Patellar Instability: Physiotherapy or Surgery? (PIPS feasibility trial)

Not Applicable

Completed

• Conditions: Patellar instability; Musculoskeletal Diseases

• Registration Number: ISRCTN14950321
• Lead Sponsor: niversity Hospital of Coventry and Warwickshire NHS Trust

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/32642070/ (added 10/07/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-22
• Study Completion: 2019-01-15
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
orwich Patellar Instability Score (NPIS) at 12 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. The Norwich Patellar Instability Score (NPIS) at baseline, 3 and 6 months.<br> 2. The Banff Patella Instability Index (BPII) at baseline, 3, 6 and 12 months.<br> 3. The Kujala score at baseline, 3, 6 and 12 months<br> 4. The Oxford Knee Score – Activity and Participation Questionnaire (OKS-APQ) at baseline, 3, 6 and 12 months<br> 5. The EuroQol EQ5D (EQ5D-5L) at baseline, 6 weeks and 3, 6 and 12 months<br>