Recurrent patellar dislocation: personalised therapy or operative treatment? The REPPORT randomised trial protocol

Abstract

Introduction

Recurrent patellar dislocation is a debilitating musculoskeletal condition, affecting mainly adolescents and adults under the age of 30. It can persist for many decades, causing pain and cartilage and soft-tissue damage, potentially leading to osteoarthritis. Recurrent patellar dislocation can be managed with physiotherapy or surgery. However, it is not known which treatment is most effective.

Methods and analysis

Recurrent Patellar Dislocation: Personalised Therapy or Operative Treatment (REPPORT) is a pragmatic, multicentre, two-arm, superiority, randomised controlled trial. It will compare the clinical and cost-effectiveness of an initial management strategy of personalised, phased and progressive rehabilitation, termed personalised knee therapy versus surgery for recurrent patellar dislocation.

The trial’s target sample size is 276 participants who will be recruited from approximately 20 sites across the UK. Participants will be randomly allocated to the two treatment groups via a central computer-based minimisation system. Treatment allocation will be in a 1:1 ratio, stratified by age, presence of patella alta and recruitment site.

The primary outcome is participant-reported function using the Knee injury and Osteoarthritis Outcome 4-domain score at 18 months post randomisation. Health economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data including patellar instability, health utility, work/education status, satisfaction with social roles and treatment, health resource use and adverse events will be collected at 6, 12, 18 and 24 months. Analysis will be on an intention-to-treat basis and reported in-line with the Consolidated Standards of Reporting Trials statement.

Ethics and dissemination

The trial was approved by the East Midlands—Nottingham 2 Research Ethics Committee on 30 March 2023.

Results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries, and using the REPPORT website and social media channels.

Trial registration number

ISRCTN17972668.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This will be the largest randomised controlled trial (RCT) of the management of recurrent patellar dislocation.

• This is a multicentre RCT recruiting participants from across England, Wales, Scotland and Northern Ireland which promotes National Health Service generalisability.

• This is a non-blinded trial due to impracticability of blinding for rehabilitation.

• There is a potential for discrepancy in time to intervention between the treatment arms due to differential waiting list durations.

Introduction

Recurrent patellar dislocation is a profoundly debilitating condition. It affects mainly adolescents and adults under 30 years. Recurrent dislocations can persist for many decades and cause pain, and cartilage and soft-tissue damage as well as long-term consequences for people’s health and well-being.¹,⁵ It is common for those affected to develop osteoarthritis in the affected joint, leading to long-term disability and greater need for health services.⁴,⁶

First-time (primary) patellar dislocation affects up to 43 per 100 000 people with an estimated incidence of 147 per 100 000 among young females.⁷,⁹ It is usually treated conservatively (non-surgical). There is increased risk of having a second (recurrent) dislocation within the first 5 years of a primary dislocation, occurring in approximately 40% of cases.^{3 10 11} Recurrent dislocations result in ongoing restrictions and patient outcomes are poor.¹⁰,¹³ Between dislocations, many of those affected report a feeling of instability or that their patella is about to dislocate. These problems can lead to activity modification, cause severe disruption to education, work and social or physical pursuits and have a major impact on quality of life as individuals try to avoid dislocations or instability symptoms.³¹⁴,¹⁷

Recurrent patellar dislocation can be managed with physiotherapy or surgery. There is uncertainty as to which strategy is best.¹⁸,²⁰ Currently, treatment decisions are based on the treating clinician’s opinion.^{11 19 21 22} Some feel that without surgery, dislocations and restriction will persist or worsen as structures around the knee could be damaged. Others believe that physiotherapy is effective and avoids the discomfort, risks, recovery period and cost of surgery.^{11 19}

As well as impacting patients, recurrent patellar dislocation is also a burden on health services. In 2020, unpublished data from a collaborative study for the British Association for Surgery of the Knee reported 3639 cases from 45 National Health Service (NHS) Trusts over a 5-year period. Extrapolated to the whole NHS, the data suggest around 2000 surgical cases are performed annually, costing approximately £5M.

There is no evidence from randomised controlled trials (RCTs) to determine the best practice in managing recurrent patellar dislocation. In 2019, we completed a mixed-method feasibility RCT (Patellar instability: Physiotherapy vs Surgery (PIPS)) across three NHS sites comparing a bespoke personalised knee therapy (PKT) intervention versus surgery with postoperative rehabilitation for recurrent patellar dislocation.²³ The aim was to determine the feasibility of conducting an RCT in the recurrent patellar dislocation population, including recruitment strategies, retention of participants, clinician and participant equipoise, and data collection methods. The feasibility RCT highlighted numerous challenges requiring a series of changes to ensure adequate recruitment and follow-up. When implemented, the revised trial design was found to be a feasible model to deliver a full trial.²³

To determine the best practice for people presenting with recurrent patellar dislocation, a definitive RCT is needed. Here, we summarise the protocol for Recurrent Patellar Dislocation: Personalised Therapy or Operative Treatment (REPPORT); an RCT comparing the decision to offer physiotherapy or surgery as a primary treatment strategy for recurrent patellar dislocation.

Aims and objectives

The aim of the REPPORT trial is to determine whether an initial management strategy of PKT or surgical care is the most clinically effective and cost-effective approach for people with recurrent patellar dislocation (two or more dislocations in the same knee).

Methods and analysis

Trial design

REPPORT is a pragmatic, multicentre, two-arm, superiority, RCT comparing the clinical and cost-effectiveness of PKT (non-surgical care) versus surgery. The trial is powered to test superiority but with equipoise between intervention arms. REPPORT is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (HTA project: NIHR134398). The trial opened to recruitment in August 2023 and expected end date is December 2027.

This protocol paper was written following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.²⁴ Figure 1 shows the participant flow diagram. The participant consent form is presented in online supplemental file 1. A summary of core trial information is presented in the WHO trial registration data set (online supplemental file 2).²⁵

Figure 1. Recurrent Patellar Dislocation: Personalised Therapy or Operative Treatment (REPPORT) participant flow diagram. KOOS4, Knee injury and Osteoarthritis Outcome 4-domain score; PKT, personalised knee therapy.

Patient and public involvement

Patient and public involvement (PPI) has been critical in designing and developing the trial and will continue to be important in its delivery and dissemination of results.

We have engaged with a PPI group who have had treatment (surgery and physiotherapy) for patellar dislocation to learn more about their experiences but also to get their input into our trial design and development of patient facing materials. Two of these PPI representatives are coapplicants on the trial’s research team and this manuscript. Our PPI coapplicants are integral to the Trial Management Group (TMG), attending trial management meetings, contributing the patient perspective to trial processes, procedures and documentation. They will be key to our dissemination plan. Two further PPI representatives sit on the Trial Steering Committee (TSC).

Objectives

Primary objectives

• To compare the clinical effectiveness of PKT versus surgery, based on participant-reported function, 18 months post randomisation, using the Knee injury and Osteoarthritis Outcome 4-domain score (KOOS4).

• To compare the cost-effectiveness of PKT versus surgery from an NHS and personal social service (PSS) perspective.

Secondary objectives

• To quantify and draw inferences on function, pain, instability, number of dislocations, health utility, work or education status, satisfaction with social roles, resource use, further surgery and adverse events (AEs) at 6, 12, 18 and 24 months.

• To evaluate process measures to compare days from randomisation to treatment initiation, and PKT and postoperative rehabilitation attendance and adherence.

Outcome measures

Outcome measures were selected in collaboration with our PPI representatives and our experienced clinical team. In-line with SPIRIT guidance,²⁴ details of the schedule of enrolment, interventions and assessment are presented in online supplemental file 3.

Primary outcome

The primary clinical effectiveness outcome is participant-reported knee function using the four domain KOOS4 score 18 months post randomisation. This is a 25-item knee-specific instrument (0–100; 100 best score) which sums four of the five domains of the full KOOS score (the domains for symptoms, pain, function/sports and quality of life, but not activities of daily living).²⁶ It has been widely used in previous trials in knee surgery, including young adult non-arthritic populations such as this one, and is well-accepted by clinicians.²⁷,³¹

A prospectively planned economic evaluation will be conducted from an NHS and PSS perspective, according to the recommendations of the National Institute for Health and Care Excellence (NICE) reference case.³² Bespoke resource utilisation questions about health service and social service contacts made in connection with the participant’s treatments, as well as time lost from work (paid/unpaid), will be incorporated into participant questionnaires.

Secondary outcomes

All collected at baseline, 6, 12, 18 and 24 months. Given there may be a differential wait for the intervention between arms, we will also collect KOOS4 and EQ-5D-5L from all participants within 4 weeks before the start of their allocated intervention.

• KOOS4.

• The five individual KOOS domains (symptoms, pain, activities of daily living, sports, quality of life).^{26 33}

• Norwich Patellar Instability score.¹⁵ A validated tool used to assess perceived patellar instability.

• Health utility (EQ-5D-5L and EQ-VAS).^{34 35} The EQ-5D-5L is a validated measure of health status consisting of five dimensions each with a five-level answer possibility.

• Work or education status (time off, change to status).

• Satisfaction with social roles (Patient-Reported Outcomes Measurement Information System (PROMIS) scale).³⁶

• Satisfaction with treatment using a five-point Likert scale.³⁷

• Patient Global Impression of Change scale (single item).³⁸ This is a simple 7-point scale assessing perception of improvement.

• Self-reported patellar dislocation events.

• Further knee surgery and/or physiotherapy (either arm).

• Health resource use.

Safety outcomes

• AEs and serious adverse events (SAEs) related to the surgical procedure including the surgery, anaesthetic, postoperative care and rehabilitation, any component of the PKT programme or any knee treatment in the reporting period will be collected according to relevant Warwick Clinical Trials Unit (WCTU) Standard Operating Procedures (SOPs) from the point of randomisation until 24 months.

Process and fidelity measures

• Days from randomisation to treatment initiation.

• PKT and surgical case report forms (CRFs) plus postoperative physiotherapy CRFs to assess intervention fidelity including information on:

  • Number of PKT sessions offered and attended.

  • Composition of PKT.

  • Details of surgery including surgical procedure, surgical findings, theatre time, tourniquet time and any other procedures.

  • Number of postoperative physiotherapy sessions offered and attended.

  • Composition of postoperative physiotherapy.

Eligibility criteria

Inclusion criteria

1. Experienced at least two (self-reported) lateral patellar dislocations affecting the same knee.

2. Age 16 years or over at trial entry.

Exclusion criteria

1. Open growth plates on standard care imaging (typically but not restricted to MRI).

2. Presence of another knee condition which may cause instability (eg, cruciate ligament instability, unstable meniscal tear).

3. Previous patellofemoral surgery, except simple arthroscopy with/without lateral release.

4. Severe trochlea dysplasia which, in the opinion of the treating clinician, requires trochleoplasty.

5. Malalignment of femur or tibia requiring corrective osteotomy (not including tibial tubercle osteotomy (TTO)).

6. Osteochondral/chondral injury requiring surgery, except removal of loose body.

7. Medial patellar dislocation or dislocations when the knee flexes (ie, the patella is located in extension and dislocates every time the knee flexes).

8. Previous randomisation into the trial (ie, the other knee).

9. Unable to have either physiotherapy or surgery.

10. Unable to adhere to trial protocols or complete questionnaires.

Extra detail was added to the exclusion criteria after commencement of the trial. Unable to have either physiotherapy or surgery was added and approved by East Midlands—Nottingham 2 Research Ethics Committee (REC) on 22 August 2023 and additional detail about removal of loose bodies⁶ and dislocations when the knee flexes⁷ were approved on 12 January 2024.

Participant identification, screening and withdrawals

Participants will be identified by clinical teams predominantly from NHS orthopaedic departments and acute musculoskeletal services (such as injury review clinics). Depending on individual site contexts, potential participants could also be recruited from NHS emergency departments or physiotherapy services.

Eligibility will be assessed by routine clinical evaluation, with no requirement for any trial-specific investigation by an appropriately delegated clinician. Screening data will be entered directly on to the trial database.

Potential participants who are eligible will be given verbal and written information (either in person, by post or email) about the trial and invited to discuss it further with a member of the research team. They will be given adequate time to consider participation. A delegated member of each local research team will obtain informed consent from each participant, collecting either written consent or witnessed remote verbal consent and they will also collect baseline data.

Information sheets, invitation letters and other approved patient-facing materials including follow-up questionnaires may be posted, emailed, physically provided or shared via online links to participants.

Randomisation

Participants will be randomly allocated to the two treatment groups via a central computer-based minimisation system provided by WCTU’s programming team, independent of the study team. This will be performed after consent has been obtained and baseline data have been collected.

Treatment allocation will be in a 1:1 ratio using a minimisation procedure with a random factor of 70%, stratified by age group (<22/≥22 years), site of recruitment and presence of patella alta in the study knee (defined as yes/no by the presence of either a Biedert patella-trochlea overlap ratio <0.25 on cross-sectional imaging or Caton-Deschamps >1.2 on lateral radiograph/other routine clinical imaging).³⁹,⁴¹

Randomisation will be performed by any delegated member of the local clinical or research team, using the online system. Randomised participants can choose to discontinue their treatment and/or withdraw from follow-up at any time, without prejudice. This will have no effect on their current or future care. All withdrawals will be monitored by the TMG and oversight committees.

Trial treatment(s)/interventions

Group 1: PKT

The PKT programme is based on the intervention developed for the PIPS feasibility RCT.²³ It was refined following a consensus meeting held in March 2023, whereby 12 experts in patellofemoral disorders and management convened to finalise a comprehensive evidence-based, phased, progressive, PKT programme for the trial, ensuring it is deliverable across all NHS sites. A template for intervention description and replication checklist⁴² for the REPPORT PKT intervention is presented as online supplemental file 4.

PKT aim

To work with the participant to reduce pain and swelling, optimise knee range of motion, improve lower limb strength, stability and function and improve confidence by addressing fear avoidance and maladaptive health beliefs, with the overarching aim of functional restoration to activities meaningful to the participant, that is, work, college/education, sports and recreational pursuits.

Delivered by

Physiotherapists trained in the principles of the REPPORT PKT programme. Training includes a background to the problem of recurrent patellar dislocation, the rationale for the trial, an overview of the PKT framework and phased programme, and trial documentation. Trained physiotherapists receive a REPPORT PKT manual containing a detailed account of trial and intervention procedures.

Mode of delivery

The intervention will be personalised to the participant, allowing for flexibility for PKT to be delivered face-to-face (either individually or in groups) in acute hospital or community physiotherapy departments, through virtual consultations, or a hybrid of the two.

Duration

Minimum of 3 months from first assessment incorporating up to six sessions. However, participants can be discharged earlier if they have achieved their treatment goals or extend their treatment as clinically required, reflecting normal clinical practice. Attendance to no physiotherapy visits will be considered non-compliance with PKT. Attendance at one to three sessions of PKT and goals not met will be considered as partial compliance. Attendance at four or more sessions or less than four session with goals met will be considered full compliance. This detail will be recorded on the PKT CRF.

Treatment starting point from randomisation

When an appointment with a physiotherapist is available in accordance with normal NHS service waiting times.

Timing of consultations

The interval between consultations will be personalised to the needs of the participant, based on their progress, presentation and treatment goals.

Assessment

Initial assessment will include participant’s history (subjective assessment) and physical examination (objective assessment). This will follow a routine musculoskeletal physiotherapy assessment and will be used to determine which phase of treatment the participant commences the PKT programme. The PKT programme has three phases (A, B and C). These are framed on functional progression, based on objective criteria:

• Progression from phases A to B requires the participant to have good range of knee motion and quadriceps strength with minimum pain and swelling.

• Progression from phases B to C (return to sport and higher level function) requires the participant to have good proximal lower limb muscle control with rotational stability on multidirectional activities.

• People who experience instability symptoms or recurrent dislocation can return to an earlier phase.

Treatments

Based on individualised problems and goal setting, the intervention is aimed to specifically manage the participant’s presenting problems which are likely to include but not limited to knee pain and swelling, reduced knee mobility, reduced lower limb muscle length and strength, abnormal gait pattern, increased knee instability and fear avoidance or maladaptive health beliefs. This personalised approach aims to optimise rehabilitation outcomes. Treatments that could be offered include one-to-one or group-based exercise programmes plus adjuncts including thermal treatments, orthotics, taping and biofeedback as well as advice and education and behaviour modification techniques. Each participant will be given a manual including their specific treatment goals, information about their PKT programme with details of specific individualised exercises and an exercise planner to encourage self-monitoring and adherence.

Group 2: surgery with postoperative rehabilitation

Surgery will be performed according to published British Orthopaedic Association Standards for Trauma and Orthopaedics guidelines.⁴³ Based on established guidance and current reviews, the most widely recommended surgical treatment is medial patellofemoral ligament reconstruction,⁴⁴ whereby the gracilis or semitendinosus tendon is harvested and attached between the patella and the femur, using a screw in the femur. This typically involves three incisions of around 3 cm each. Complications are infrequent (approximately 3%–5%) and redislocation rates are between 2% and 5%.⁴⁵,⁴⁸

Participants with patella alta (approximately 30%–50% of the recurrent dislocation population)⁴⁹ or where otherwise indicated may also undergo a simultaneous TTO, where the bony attachment of the patella tendon is cut and moved by approximately 1 cm. This involves an incision of about 8 cm and would typically be performed simultaneously with an MPFL reconstruction.

All care, including the choice of anaesthetic, the surgical procedure and postoperative analgesia, will be in accordance with usual procedures and care at participating sites.

Postoperative rehabilitation for the surgery group will be a programme based on the minimum standard of care consistent with normal NHS practice. The programme will start within the first 3 weeks after surgery and comprise lower-limb exercise-based rehabilitation from a physiotherapist with the aim of maximising postoperative recovery and functional restoration. Where possible, at each location, the physiotherapists delivering PKT will not deliver postoperative rehabilitation (and vice versa). Delivery of PKT and postoperative physiotherapy will be monitored via PKT and postoperative CRFs. A REPPORT PKT programme will not be used prior to surgery, but routine or current preoperative physiotherapy is permitted.

Participants randomised to surgery will be considered non-compliant if the operation does not occur. They will be partially compliant if they have the operation but no postoperative physiotherapy sessions and fully compliant if they have their surgery and one or more postoperative physiotherapy sessions.

End of trial

The trial will end when analysis of 24-month follow-up data is completed. This will be extended if funding is received for 5-year or 10-year follow-up (we will obtain participant consent for long-term follow-up at baseline).

The trial will only be stopped early if mandated by the REC or sponsor; following recommendations from the Data Monitoring Committee (DMC) to the TSC, or the TSC independently; or if funding for the trial ceases.

Safety reporting, AEs and SAEs

All AEs and SAEs will be defined using widely accepted standard criteria. For this trial, AEs and SAEs will be collected from the point of randomisation up to 24 months. To avoid unnecessary reporting, some events which occur during the interventions will be considered normal aspects of therapy, anaesthetic, surgery and postoperative recovery, unless in the opinion of the clinical team, they are untoward, excessive or outside of what might normally be expected; these will not need reporting. We will only collect AEs and SAEs related to the participants’ knee, treatment they receive in the trial (or any treatment for the study knee) or trial processes.

SAEs will be reported to WCTU within 24 hours of research staff becoming aware of the event. These will be followed up until they are resolved, or until the end of the trial, and an outcome has been agreed.

Statistical analysis

Power and sample size

We performed a scoping review of papers reporting KOOS4 in patellar dislocation and used the method outlined by Chen et al⁵⁰ to calculate an estimate of the SD. This identified 10 studies (non-surgical and surgical treatment) from which the 80th centile of the SD was determined to give a conservative estimate of 21. Based on our feasibility RCT and data from other orthopaedic studies within our unit, we assumed that follow-up data are correlated with those collected at baseline (within person similarity). We conservatively estimate the correlation coefficient (ρ) as 0.5 for the KOOS4 at 18-month follow-up. By explicitly including this adjustment in the sample size calculation, we reduce the effective SD from 21 to 18.2.

We anticipate that there will be some treatment switching between allocation groups in this pragmatic trial. Hence, the choice of target difference should reflect any potential dilution of the observed treatment effect in the primary intention-to-treat (ITT) analysis. Therefore, reducing the between-group target difference in KOOS4 score from 10 to 8 points (an effect size of 0.44) represents an important worthwhile difference for this design and population.

For a two-group parallel arm design, 90% power and 5% significance, we require data on 110 participants in each group, allowing for an anticipated 20% loss to follow-up results in a target sample size of 276 participants. In this trial, each site will contribute small numbers and inflation for clustering is not necessary.

Statistical analysis plan

A comprehensive statistical analysis plan will be agreed with the DMC prior to any formal analysis taking place. All analyses will be reported inline with Consolidated Standards of Reporting Trials guidelines and WCTU SOPs.^{51 52} Descriptive statistics will be constructed for baseline data to check for any characteristic differences between allocation groups.

The primary outcome will be analysed on an ITT basis and in-line with the trial’s superiority design; although no direction is stated, either is feasible and powered for. A generalised linear model will be used to assess differences in the KOOS4 score between treatment groups at 18 months post randomisation. At a minimum, the model will include terms for allocation, age, sex, recruitment site, presence of patella alta and baseline KOOS4 score. If other important baseline variables are identified, they may be fitted as appropriate. Random effects models will be used, with a random effect for recruitment site. Secondary outcomes will be analysed using a similar approach as appropriate to data and distribution. Categorical outcomes will be analysed with similar structure of models but with proportional logistic regression models.

Prespecified subgroup analyses will be undertaken to explore whether the intervention effect differs between: age group (<22 or ≥22 years) and presence of patella alta (yes/no). The subgroup analyses will follow the methods described for the primary analysis, with additional interaction terms incorporated into the mixed-effect regression model to assess the level of support for these hypotheses. The trial is not powered to formally test these hypotheses, so they will be reported as exploratory analyses only.

Primary inferences will be drawn from the models outlined under the ITT principle for the trial intervention of the initial treatment strategy. However, treatment switching is an important consideration in this trial and other analysis populations will be used for exploratory analysis. An ‘as-treated’ population, defined by the actual treatment received (ie, those who underwent surgery and those who adhered to PKT), will be conducted. Per-protocol analysis, restricted only to participants who adhere to protocolised treatment, will also be conducted to assess impact of protocol non-adherence. The results of any exploratory analysis in non-ITT populations will be interpreted with caution because bias from confounding can be introduced by moving participants from their randomised group.⁵³ Missing data will be scrutinised, and if deemed necessary, accounted for using multiple imputation methods.

Database

All data will be entered and stored in a bespoke database management system developed by the programming team at WCTU. This is supported by a detailed Data Management Plan produced in accordance with WCTU SOPs to ensure high-quality data collection throughout the duration of the trial.

Health economic evaluation

A prospectively planned economic evaluation will be conducted from an NHS and PSS perspective. Health service contacts, made in connection with their interventions and time lost from education and/or work (paid/unpaid) at 6, 12, 18 and 24 months, will be recorded as part of the resource utilisation questions. Intervention and sequelae healthcare resource use will be costed using most recently available UK published national reference costs, reflated to a common year.^{54 55}

Health-related quality of life will be assessed using the EQ-5D-5L.³⁴ These scores will be converted to health status scores using the UK value set recommended by NICE guidance at the time of analysis.⁵⁶ The area-under-the-curve health status scores will be calculated using the trapezoidal rule, providing patient-level quality-of-life years (QALYs) estimates.

If missingness of patient-level costs or QALYs ≤5%, the primary analysis will use complete case data.⁵⁷ If missingness exceeds 5%, mechanisms of missingness of data will be explored and multiple imputation methods will be applied to impute missing data. Complete case data or imputation sets will be used in bivariate analyses of costs and QALYs to generate within trial incremental cost per QALY estimates and CIs.⁵⁸,⁶¹ Findings will be analysed and visualised as cost-effectiveness acceptability curves, net monetary benefit and value of information analysis. Prespecified sensitivity analysis will be used to explore the robustness and generalisability of findings.

The within-trial analysis will serve as the primary analysis under several conditions reflected in the pattern of incremental costs and QALYs over the 24-month follow-up: if these converge (no longer-term difference between interventions) or if they diverge such that either PKT or surgery are clearly dominant (with further extrapolation uninformative). If further modelling is likely to be informative, then the modelled finding will form the primary analysis. We will develop a decision analytic model, using our expertise in economic modelling in knee surgery.⁶²,⁶⁴ The probabilistic model is likely take the form of a Markov model, capturing subsequent surgery including primary and revision knee replacement over the life course, with parameters drawn from published sources.^{65 66} Reporting will follow the Consolidated Health Economic Evaluation Reporting Standards statement.⁶⁷

Ethics and dissemination

The trial was approved by the East Midlands—Nottingham 2 REC on 30 March 2023 (23/EM/0075). The REPPORT trial will adhere to the Declaration of Helsinki and Good Clinical Practice principles, complying with all relevant WCTU SOPs. Participants will provide informed consent before agreeing to take part. An independent DMC and TSC will provide oversight from set-up to the end of the trial. Both committees will comprise independent members as per the NIHR and WCTU SOPs requirements. Members will sign separate committee charters. Protocol amendments will be disseminated to sites by the trial coordinating team.

Data Sharing

De-identified data underlying the trial results will be available for non-commercial use, up to one year after publication of the trial findings, or from metadata stored in a university repository up to 10 years without investigator support. To access trial data, third parties must complete a data-sharing agreement with the sponsor, have an ethically approved protocol in place for use of the data, and agree the approved protocol with the REPPORT TMG and WCTU Data Sharing Committee. Data may be used for commercial purposes, according to the conditions above, but will need specific agreements in place prior to access being agreed, and may include a license fee. Analyses may include individual patient data meta-analyses or other purposes as agreed with the REPPORT TMG. Available data will include (but is not exclusive to) de-identified individual participant data, the trial protocol, SAP, master copy of the informed consent sheets and scripts or files used to conduct trial analyses.

Trial registration and study timelines

The trial is registered with the ISRCTN register (ISRCTN17972668). The current version of the protocol is V4.0, approved on 15th January 2024. The planned timeline of the trial is from January 2023 to December 2027.

Dissemination and publication

Results will be shared with trial collaborators and the main results paper will be drafted by the trial team and agreed by the TSC prior to submission to a major peer-reviewed journal. Summary briefing papers, press releases and social media posts will be prepared for the wider community with specific input from our PPI team. These outputs will allow for the results to be disseminated across the orthopaedic and rehabilitation communities, the wider medical community, policy makers and patients and society at large in the UK, and globally. Dissemination to trial participants will follow current Health Research Authority (HRA) guidelines, with summaries available on the REPPORT website and social media channels.