Not Yet RecruitingNot Applicable

Conservative Versus Operative - First Time Patella Dislocations

United States200 participantsStarted 2026-09

Plain-language summary

There is no consensus regarding whether rehabilitation or surgical management is best for the management of a primary patellar dislocation. Consequently this prospective randomized controlled aims to compare the incidence of recurrent knee dislocations and patient reported outcomes of patients with primary patellar dislocations managed with surgery (medial patellofemoral ligament reconstruction) compared to non-operative management (a standardized rehabilitation protocol, control group).

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age 12 and older * patients seen by the Columbia University Shoulder Elbow and Sports Medicine Service * patients who experience a first-time patella dislocation Exclusion Criteria: * coexistent ligament injury or osteochondral fracture necessitating acute surgical intervention * previous knee surgery * knee instability prior to injury * inability or unwillingness to adhere to study participate * lost to follow up

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Kujala Questionnaire Score at 2 weeks

Timeframe: Baseline and 2 weeks

Change in Kujala Questionnaire Score at 6 weeks

Timeframe: Baseline and 6 weeks

Change in Kujala Questionnaire Score at 3 months

Timeframe: Baseline and 3 months

Change in Kujala Questionnaire Score at 6 months

Timeframe: Baseline and 6 months

Change in Kujala Questionnaire Score at 1 year

Timeframe: Baseline and 1 year

Change in Kujala Questionnaire Score at 2 years

Timeframe: Baseline and 2 years

Change in Kujala Questionnaire Score at 5 years

Timeframe: Baseline and 5 years

Trial details

NCT IDNCT05533671

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2032-09

Contact for this trial

David Trofa, MD

212 305 5974 dpt2103@cumc.columbia.edu

View on ClinicalTrials.gov More Patella Dislocation trials