three-stage process from the literature and from key stakeholders (patients, parents, surgeons, and healthcare professionals). Important outcomes for patients and parents will be collected from a group of children with idiopathic clubfoot and their parents through questionnaires and interviews. The outcomes identified during this process will be combined with the list of outcomes previously obtained from a systematic review, with each outcome assigned to one of the five core areas defined by the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT). This stage will be followed by a two round Delphi survey aimed at key stakeholders in the management of idiopathic clubfoot. The final outcomes list obtained will then be discussed in a consensus meeting of representative key stakeholders. Conclusion. The inconsistency in outcomes reporting in studies investigating idiopathic clubfoot has made it difficult to define the success rate of treatments and to compare findings between studies. The development of a COS seeks to define a minimum standard set of outcomes to collect in all future clinical trials for this condition, to facilitate comparisons between studies and to aid decisions in treatment. Cite this article: Bone Jt Open 2021;2(4):255–260


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 422 - 424
1 May 2024
Theologis T Perry DC

In 2017, the British Society for Children’s Orthopaedic Surgery engaged the profession and all relevant stakeholders in two formal research prioritization processes. In this editorial, we describe the impact of this prioritization on funding, and how research in children’s orthopaedics, which was until very recently a largely unfunded and under-investigated area, is now flourishing. Establishing research priorities was a crucial step in this process. Cite this article: Bone Joint J 2024;106-B(5):422–424


Bone & Joint Research
Vol. 12, Issue 6 | Pages 352 - 361
1 Jun 2023
Aquilina AL Claireaux H Aquilina CO Tutton E Fitzpatrick R Costa ML Griffin XL

Aims. A core outcome set for adult, open lower limb fracture has been established consisting of ‘Walking, gait and mobility’, ‘Being able to return to life roles’, ‘Pain or discomfort’, and ‘Quality of life’. This study aims to identify which outcome measurement instruments (OMIs) should be recommended to measure each core outcome. Methods. A systematic review and quality assessment were conducted to identify existing instruments with evidence of good measurement properties in the open lower limb fracture population for each core outcome. Additionally, shortlisting criteria were developed to identify suitable instruments not validated in the target population. Candidate instruments were presented, discussed, and voted on at a consensus meeting of key stakeholders. Results. The Wales Lower Limb Trauma Recovery scale was identified, demonstrating validation evidence in the target population. In addition, ten candidate OMIs met the shortlisting criteria. Six patients, eight healthcare professionals, and 11 research methodologists attended the consensus meeting. Consensus was achieved for the EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and the Lower Extremity Functional Scale (LEFS) to measure ‘Quality of life’ and ‘Walking, gait and mobility’ in future research trials, audit, and clinical assessment, respectively. No instrument met consensus criteria to measure ‘Being able to return to life roles’ and ‘Pain or discomfort’. However, the EQ-5D-5L was found to demonstrate good face validity and could also be used pragmatically to measure these two outcomes, accepting limitations in sensitivity. Conclusion. This study recommends the LEFS and EQ-5D-5L to measure the core outcome set for adult open lower limb fracture. Cite this article: Bone Joint Res 2023;12(6):352–361


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. Results. Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion. Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required. Cite this article: Bone Jt Open 2022;3(10):832–840


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1821 - 1830
1 Dec 2021
Marson BA Manning JC James M Craxford S Deshmukh SR Perry DC Ollivere BJ

Aims. The aim of this study is to develop a core set of outcome domains that should be considered and reported in all future trials of childhood limb fractures. Methods. A four-phase study was conducted to agree a set of core outcome domains. Identification of candidate outcome domains were identified through systematic review of trials, and outcome domains relevant to families were identified through semi-structured interviews with 20 families (parent-child pairing or group). Outcome domains were prioritized using an international three-round Delphi survey with 205 panellists and then condensed into a core outcome set through a consensus workshop with 30 stakeholders. Results. The systematic review and interviews identified 85 outcome domains as relevant to professionals or families. The Delphi survey prioritized 30 upper and 29 lower limb outcome domains at first round, an additional 17 upper and 18 lower limb outcomes at second round, and four additional outcomes for upper and lower limb at the third round as important domains. At the consensus workshop, the core outcome domains were agreed as: 1) pain and discomfort; 2) return to physical and recreational activities; 3) emotional and psychosocial wellbeing; 4) complications from the injury and treatment; 5) rturn to baseline activities daily living; 6) participation in learning; 7) appearance and deformity; and 8) time to union. In addition, 9a) recovery of mobility and 9b) recovery of manual dexterity was recommended as a core outcome for lower and upper limb fractures, respectively. Conclusion. This set of core outcome domains is recommended as a minimum set of outcomes to be reported in all trials. It is not an exhaustive set and further work is required to identify what outcome tools should be used to measure each of these outcomes. Adoption of this outcome set will improve the consistency of research for these children that can be combined for more meaningful meta-analyses and policy development. Cite this article: Bone Joint J 2021;103-B(12):1821–1830


Bone & Joint Open
Vol. 3, Issue 1 | Pages 98 - 106
27 Jan 2022
Gelfer Y Leo DG Russell A Bridgens A Perry DC Eastwood DM

Aims. To identify the minimum set of outcomes that should be collected in clinical practice and reported in research related to the care of children with idiopathic congenital talipes equinovarus (CTEV). Methods. A list of outcome measurement tools (OMTs) was obtained from the literature through a systematic review. Further outcomes were collected from patients and families through a questionnaire and interview process. The combined list, as well as the appropriate follow-up timepoint, was rated for importance in a two-round Delphi process that included an international group of orthopaedic surgeons, physiotherapists, nurse practitioners, patients, and families. Outcomes that reached no consensus during the Delphi process were further discussed and scored for inclusion/exclusion in a final consensus meeting involving international stakeholder representatives of practitioners, families, and patient charities. Results. In total, 39 OMTs were included from the systematic review. Two additional OMTs were identified from the interviews and questionnaires, and four were added after round one Delphi. Overall, 22 OMTs reached ‘consensus in’ during the Delphi and two reached ‘consensus out’; 21 OMTs reached ‘no consensus’ and were included in the final consensus meeting. In all, 21 participants attended the consensus meeting, including a wide diversity of clubfoot practitioners, parent/patient representative, and an independent chair. A total of 21 outcomes were discussed and voted upon; six were voted ‘in’ and 15 were voted ‘out’. The final COS document includes nine OMTs and two existing outcome scores with a total of 31 outcome parameters to be collected after a minimum follow-up of five years. It incorporates static and dynamic clinical findings, patient-reported outcome measures, and a definition of CTEV relapse. Conclusion. We have defined a minimum set of outcomes to draw comparisons between centres and studies in the treatment of CTEV. With the use of these outcomes, we hope to allow more meaningful research and a better clinical management of CTEV. Cite this article: Bone Jt Open 2022;3(1):98–106


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 5 - 10
1 Jan 2020
Cawley DT Rajamani V Cawley M Selvadurai S Gibson A Molloy S

Aims. Intraoperative 3D navigation (ION) allows high accuracy to be achieved in spinal surgery, but poor workflow has prevented its widespread uptake. The technical demands on ION when used in patients with adolescent idiopathic scoliosis (AIS) are higher than for other more established indications. Lean principles have been applied to industry and to health care with good effects. While ensuring optimal accuracy of instrumentation and safety, the implementation of ION and its associated productivity was evaluated in this study for AIS surgery in order to enhance the workflow of this technique. The aim was to optimize the use of ION by the application of lean principles in AIS surgery. Methods. A total of 20 consecutive patients with AIS were treated with ION corrective spinal surgery. Both qualitative and quantitative analysis was performed with real-time modifications. Operating time, scan time, dose length product (measure of CT radiation exposure), use of fluoroscopy, the influence of the reference frame, blood loss, and neuromonitoring were assessed. Results. The greatest gains in productivity were in avoiding repeat intraoperative scans (a mean of 248 minutes for patients who had two scans, and a mean 180 minutes for those who had a single scan). Optimizing accuracy was the biggest factor influencing this, which was reliant on incremental changes to the operating setup and technique. Conclusion. The application of lean principles to the introduction of ION for AIS surgery helps assimilate this method into the environment of the operating theatre. Data and stakeholder analysis identified a reproducible technique for using ION for AIS surgery, reducing operating time, and radiation exposure. Cite this article: Bone Joint J. 2020;102-B(1):5–10


Bone & Joint Open
Vol. 4, Issue 4 | Pages 226 - 233
1 Apr 2023
Moore AJ Wylde V Whitehouse MR Beswick AD Walsh NE Jameson C Blom AW

Aims

Periprosthetic hip-joint infection is a multifaceted and highly detrimental outcome for patients and clinicians. The incidence of prosthetic joint infection reported within two years of primary hip arthroplasty ranges from 0.8% to 2.1%. Costs of treatment are over five-times greater in people with periprosthetic hip joint infection than in those with no infection. Currently, there are no national evidence-based guidelines for treatment and management of this condition to guide clinical practice or to inform clinical study design. The aim of this study is to develop guidelines based on evidence from the six-year INFection and ORthopaedic Management (INFORM) research programme.

Methods

We used a consensus process consisting of an evidence review to generate items for the guidelines and online consensus questionnaire and virtual face-to-face consensus meeting to draft the guidelines.


Objectives. The annual incidence of hip fracture is 620 000 in the European Union. The cost of this clinical problem has been estimated at 1.75 million disability-adjusted life years lost, equating to 1.4% of the total healthcare burden in established market economies. Recent guidance from The National Institute for Health and Clinical Excellence (NICE) states that research into the clinical and cost effectiveness of total hip arthroplasty (THA) as a treatment for hip fracture is a priority. We asked the question: can a trial investigating THA for hip fracture currently be delivered in the NHS?. Methods. We performed a contemporaneous process evaluation that provides a context for the interpretation of the findings of WHiTE Two – a randomised study of THA for hip fracture. We developed a mixed methods approach to situate the trial centre within the context of wider United Kingdom clinical practice. We focused on fidelity, implementation, acceptability and feasibility of both the trial processes and interventions to stakeholder groups, such as healthcare providers and patients. Results. We have shown that patients are willing to participate in this type of research and that surgeons value being part of a team that has a strong research ethos. However, surgical practice does not currently reflect NICE guidance. Current models of service delivery for hip fractures are unlikely to be able to provide timely total hip arthroplasty for suitable patients. Conclusions. Further observational research should be conducted to define the population of interest before future interventional studies are performed. Cite this article: C. Huxley, J. Achten, M. L. Costa, F. Griffiths, X. L. Griffin. A process evaluation of the WHiTE Two trial comparing total hip arthroplasty with and without dual mobility component in the treatment of displaced intracapsular fractures of the proximal femur: Can a trial investigating total hip arthroplasty for hip fracture be delivered in the NHS? Bone Joint Res 2016;5:444–452. DOI: 10.1302/2046-3758.510.BJR-2015-0008.R1


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 343 - 346
15 Mar 2023
Murray IR Makaram NS LaPrade RF Haddad FS

The Bone & Joint Journal has published several consensus statements in recent years, many of which have positively influenced clinical practice and policy.1-13 However, even the most valued consensus statements have limitations, and all ultimately represent Level V evidence. Consensus studies add greatest value where higher-order evidence to aid decision making is ambiguous or lacking. In all settings, care must be taken to critically appraise standards of methodology, with particular attention to potential biases that may influence the conclusions which are drawn.

Cite this article: Bone Joint J 2023;105-B(4):343–346.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1306 - 1311
1 Nov 2024
Watts AC McDaid C Hewitt C

Aims

A review of the literature on elbow replacement found no consistency in the clinical outcome measures which are used to assess the effectiveness of interventions. The aim of this study was to define core outcome domains for elbow replacement.

Methods

A real-time Delphi survey was conducted over four weeks using outcomes from a scoping review of 362 studies on elbow replacement published between January 1990 and February 2021. A total of 583 outcome descriptors were rationalized to 139 unique outcomes. The survey consisted of 139 outcomes divided into 18 domains. The readability and clarity of the survey was determined by an advisory group including a patient representative. Participants were able to view aggregated responses from other participants in real time and to revisit their responses as many times as they wished during the study period. Participants were able to propose additional items for inclusion. A Patient and Public Inclusion and Engagement (PPIE) panel considered the consensus findings.


Bone & Joint Open
Vol. 4, Issue 2 | Pages 72 - 78
9 Feb 2023
Kingsbury SR Smith LKK Pinedo-Villanueva R Judge A West R Wright JM Stone MH Conaghan PG

Aims

To review the evidence and reach consensus on recommendations for follow-up after total hip and knee arthroplasty.

Methods

A programme of work was conducted, including: a systematic review of the clinical and cost-effectiveness literature; analysis of routine national datasets to identify pre-, peri-, and postoperative predictors of mid-to-late term revision; prospective data analyses from 560 patients to understand how patients present for revision surgery; qualitative interviews with NHS managers and orthopaedic surgeons; and health economic modelling. Finally, a consensus meeting considered all the work and agreed the final recommendations and research areas.


The Bone & Joint Journal
Vol. 106-B, Issue 3 | Pages 232 - 239
1 Mar 2024
Osmani HT Nicolaou N Anand S Gower J Metcalfe A McDonnell S

Aims

To identify unanswered questions about the prevention, diagnosis, treatment, and rehabilitation and delivery of care of first-time soft-tissue knee injuries (ligament injuries, patella dislocations, meniscal injuries, and articular cartilage) in children (aged 12 years and older) and adults.

Methods

The James Lind Alliance (JLA) methodology for Priority Setting Partnerships was followed. An initial survey invited patients and healthcare professionals from the UK to submit any uncertainties regarding soft-tissue knee injury prevention, diagnosis, treatment, and rehabilitation and delivery of care. Over 1,000 questions were received. From these, 74 questions (identifying common concerns) were formulated and checked against the best available evidence. An interim survey was then conducted and 27 questions were taken forward to the final workshop, held in January 2023, where they were discussed, ranked, and scored in multiple rounds of prioritization. This was conducted by healthcare professionals, patients, and carers.


Bone & Joint Research
Vol. 13, Issue 9 | Pages 507 - 512
18 Sep 2024
Farrow L Meek D Leontidis G Campbell M Harrison E Anderson L

Despite the vast quantities of published artificial intelligence (AI) algorithms that target trauma and orthopaedic applications, very few progress to inform clinical practice. One key reason for this is the lack of a clear pathway from development to deployment. In order to assist with this process, we have developed the Clinical Practice Integration of Artificial Intelligence (CPI-AI) framework – a five-stage approach to the clinical practice adoption of AI in the setting of trauma and orthopaedics, based on the IDEAL principles (https://www.ideal-collaboration.net/). Adherence to the framework would provide a robust evidence-based mechanism for developing trust in AI applications, where the underlying algorithms are unlikely to be fully understood by clinical teams.

Cite this article: Bone Joint Res 2024;13(9):507–512.


Bone & Joint 360
Vol. 12, Issue 5 | Pages 6 - 10
1 Oct 2023
Arnaouti M


Bone & Joint Open
Vol. 4, Issue 10 | Pages 735 - 741
2 Oct 2023
Galloway AM Pini S Holton C Perry DC Redmond A Siddle HJ Richards S

Aims

Perthes’ disease is an idiopathic avascular necrosis of the developing femoral head, often causing deformity that impairs physical function. Current treatments aim to optimize the joint reaction force across the hip by enhancing congruency between the acetabulum and femoral head. Despite a century of research, there is no consensus regarding the optimal treatment. The aim of this study was to describe the experiences of children, their families, and clinicians when considering the treatment of Perthes’ disease.

Methods

A qualitative study gathered information from children and their families affected by Perthes’ disease, along with treating clinicians. Interviews followed a coding framework, with the interview schedule informed by behavioural theory and patient and public involvement. Transcripts were analyzed using the framework method.


Bone & Joint Research
Vol. 12, Issue 2 | Pages 138 - 146
14 Feb 2023
Aquilina AL Claireaux H Aquilina CO Tutton E Fitzpatrick R Costa ML Griffin XL

Aims

Open lower limb fracture is a life-changing injury affecting 11.5 per 100,000 adults each year, and causes significant morbidity and resource demand on trauma infrastructures. This study aims to identify what, and how, outcomes have been reported for people following open lower limb fracture over ten years.

Methods

Systematic literature searches identified all clinical studies reporting outcomes for adults following open lower limb fracture between January 2009 and July 2019. All outcomes and outcome measurement instruments were extracted verbatim. An iterative process was used to group outcome terms under standardized outcome headings categorized using an outcome taxonomy.


Bone & Joint Open
Vol. 5, Issue 5 | Pages 411 - 418
20 May 2024
Schneider P Bajammal S Leighton R Witges K Rondeau K Duffy P

Aims

Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures.

Methods

This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury.


The Bone & Joint Journal
Vol. 106-B, Issue 3 | Pages 277 - 285
1 Mar 2024
Pinto D Hussain S Leo DG Bridgens A Eastwood D Gelfer Y

Aims

Children with spinal dysraphism can develop various musculoskeletal deformities, necessitating a range of orthopaedic interventions, causing significant morbidity, and making considerable demands on resources. This systematic review aimed to identify what outcome measures have been reported in the literature for children with spinal dysraphism who undergo orthopaedic interventions involving the lower limbs.

Methods

A PROSPERO-registered systematic literature review was performed following PRISMA guidelines. All relevant studies published until January 2023 were identified. Individual outcomes and outcome measurement tools were extracted verbatim. The measurement tools were assessed for reliability and validity, and all outcomes were grouped according to the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT) filters.


Bone & Joint Open
Vol. 3, Issue 7 | Pages 549 - 556
1 Jul 2022
Poacher AT Bhachoo H Weston J Shergill K Poacher G Froud J

Aims

Evidence exists of a consistent decline in the value and time that medical schools place upon their undergraduate orthopaedic placements. This limited exposure to trauma and orthopaedics (T&O) during medical school will be the only experience in the speciality for the majority of doctors. This review aims to provide an overview of undergraduate orthopaedic training in the UK.

Methods

This review summarizes the relevant literature from the last 20 years in the UK. Articles were selected from database searches using MEDLINE, EMBASE, ERIC, Cochrane, and Web of Science. A total of 16 papers met the inclusion criteria.


Bone & Joint 360
Vol. 11, Issue 5 | Pages 39 - 42
1 Oct 2022


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1199 - 1202
1 Nov 2024
Watts AC Tennent TD Haddad FS


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 303 - 306
1 Apr 2024
Staats K Kayani B Haddad FS


The Bone & Joint Journal
Vol. 105-B, Issue 1 | Pages 17 - 20
1 Jan 2023
Petrou S Png ME Metcalfe D

Economic evaluation provides a framework for assessing the costs and consequences of alternative programmes or interventions. One common vehicle for economic evaluations in the healthcare context is the decision-analytic model, which synthesizes information on parameter inputs (for example, probabilities or costs of clinical events or health states) from multiple sources and requires application of mathematical techniques, usually within a software program. A plethora of decision-analytic modelling-based economic evaluations of orthopaedic interventions have been published in recent years. This annotation outlines a number of issues that can help readers, reviewers, and decision-makers interpret evidence from decision-analytic modelling-based economic evaluations of orthopaedic interventions.

Cite this article: Bone Joint J 2023;105-B(1):17–20.


Aims

The purpose of this study was to assess the reliability and responsiveness to hip surgery of a four-point modified Care and Comfort Hypertonicity Questionnaire (mCCHQ) scoring tool in children with cerebral palsy (CP) in Gross Motor Function Classification System (GMFCS) levels IV and V.

Methods

This was a population-based cohort study in children with CP from a national surveillance programme. Reliability was assessed from 20 caregivers who completed the mCCHQ questionnaire on two occasions three weeks apart. Test-retest reliability of the mCCHQ was calculated, and responsiveness before and after surgery for a displaced hip was evaluated in a cohort of children.


The Bone & Joint Journal
Vol. 105-B, Issue 6 | Pages 711 - 716
1 Jun 2023
Ali MS Khattak M Metcalfe D Perry DC

Aims

This study aimed to evaluate the relationship between hip shape and mid-term function in Perthes’ disease. It also explored whether the modified three-group Stulberg classification can offer similar prognostic information to the five-group system.

Methods

A total of 136 individuals aged 12 years or older who had Perthes’ disease in childhood completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Mobility score (function), Nonarthritic Hip Score (NAHS) (function), EuroQol five-dimension five-level questionnaire (EQ-5D-5L) score (quality of life), and the numeric rating scale for pain (NRS). The Stulberg class of the participants’ hip radiographs were evaluated by three fellowship-trained paediatric orthopaedic surgeons. Hip shape and Stulberg class were compared to PROM scores.


Bone & Joint 360
Vol. 12, Issue 4 | Pages 6 - 9
1 Aug 2023
Craxford S Marson BA Ollivere B


Bone & Joint Open
Vol. 5, Issue 3 | Pages 236 - 242
22 Mar 2024
Guryel E McEwan J Qureshi AA Robertson A Ahluwalia R

Aims

Ankle fractures are common injuries and the third most common fragility fracture. In all, 40% of ankle fractures in the frail are open and represent a complex clinical scenario, with morbidity and mortality rates similar to hip fracture patients. They have a higher risk of complications, such as wound infections, malunion, hospital-acquired infections, pressure sores, veno-thromboembolic events, and significant sarcopaenia from prolonged bed rest.

Methods

A modified Delphi method was used and a group of experts with a vested interest in best practice were invited from the British Foot and Ankle Society (BOFAS), British Orthopaedic Association (BOA), Orthopaedic Trauma Society (OTS), British Association of Plastic & Reconstructive Surgeons (BAPRAS), British Geriatric Society (BGS), and the British Limb Reconstruction Society (BLRS).


Bone & Joint 360
Vol. 12, Issue 2 | Pages 16 - 19
1 Apr 2023

The April 2023 Knee Roundup360 looks at: Does bariatric surgery reduce complications after total knee arthroplasty?; Mid-flexion stability in total knee arthroplasties implanted with kinematic alignment: posterior-stabilized versus medial-stabilized implants; Inflammatory response in robotic-arm-assisted versus conventional jig-based total knee arthroplasty; Journey II bicruciate stabilized (JII-BCS) and GENESIS II total knee arthroplasty: the CAPAbility, blinded, randomized controlled trial; Lifetime risk of revision and patient factors; Platelet-rich plasma use for hip and knee osteoarthritis in the USA; Where have the knee revisions gone?; Tibial component rotation in total knee arthroplasty: CT-based study of 1,351 tibiae.


Bone & Joint Open
Vol. 5, Issue 10 | Pages 904 - 910
18 Oct 2024
Bergman EM Mulligan EP Patel RM Wells J

Aims

The Single Assessment Numerical Evalution (SANE) score is a pragmatic alternative to longer patient-reported outcome measures (PROMs). The purpose of this study was to investigate the concurrent validity of the SANE and hip-specific PROMs in a generalized population of patients with hip pain at a single timepoint upon initial visit with an orthopaedic surgeon who is a hip preservation specialist. We hypothesized that SANE would have a strong correlation with the 12-question International Hip Outcome Tool (iHOT)-12, the Hip Outcome Score (HOS), and the Hip disability and Osteoarthritis Outcome Score (HOOS), providing evidence for concurrent validity of the SANE and hip-specific outcome measures in patients with hip pain.

Methods

This study was a cross-sectional retrospective database analysis at a single timepoint. Data were collected from 2,782 patients at initial evaluation with a hip preservation specialist using the iHOT-12, HOS, HOOS, and SANE. Outcome scores were retrospectively analyzed using Pearson correlation coefficients.


Bone & Joint Open
Vol. 5, Issue 8 | Pages 708 - 714
22 Aug 2024
Mikhail M Riley N Rodrigues J Carr E Horton R Beale N Beard DJ Dean BJF

Aims

Complete ruptures of the ulnar collateral ligament (UCL) of the thumb are a common injury, yet little is known about their current management in the UK. The objective of this study was to assess the way complete UCL ruptures are managed in the UK.

Methods

We carried out a multicentre, survey-based cross-sectional study in 37 UK centres over a 16-month period from June 2022 to September 2023. The survey results were analyzed descriptively.


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 843 - 849
1 Aug 2023
Grandhi TSP Fontalis A Raj RD Kim WJ Giebaly DE Haddad FS

Telehealth has the potential to change the way we approach patient care. From virtual consenting to reducing carbon emissions, costs, and waiting times, it is a powerful tool in our clinical armamentarium. There is mounting evidence that remote diagnostic evaluation and decision-making have reached an acceptable level of accuracy and can safely be adopted in orthopaedic surgery. Furthermore, patients’ and surgeons’ satisfaction with virtual appointments are comparable to in-person consultations. Challenges to the widespread use of telehealth should, however, be acknowledged and include the cost of installation, training, maintenance, and accessibility. It is also vital that clinicians are conscious of the medicolegal and ethical considerations surrounding the medium and adhere strictly to the relevant data protection legislation and storage framework. It remains to be seen how organizations harness the full spectrum of the technology to facilitate effective patient care.

Cite this article: Bone Joint J 2023;105-B(8):843–849.


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 501 - 507
1 May 2024
Galloway AM Keene DJ Anderson A Holton C Redmond AC Siddle HJ Richards S Perry DC

Aims

The aim of this study was to produce clinical consensus recommendations about the non-surgical treatment of children with Perthes’ disease. The recommendations are intended to support clinical practice in a condition for which there is no robust evidence to guide optimal care.

Methods

A two-round, modified Delphi study was conducted online. An advisory group of children’s orthopaedic specialists consisting of physiotherapists, surgeons, and clinical nurse specialists designed a survey. In the first round, participants also had the opportunity to suggest new statements. The survey included statements related to ‘Exercises’, ‘Physical activity’, ‘Education/information sharing’, ‘Input from other services’, and ‘Monitoring assessments’. The survey was shared with clinicians who regularly treat children with Perthes’ disease in the UK using clinically relevant specialist groups and social media. A predetermined threshold of ≥ 75% for consensus was used for recommendation, with a threshold of between 70% and 75% being considered as ‘points to consider’.


Bone & Joint 360
Vol. 12, Issue 6 | Pages 6 - 12
1 Dec 2023
Vallier HA Breslin MA Taylor LA Hendrickson SB Ollivere B


The Bone & Joint Journal
Vol. 106-B, Issue 1 | Pages 69 - 76
1 Jan 2024
Tucker A Roffey DM Guy P Potter JM Broekhuyse HM Lefaivre KA

Aims

Acetabular fractures are associated with long-term morbidity. Our prospective cohort study sought to understand the recovery trajectory of this injury over five years.

Methods

Eligible patients at a level I trauma centre were recruited into a longitudinal registry of surgical acetabular fractures between June 2004 and August 2019. Patient-reported outcome measures (PROMs), including the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS), were recorded at baseline pre-injury recall and six months, one year, two years, and five years postoperatively. Comparative analyses were performed for elementary and associated fracture patterns. The proportion of patients achieving minimal clinically important difference (MCID) was determined. The rate of, and time to, conversion to total hip arthroplasty (THA) was also established.


Bone & Joint Research
Vol. 12, Issue 7 | Pages 447 - 454
10 Jul 2023
Lisacek-Kiosoglous AB Powling AS Fontalis A Gabr A Mazomenos E Haddad FS

The use of artificial intelligence (AI) is rapidly growing across many domains, of which the medical field is no exception. AI is an umbrella term defining the practical application of algorithms to generate useful output, without the need of human cognition. Owing to the expanding volume of patient information collected, known as ‘big data’, AI is showing promise as a useful tool in healthcare research and across all aspects of patient care pathways. Practical applications in orthopaedic surgery include: diagnostics, such as fracture recognition and tumour detection; predictive models of clinical and patient-reported outcome measures, such as calculating mortality rates and length of hospital stay; and real-time rehabilitation monitoring and surgical training. However, clinicians should remain cognizant of AI’s limitations, as the development of robust reporting and validation frameworks is of paramount importance to prevent avoidable errors and biases. The aim of this review article is to provide a comprehensive understanding of AI and its subfields, as well as to delineate its existing clinical applications in trauma and orthopaedic surgery. Furthermore, this narrative review expands upon the limitations of AI and future direction.

Cite this article: Bone Joint Res 2023;12(7):447–454.


Bone & Joint 360
Vol. 12, Issue 3 | Pages 18 - 22
1 Jun 2023

The June 2023 Foot & Ankle Roundup360 looks at: Nail versus plate fixation for ankle fractures; Outcomes of first ray amputation in diabetic patients; Vascular calcification on plain radiographs of the ankle to diagnose diabetes mellitus; Elderly patients with ankle fracture: the case for early weight-bearing; Active treatment for Frieberg’s disease: does it work?; Survival of ankle arthroplasty; Complications following ankle arthroscopy.


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.


Aims

Olecranon fractures are usually caused by falling directly on to the olecranon or following a fall on to an outstretched arm. Displaced fractures of the olecranon with a stable ulnohumeral joint are commonly managed by open reduction and internal fixation. The current predominant method of management of simple displaced fractures with ulnohumeral stability (Mayo grade IIA) in the UK and internationally is a low-cost technique using tension band wiring. Suture or suture anchor techniques have been described with the aim of reducing the hardware related complications and reoperation. An all-suture technique has been developed to fix the fracture using strong synthetic sutures alone. The aim of this trial is to investigate the clinical and cost-effectiveness of tension suture repair versus traditional tension band wiring for the surgical fixation of Mayo grade IIA fractures of the olecranon.

Methods

SOFFT is a multicentre, pragmatic, two-arm parallel-group, non-inferiority, randomized controlled trial. Participants will be assigned 1:1 to receive either tension suture fixation or tension band wiring. 280 adult participants will be recruited. The primary outcome will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at four months post-randomization. Secondary outcome measures include DASH (at 12, 18, and 24 months), pain, Net Promotor Score (patient satisfaction), EuroQol five-dimension five-level score (EQ-5D-5L), radiological union, complications, elbow range of motion, and re-operations related to the injury or to remove metalwork. An economic evaluation will assess the cost-effectiveness of treatments.


Bone & Joint Open
Vol. 4, Issue 5 | Pages 338 - 356
10 May 2023
Belt M Robben B Smolders JMH Schreurs BW Hannink G Smulders K

Aims

To map literature on prognostic factors related to outcomes of revision total knee arthroplasty (rTKA), to identify extensively studied factors and to guide future research into what domains need further exploration.

Methods

We performed a systematic literature search in MEDLINE, Embase, and Web of Science. The search string included multiple synonyms of the following keywords: "revision TKA", "outcome" and "prognostic factor". We searched for studies assessing the association between at least one prognostic factor and at least one outcome measure after rTKA surgery. Data on sample size, study design, prognostic factors, outcomes, and the direction of the association was extracted and included in an evidence map.


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.