Non-operative Treatment in First-time Patellar Dislocation: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Fundacion Clinica Valle del Lili
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Recurrent patellar dislocation (percentage of patients)
Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The investigator and outcomes assessor will not have access to the type of treatment a patient received.
Eligibility Criteria
- Ages
- 10 Years to 40 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Recurrent patellar dislocation (percentage of patients)
Time Frame: 2 years
Percentage of patients with additional patellar dislocation after the first episode
Secondary Outcomes
- Nich patellar instability (NPI) score(2 years)
- Banff Patellofemoral Instability Instrument (BPII)(2 years)