N/A
N=15
INDividualised EXercise for Kneecap Dislocations
Patella Dislocation · Patella Dislocation Recurrent
Bottom Line
View on ClinicalTrials.gov: NCT03798483 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Eligibility Rate — 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Individualised exercise (Other)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- City, University of London
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Eligibility Rate |
15 | — |
| PRIMARY Recruitment Rate |
15 | — |
| PRIMARY Attrition |
2 | — |
| PRIMARY Acceptability [Participant Satisfaction]: Questionnaire |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Adherence |
56 | — |
| PRIMARY Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] |
4; 5; 2 | — |
| SECONDARY Acceptability of Outcome Data Collection |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Number of Treatment Related Adverse Events Experienced by Participants |
1; 1; 13 | — |
| SECONDARY Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria |
100; 93.3; 66.7; 100 | — |
| SECONDARY Tegner Activity Scale Questionnaire |
6 | — |
| SECONDARY Lyhsolm Knee Scoring Scale Questionnaire |
90 | — |
| SECONDARY Quality of Life Using the EQ-5D-5L Questionnaire |
0.84; 90 | — |
| SECONDARY Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy] |
21 | — |
| SECONDARY Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants] |
3 | — |
| SECONDARY Assess Delivery of the Intervention [Duration of Intervention] |
50 | — |
| SECONDARY Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] |
13; 14; 15; 5; 5 | — |
| SECONDARY Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] |
90; 89; 91 | — |
| SECONDARY Assess Delivery of the Intervention [Initial Injury Management] |
12; 2; 1; 15; 7; 8 | — |
Summary
This study is a feasibility study. It will assess areas of uncertainty relating to the implementation of an individualised exercise programme for patients with a recent kneecap dislocation. This will help determine if a future larger study is feasible, and inform the design and conduct of future research that would aim to optimise outcomes after a kneecap dislocation.
Eligibility Criteria
Inclusion Criteria
- First time or recurrent lateral patella dislocation meeting the diagnostic criteria of 1) requiring reduction by paramedics or 2) diagnosed by a member of the trauma and orthopaedic team.
Exclusion Criteria
- Concurrent anterior cruciate ligament or posterior cruciate ligament injury confirmed by negative Lachman's and posterior drawer test or confirmed by Magnetic Resonance Imagery (MRI); medial collateral and lateral collateral ligament injury requiring application of a hinged knee brace or surgical repair; concomitant injury that would prohibit participation in the exercise intervention
- > 4 weeks from injury to presentation to acute care (ED or trauma services)
- Unable to give written informed consent
- Previous surgery on the affected knee
- Presence of fracture on plain radiograph including osteochondral fractures
- Medial patellar dislocation
- Considered inappropriate for referral to physiotherapy (by member of trauma and orthopaedic team assessing the patient)
- History of severe neuromuscular or congenital disorders
- Patients referred for orthopaedic opinion who are subsequently listed for surgery prior to completion of the study intervention
- Unable to understand written or spoken English
- Unable to attend physiotherapy sessions at the John Radcliffe trauma outpatient physiotherapy department
Data sourced from ClinicalTrials.gov (NCT03798483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.