Recurrent patellar dislocation Musculoskeletal Diseases
Conditions
Interventions
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 randomisat
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Experienced at least two (self-reported) lateral patellar dislocations affecting the same knee 2. Age 16 years or over
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 18/06/2024: 1. Open growth plates on standard care imaging (typically but not restricted to MRI). Surgery in the skeletally immature requires different surgical techniques and is beyond the scope of this trial. 2. Presence of another knee condition which may cause instability (e.g., 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).* 6. Osteochondral/chondral injury requiring surgery, except removal of loose body. 7. Medial patellar dislocation or dislocations when the knee flexes (i.e., the patella is located in extension and dislocates every time the knee flexes). 8. Previous randomisation into the trial (i.e., the other knee). 9. Unable to have either physiotherapy or surgery. 10. Unable to adhere to trial protocols or completion of questionnaires (the need to offer translations will be kept under review by the trial team). * These are uncommon, <10% of the population, and challenging to treat. Previous participant exclusion criteria: 1. Open growth plates on standard care imaging (typically but not restricted to MRI). Surgery in the skeletally immature requires different surgical techniques and is beyond the scope of this trial 2. Presence of another knee condition which may cause instability (e.g., cruciate ligament instability, unstable meniscal tear) 3. Previous patellofemoral surgery, except simple arthroscopy with/without lateral release 4. Severe trochlea dysplasia requiring trochleoplasty* 5. Malalignment of femur or tibia requiring corrective osteotomy (not including tibial tubercle osteotomy)* 6. Osteochondral/chondral injury requiring surgery 7. Medial patellar dislocation 8. Previous randomisation into the trial (i.e., the other knee) 9. Unable to adhere to trial protocols or completion of questionnaires (the need to offer translations will be kept under review by the trial team) *These are uncommon, <10% of the population, and are challenging to treat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Osteoarthritis Outcome Score (KOOS4) score at 18 months after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed