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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Repair of Medial Patellofemoral Ligament Compared to Conservative Treatment for First Time Patella Dislocation; A Randomized Prospective Trial

Brief Summary:

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 ques

Detailed Summary:

Background Historic treatment for first time patella dislocation has been largely conservative. Treatment options include nonoperative treatment and a large variety of operative options. Nonoperative treatment, usually consists of bracing and/or immobilization followed by physical therapy, has been problematic due to a relatively high reported redislocation rate(1). The forces involved in a patella dislocation event can damage 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.

Historic surgical approaches to recurrent patella dislocation have had mixed results. The isolated "lateral release", has been shown to have a very low success rate(2), while associated complications have been appreciated. Lateral release procedures are now more often performed in conjunction with other proximal or distal realignment procedures(3). More aggressive bone realignment procedures such as tibial tubercle transfers have the disadvantage of reported poor long term functional recoveries and low "return to sport" rates(4,5).

There has been increasing interest in ligament reconstruction for patella dislocation. The ligament of interest is the medial patella-femoral ligament (MPFL), which is essentially a thickened band of the medial capsule of the knee. The MPFL has been established as the primary constraint to patella dislocation. This ligament extends from a point just anterior to the attachment of the medial collateral ligament to the medial aspect of the patella, and is routinely disrupted with a patella dislocation event. The goals of reconstruction procedures are to replace and/or augment this band of tissue. While many reports of the results of MPFL rec
Sponsor: Orthopedic Specialty Institute

Current Primary Outcome: Patient Reported Change in Patellar Stability, Subluxation, or Recurrent Dislocation. [ Time Frame: 24 months, or as reported by subject ]

Subjects will be divided into 3 groups relating to patellar stability:

  1. Recurrence, indicating that the patient had a recurrent patellofemoral dislocation (total loss of congruence between the patella and trochlea) prior to 24 months.
  2. Unstable, indicating that the patient's knee presented with a positive apprehension test or showed signs of subluxation prior to 24 months, but without recurrent dislocation.
  3. Stable, indicating that the patient's knee did not show positive signs of episodes of subluxation at 24 months.


Original Primary Outcome: Same as current

Current Secondary Outcome: Subjective Outcome Measurement (Kujala Test) [ Time Frame: 1, 3, 6, 12, and 24 months ]

Patients will be asked to complete the Kujala knee pain questionnaire to record pain and function levels at various points in the study.


Original Secondary Outcome: Same as current

Information By: Orthopedic Specialty Institute

Dates:
Date Received: July 2, 2014
Date Started: October 2014
Date Completion:
Last Updated: March 7, 2017
Last Verified: March 2017