Physiotherapy or surgery for repeat kneecap dislocation: a randomised controlled trial

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2023
INTERVENTION: Randomisation: After consent has been obtained and baseline data have been collected, participants will be randomly allocated to one of the two treatment groups via a central computer‐based randomisation system provided by Warwick Clinical Trials Unit’s programming team. Randomisation will be in a 1:1 ratio using a minimisation procedure with a random factor of at least 70%, stratified by age group (<22/=22), site of recruitment, and presence of patella alta in the study knee. Trial interventions: A full summary of the PKT and surgical interventions will be available in the REPPORT manuals which will be prepared following surgical and non‐surgical consensus meetings. These manuals will be made available on the REPPORT trial webpage for ease of access for participants randomised to respective allocation groups. Personalised Knee Therapy (PKT) The PKT programme is an optimised package of tailored non‐operative care for patellar instability and will be based on the PKT programme developed for the PIPS feasibility trial. It will be developed further using data from the PIPS participant interviews, an evaluation of current relevant literature, our 2020 physiotherapy survey findings, and a consensus meeting of expert patients, PPI representatives, physiotherapists, health psychologists, and other stakeholders and practitioners with a specialist interest in knee rehabilitation. Surgery A REPPORT surgical manual will be produced based on published British Orthopaedic Association Standards for Trauma and Orthopaedics (BOAST) guidelines and the outcomes of a surgical consensus meeting comprising surgeons, patients, physiotherapists and other key stakeholders. The most widely recommended surgical procedure for patellar dislocation is medial patello‐femoral ligament (MPFL) recon CONDITION: Recurrent patellar dislocation ; Musculoskeletal Diseases PRIMARY OUTCOME: Knee Osteoarthritis Outcome Score (KOOS4) score at 18 months after randomisation SECONDARY OUTCOME: 1. KOOS4 at baseline, pre‐intervention, six, 12, and 24‐months.; 2. The five individual KOOS domains (symptoms, pain, activities of daily living, sports, quality of life) at baseline, preintervention, six, 12, 18, and 24‐months post randomisation.; 3. Norwich Patellar Instability (NPI) score at baseline, pre‐intervention, six, 12, 18, and 24‐months post‐randomisation.; 4. Health utility (EQ‐5D‐5L) at baseline, pre‐intervention, six, 12, 18, and 24‐months post‐randomisation.; 5. Work or education status (time off, change to status) at baseline, six, 12, 18, and 24‐months post randomisation.; 6. Satisfaction with social roles (PROMIS Satisfaction with Social Roles and Activities 4a Short Form) at baseline, six, 12, 18, and 24‐months post randomisation.; 7. Satisfaction with treatment at six, 12, 18, and 24‐months post‐randomisation using a 5‐point Likert scale.; 8. Patient global impression of change (PGIC) scale (single item) at six, 12, 18, and 24‐months post‐randomisation.; 9. Patellar dislocations at baseline, six, 12, 18, and 24‐months post‐randomisation.; 10. Adverse events including surgical complications at six, 12, 18, and 24‐months post‐randomisation.; 11. Further knee surgery (either arm) at six, 12, 18, and 24‐months post‐randomisation.; 12. Resources used by interventions and assessed at six, 12, 18, and 24‐months post‐randomisation.; INCLUSION CRITERIA: 1. Experienced at least two (self‐reported) lateral patellar dislocations affecting the same knee 2. Age 16 years or over
Epistemonikos ID: 0b76da8423c2c3f8823149f48c94146b264372dc
First added on: Feb 20, 2024