Non-operative Treatment in First-time Patellar Dislocation

Study Overview
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Brief Summary
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Study to evaluate the conservative treatment of patients after their first episode of primary lateral patellar dislocation. Randomized controlled trial with 2 groups: standard treatment (2-weeks with brace) followed by physical therapy, compared with knee taping and physical therapy. 1-year follow-up. Measurements include physical exam, radiographs and MRI. Outcomes: recurrence, lateral patellar tilt, functional scores, apprehension, pain. Hypothesis: less recurrence in the knee taping group, as well as better functional scores.

Detailed Description
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Patients between 10-40 years old with first patellar dislocation are invited to participate in this conservative treatment study. Patients are excluded if they have bilateral acute patellar dislocation, previous surgeries in the affected knee, osteochondral fracture, open patellar dislocation. This is a randomized controlled trial with four groups of treatment: Standard treatment (2-weeks with a knee brace) and physical therapy Knee taping and physical therapy (1-week with knee brace) Sample size: 50 patients / knees Outcomes of interest: recurrence in patellar dislocation, functional scores (Banff, Norwich), return to sport, patellar tilt

Official Title
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Non-operative Treatment in First-time Patellar Dislocation: a Randomized Controlled Trial

Conditions
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Patellar Dislocation

Intervention / Treatment
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* Other: Standard care
* Other: Taping
* Device: Sham taping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients with first episode of acute lateral patellar dislocation during the last 7 days. Exclusion Criteria: * Patients with acute bilateral patellar dislocation. Patients with open patellar dislocation. Patients with previous knee surgery in the same knee.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Patients are randomized either to standard care or in the intervention group. Standard care patients are treated with knee brace (2 weeks) and physical therapy. In the intervention group: they receive knee taping with knee brace during 1-week.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>Standard care: knee brace for 2 weeks, physical therapy, sham taping (2-weeks) | Other: Standard care<br>* Bracing and physical therapy<br>Device: Sham taping<br>* Taping with no treatment disposition<br>|
| Experimental: Intervention group<br>Knee taping for 4-weeks, knee brace for 1 week, physical therapy | Other: Standard care<br>* Bracing and physical therapy<br>Other: Taping<br>* The patient is treated with tape in special configuration (McConell modified) for the patella + standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent patellar dislocation (percentage of patients) | Percentage of patients with additional patellar dislocation after the first episode | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Banff Patellofemoral Instability Instrument (BPII) | Patellofemoral instability specific score to assess function (disease-specific). The punctuation range is between 0-100 points. The best health scenario is 100% and the worst is 0. | 2 years | 
| Nich patellar instability (NPI) score | Patellofemoral instability specific score to assess function (disease-specific). The punctuation range is between 0-100%. The worst health deficit is 100% and the best is 0%. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brace, Patellar dislocation, Knee taping