Repair of Medial Patellofemoral Ligament Compared to Conservative Treatment for First Time Patella Dislocation

Stopped early · Not applicable

Conditions studied: Dislocated Patella, Torn Medial Patellofemoral Ligament

In brief

Background: The forces involved in a patella dislocation event can cause significant collateral damage involving the articular cartilage of the patella femoral joint. As a result, prevention of recurrent patella dislocation and the associated disability and morbidity has generated significant interest in the orthopedic community. Historically, nonoperative treatment for first time patella dislocation has been problematic due to high redislocation rates. Nonoperative protocols generally involve bracing and/or immobilization, followed by physical therapy (1). Surgical approaches to recurrent patella dislocation, both soft tissue and boney realignment operations, have also had mixed results, including low success rates, associated complications, and variable rates of return to functional activity (2,3,4). This study is intended to compare the outcomes of a relatively low-risk Medial Patellofemoral Ligament (MPFL) direct repair procedure to conservative treatment. Methods/Design: This study is designed as a two arm randomized prospective trial. Approximately fifty subjects will be randomly assigned to either a surgical or non-operative arm by means of a computer randomized allocation program. All subjects will have X-Ray Images and Magnetic Resonance Imaging (MRI) to determine the site of the MPFL damage, and to determine if any excluding conditions exist. Subjects randomized to the surgical group will have repair of the MPFL. Routine aftercare will consist of physical therapy in a clinic that has agreed to follow our protocol. Subjects randomized to the nonoperative group will receive 2 weeks of patellar immobilization, followed by patellar stabilization bracing with physical therapy for approximately 12 weeks. Physical therapy will progress through five phases with the goal of gait normalization, full range of motion and return to sport. Both arms will be given outcome questionnaires and physical activity assessments before treatment, and at one, three, six, twelve, and twenty four month intervals. Discussion: This prospective randomized trial will investigate the results of direct repair of the medial patellofemoral ligament and conservative treatment by applying subjective outcome measures (Kujala scores), and exam findings to determine MPFL functional restoration or redislocation. Subjects will be examined in the clinic setting at 10 days, one month, and six months post trauma. Any reported recurrent dislocation or subluxation event will be documented during recovery. All subjects will receive merchant x-ray views at 3 months with manual lateral translation of the patella.

Key facts

Study ID

NCT02185001

Run by

Orthopedic Specialty Institute

People needed

2

Starts

2014-10-01

Expected to finish

2016-03-01

Last updated by the study team

2017-03-09

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A first patellofemoral traumatic dislocation
• A need for reduction
• An absence of fractures on x-ray exam of the frontal and lateral knee and axial patella
• An absence of knee ligament lesions with surgical indications (with the exception of the MPFL)
• No previous knee surgery

You may not qualify if…

• A prior episode of patellofemoral dislocation
• Fractures on x-ray exam of the frontal and lateral knee and axial patella Prior surgery on the knee
• Tibial tuberosity-trochlear groove distance greater than 20mm
• Current pregnancy or plan to become pregnant during the study period.

Where it is running

• The Lyman Knee Clinic — Coeur d'Alene, Idaho, United States

Full record on ClinicalTrials.gov

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