A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction

Study Overview
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Brief Summary
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The operative management of chronic patellar instability has been controversial. Medial patellofemoral ligament reconstruction has gained success recently and might be superior to other soft-tissue procedures. The objective of this prospective study was to compare the clinical outcome after medial patellofemoral ligament reconstruction compared with medial reefing for chronic patellar instability.

Detailed Description
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Many of the previous studies on medial patellofemoral ligament (MPFL) reconstruction for patellar instability have been difficult to interpret, either because the study setting has included both first-time and recurrent dislocations, or because a lack of control group. Moreover, several studies have enrolled patients with a wide age range, and the majority of the studies have employed retrospective and nonrandomized study designs. Therefore the investigators designed a prospective, randomized study with the primary goal to compare the outcome after MPFL reconstruction with medial reefing for chronic patellar instability. The distance between tibial tubercle and trochlear groove is measured on MRI and corrected if it exceeds 17mm. Primary outcome measure is the occurrence of recurrent objective and subjective patellar instability. The second goal is to evaluate the development of articular cartilage lesions within the patellofemoral joint, and assess clinical scores.

Official Title
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A Prospective Randomized Study of Medial Patellofemoral Ligament Reconstruction Compared With Medial Reefing

Conditions
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Patella-Dislocation, Patellofemoral Osteoarthritis, Patellar Instability

Intervention / Treatment
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* Procedure: Patellofemoral stabilizing surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic patellar instability (more than 2 dislocations) Minimum 6 months nonoperative treatment Exclusion Criteria: Severe PF OA Acute patellar dislocation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Medial patellofemoral ligament reconstruction | Procedure: Patellofemoral stabilizing surgery<br>* Comparison of surgical techniques<br>|
| Active Comparator: 2<br>Medial reefing | Procedure: Patellofemoral stabilizing surgery<br>* Comparison of surgical techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent patellar instability |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patellofemoral osteoarthrosis progression. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dislocation, Patella, Knee, Medial Patellofemoral Ligament