Conservative Versus Operative - First Time Patella Dislocations

Part of paid clinical trials in New York, New York.

Sponsor: Columbia University
Study ID: NCT05533671
Status: Not Yet Recruiting

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Conditions

Patella Dislocation

Eligibility Criteria

Sex: ALL
Age: 12 Years - N/A
Healthy Volunteers: Accepted

Interventions

medial patellofemoral reconstruction — PROCEDURE
Surgery to correct dislocated (knocked out of place) knee cap. This surgery anchors the kneecap back into the correct position and supports the kneecap.
Non-operative group — PROCEDURE
Physical therapy by following a specific regimen.

Study Details

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).

Key Dates

Start date: Sep 30, 2026
Status verified: Sep 2025
Primary completion: Sep 30, 2032
Completion: Sep 30, 2032

Study Design

Enrollment: 200 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Operative Group
This group will have surgical procedure called a medial patellofemoral reconstruction where the kneecap is anchored back into its correct position)
Active Comparator: Non-operative group
This group will have physical therapy for their knee dislocation by following a specific rehabilitation plan.

Primary Outcome Measure

Change in Kujala Questionnaire Score at 2 weeks [ Time Frame: Baseline and 2 weeks ]

Central Contacts

David Trofa, MD
212 305 5974
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Columbia University Irving Medical Center	New York	New York	10032	David P Trofa, MD [email protected] 212-305-5974 David P Trofa, MD (PRINCIPAL_INVESTIGATOR)

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Columbia University Irving Medical Center· New York, NY