Patellar instability Musculoskeletal Diseases Patellar instability
Conditions
Interventions
Participants will be randomly assigned by a computer to either a surgical arm or a non-operative arm consisting of a Personalised Knee Therapy.
Personalised Knee Therapy: Participants
Sponsors
University Hospital of Coventry and Warwickshire NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. Aged 16 or over and has closed growth plates on MRI scans (taken as part of standard clinical care) 3. Two or more patella dislocations, OR 1 dislocation with over 6 months of subjective instability leading up to the time of recruitment
Exclusion criteria
Exclusion criteria: 1. Patients who are unable to adhere to trial procedures or complete questionnaires 2. Previous entry in the present trial (i.e. for the other leg) 3. Patients with another knee condition that results in instability symptoms (ie cruciate ligament rupture, unstable meniscal tear which has not been treated) 4. Past knee surgery (except for simple arthroscopy with or without lateral release, or previous meniscal surgery) 5. Patients with medial dislocations of the patella. This is an exceptionally rare condition but would be treated differently in both arms if it were to occur. 6. Patients with developmental abnormalities of the lower limb requiring complex surgical intervention. This is because the conditions listed below require complex major orthopaedic procedures which may have a different risk-benefit balance to those in the planned study group, but are too rare to be included in the study and analysed separately. These include: 6.1. Severe trochlea dysplasia which (in the opinion of the treating surgeon) requires trochleoplasty 6.2. Rotational, coronal or sagittal mal-alignment of femur or tibia which in the opinion of the treating surgeon requires surgical correction (ie osteotomy) 7. Patients with an osteochondral injury or chondral injury who require surgical treatment. This is an uncommon but recognised complication of patellar dislocation and is treated surgically in the majority of cases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Norwich Patellar Instability Score (NPIS) at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The Norwich Patellar Instability Score (NPIS) at baseline, 3 and 6 months. 2. The Banff Patella Instability Index (BPII) at baseline, 3, 6 and 12 months. 3. The Kujala score at baseline, 3, 6 and 12 months 4. The Oxford Knee Score – Activity and Participation Questionnaire (OKS-APQ) at baseline, 3, 6 and 12 months 5. The EuroQol EQ5D (EQ5D-5L) at baseline, 6 weeks and 3, 6 and 12 months | — |
Countries
United Kingdom
Contacts
Public ContactElke Gemperle Mannion
Outcome results
None listed