Fundación Valle del Lili
Cali, Valle del Cauca Department, 760032, Colombia
Location status: Recruiting
Recruiting
NCT Number: NCT06086080
Non-operative Treatment in First-time Patellar Dislocation
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
10 year–40 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Standard care
OtherBracing and physical therapy
Taping
OtherThe patient is treated with tape in special configuration (McConell modified) for the patella + standard care
Sham Taping
DeviceTaping with no treatment disposition
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
-
Banff Patellofemoral Instability Instrument (BPII)
Time frame: 2 years
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.
-
Nich patellar instability (NPI) score
Time frame: 2 years
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%.
Other outcomes
-
Patellar tilt angle of patients after the first episode
Time frame: 1 month
Patellar tilt in magnetic resonance imaging (angle in degrees)
-
Patellar apprehension test
Time frame: 2 years
Patellar apprehension test during physical examination. The quadriceps should be relaxed to allow passive movements of the patella. The clinician will perform this technique by using their thumb of both hands, and pressing on the medial side of the patient's patella. The test is positive if it produces pain and apprehension.
-
Percentage of participants with patellar J sign
Time frame: 2 years
J sign during physical examination. The J-sign refers to the inverted 'J' track the patella takes from extension to early flexion. The J-sign is a clinical finding indicative of patellar maltracking.
-
Percentage of participants that return to sport activity
Time frame: 2 years
Percentage of the patients that were able to return to do their usual sport after the initial injury (patellar dislocation)
Study contacts
Contact information is provided by the study sponsor or research team.
Alejandro Gallego, MD
CONTACT
Juan P Martinez, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Fundacion Clinica Valle del Lili
Other
Collaborators
- International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
Registry information
Official study title
Non-operative Treatment in First-time Patellar Dislocation: a Randomized Controlled Trial
Important dates
- Study start
- 2023
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Oct 17, 2023
- Registry last updated
- Apr 3, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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