Physiotherapy rehabilitation post patellar dislocation – is a full-scale trial feasible?

Not Applicable

• Conditions: Patients aged 14 years or older with an acute first-time or recurrent patellar dislocation; Musculoskeletal Diseases

• Registration Number: ISRCTN14235231
• Lead Sponsor: niversity of Oxford

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37430340/ (added 11/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-09
• Last Update Posted: 18 September 2023
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Aged =14 years
2. First-time or recurrent patellar dislocation confirmed if:
2.1. The patellar dislocation was reduced by a healthcare professional or
2.2. The patient reports a visible lateral patellar dislocation or sensation of the patella ‘popping out’ of joint followed by reduction and the assessing clinician diagnoses a lateral patellar dislocation
3. Willing and able to provide informed consent (patients aged =16 years), or for patients aged <16 years the parent is willing and able to provide informed consent for their child’s participation and the patient is able to provide assent should they wish to do so

Exclusion Criteria

1. >14 days from injury
2. Previous patellar stabilisation surgery on the affected knee
3. Requires acute surgical intervention (e.g., due to concurrent osteochondral fracture)
4. Contraindication(s) to participation in the study interventions
5. Patient is unable to adhere to study procedures
6. Previously randomised into the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study aims to determine if a full-scale randomised controlled trial comparing supervised versus self-managed rehabilitation for people after acute patellar dislocation is feasible by assessing the:1. Willingness to be randomised: proportion of eligible patients approached who are randomised over the recruitment period;2. Recruitment rate: number of participants recruited per month per site over the recruitment period;3. Intervention adherence: proportion of participants allocated to supervised rehabilitation” and self-managed rehabilitation” attending at least four physiotherapy sessions and one physiotherapy session, respectively;4. Retention: proportion of participants that return KOOS4 outcome data at 9 months; and5. Understanding participants’ experience of recovery, and the acceptability of the study interventions and follow-up methods to participants through semi-structured interviews conducted over the 9-month follow-up period