To determine the feasibility of conducting a full-scale randomised controlled trial comparing supervised versus self-managed rehabilitation for people with an acute patellar dislocation.
Two-group parallel external pilot RCT and embedded qualitative study. Participants were aged ≥14 years with an acute (21 days of injury) patellar dislocation from five English hospitals. Participants were randomised by a web-based service 1:1 to supervised (4-6 physiotherapy sessions of tailored advice and exercise over a maximum of six months) or self-managed rehabilitation (one physiotherapy session of advice, exercise and provision of self-management materials). Primary quantitative feasibility objectives were 1.) willingness of eligible patients who were approached to be randomised 2.) number of participants recruited per site per month, 3.) intervention adherence: proportion of supervised rehabilitation participants that attended at least four physiotherapy sessions and self-managed rehabilitation participants that attended at least one session, and 4.) retention (complete 9-month follow-up questionnaires, the planned full-scale RCT primary outcome timepoint). Follow-up questionnaires were sent electronically 3, 6, and 9 months after randomisation. We also planned to interview ≤20 participants to understand their experience of recovery, and intervention and follow-up method acceptability.
Trial registration: ISRCTN14235231
Pilot trial recruitment began in January 2023 and closed in August 2023 when the recruitment target of 50 participants was recruited. The willingness to be randomised was 56.8% (50/88 participants, 95% confidence interval (CI) 46.4% to 66.7%). The average number of participants recruited per site per month was 1.38 (95% CI 0.6 to 1.8). Intervention adherence was 72% (95% CI 58% to 83%). Retention was 62% (95% CI 48.2% to 74.1%). There were no serious adverse events. Three participants, all allocated to self-managed rehabilitation, experienced a new ipsilateral patellar dislocation. Semi-structured interviews with nine pilot RCT participants showed that the experience of patellar dislocation recovery was conveyed through the themes ‘coming to terms with the initial injury’ and ‘regaining my former self’. Qualitative findings also showed that the pilot RCT follow-up methods were acceptable to patients, indicating that the low pilot RCT retention was not due to the follow-up methods used.
A full-scale RCT comparing supervised versus self-managed rehabilitation is feasible, but modifications are required, particularly to improve retention. Refinements should be informed by wider consultations with relevant stakeholders, such as patients and clinicians. This will increase the chances the full-scale RCT is conducted successfully and the findings will be implemented in practice.
A full-scale RCT comparing supervised versus self-managed rehabilitation is feasible. This future RCT's results would provide the high-quality evidence needed to inform rehabilitation provision for these patients.
patellar dislocation
pilot study
