Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL)

Study Overview
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Brief Summary
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The purpose of this study is to elucidate surgical techniques for reconstructing MPFL in the treatment of chronic patella instability. The two techniques are conventional technique with the gracillis and screw fixation in the femur which is compared with new technique where the QT tendons and anchor fixation in the femur are used. It would be investigated which technique provides the best stability with the least postoperative pain from the reconstruction and the lowest frequency of patellar reluxation.

Official Title
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Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL) - A Randomized Controlled Trial.

Conditions
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Patellar Dislocation

Intervention / Treatment
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* Procedure: Quadriceps graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 15 and 40 years of age with chronic tendency to lateral patellar dislocation (defined as 2 or more verified dislocation cases) The growth zones must be found closed - verified by MRI scan Exclusion Criteria: Patients with known rheumatoid arthritis. Patients with arthroscopically detected osteoarthritis (grade 3 cartilage lesion) Inability to follow a normal rehabilitation regime. Previous ligament surgery in injured knees.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Standard: Gracillis graft Intervention: Quadriceps graft
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MPFL reconstruction with gracillis graft<br>MPFL reconstructrion with gracillis graft and screw fixation in femur | Procedure: Quadriceps graft<br>* Using quadriceps graft as new medial patellofemoral ligament graft. Fixated with suture anchor<br>|
| Experimental: MPFL reconstruction with quadriceps graft<br>MPFL reconstructrion with quadriceps graft and suture anchor fixation in femur | Procedure: Quadriceps graft<br>* Using quadriceps graft as new medial patellofemoral ligament graft. Fixated with suture anchor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kujala (Anterior Knee Pain Scale) | Patient reported outcome score, 0=worst and 100=best | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donor site morbidity score, 0=worst and 100=best | Patient reported outcome score | 24 month | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) | Patient reported outcome score, 0=worst and 100=best | 24 month | 
| Lysholm-Tegner (Activity Score) | Patient reported outcome score, 0=worst and 100=best | 24 month | 
| Numerical Rating Scale (NRS-pain score) | Patient reported outcome score, 0=Best and 10=worst | 24 month | 
| Knee pain | Palpatory pain in relation to graft fixation in femur on a four-point likert scale (no pain, mild pain, moderate pain, severe pain) | 24 month | 
| Patella Re-luxation sensation | Question about how often the patella has dislocated after the surgery. (no dislocation, 1-2 dislocation/md, more dislocation). | 24 month |