Actively Recruiting
Non-operative Treatment in First-time Patellar Dislocation: a Randomized Controlled Trial
Led by Fundacion Clinica Valle del Lili · Updated on 2025-04-03
50
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
F
Fundacion Clinica Valle del Lili
Lead Sponsor
I
International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate different conservative treatments for patients who have experienced their first episode of primary lateral patellar dislocation. The study compares two approaches: a standard treatment involving two weeks of knee bracing followed by physical therapy, and a treatment using knee taping combined with physical therapy. Researchers are investigating outcomes such as recurrence of dislocation, knee tilt, functional scores, pain, and apprehension over a one-year follow-up period. Participants are randomly assigned to one of two groups. The standard care group receives a knee brace for two weeks, physical therapy, and sham taping for two weeks. The intervention group receives knee taping for four weeks, a knee brace for one week, and physical therapy. The study includes measurements like physical exams, radiographs, and MRI scans to monitor progress and outcomes. During the study, participants undergo regular assessments including physical examinations and imaging studies. Functional scores such as the Banff Patellofemoral Instability Instrument and Norwich scores are used to evaluate knee function. The main outcome measured is the percentage of patients who experience recurrent patellar dislocation within two years. Safety and effectiveness are monitored throughout, with a total participation period that includes a one-year follow-up and ongoing outcome evaluation.
CONDITIONS
Brief Title
Non-operative Treatment in First-time Patellar Dislocation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with first episode of acute lateral patellar dislocation during the last 7 days
- Age between 10 and 40 years
You will not qualify if you...
- Patients with acute bilateral patellar dislocation
- Patients with open patellar dislocation
- Patients with previous knee surgery in the same knee affected by dislocation
- Age younger than 10 or older than 40 years (implied from study age limits)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 to 4 weeks
Participants receive non-operative treatment for first-time patellar dislocation, including knee bracing, physical therapy, and taping depending on their assigned group.
1 to 2 visits depending on assigned treatment group
Duration - 2 years
Participants are monitored for recurrence of patellar dislocation and functional outcomes over 2 years.
Periodic visits for outcome assessments
Trial Site Locations
Total: 1 location
1
Fundación Valle del Lili
Cali, Valle del Cauca Department, Colombia, 760032
Actively Recruiting
Research Team
J
Juan P Martinez, MD
A
Alejandro Gallego, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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