A Feasibility Study into Patellar Instability: Physiotherapy or Surgery (the PIPS feasibility study)

niversity Hospital of Coventry and Warwickshire NHS Trust0 sites19 target enrollmentDecember 22, 2016

Overview

Registry

who.int

Start Date

December 22, 2016

End Date

January 15, 2019

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity Hospital of Coventry and Warwickshire NHS Trust

•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

•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