MPFLR With Fascia Lata Allograft, Based on Isometry Assessment + Elmslie-Trillat TTO

Study Overview
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Brief Summary
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The aim of this study is to assess outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.

Detailed Description
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Medial Patellofemoral Ligament (MPFL) injury occurs in more than 95% of lateral patellar dislocations. Most of these injuries result in subsequent lateral patellar instability. Therefore, MPFL reconstruction (MPFLR) is often necessary. The aim of this study is to assess outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy. The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC), the Knee injury and Osteoarthritis Outcome Score (KOOS) and retear rate.

Official Title
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Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.

Conditions
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Lateral Patellofemoral Dislocation Closed Traumatic, Lateral Patellar Luxation

Intervention / Treatment
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* Procedure: Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lateral patellar dislocation with subsequent instability Failure of non-operative treatment Exclusion Criteria: Active inflammation of the knee; Previous surgeries on the patellofemoral joint; Fractures around the knee

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main arm of the study<br>Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy will be performed in these patients. | Procedure: Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.<br>* Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy. Management of any accompanying patellofemoral lesions will be performed as well.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lateral patella stability - apprehension test | Apprehension test at 30 degrees of knee flexion | At the 12 month of the follow-up. | 
| Lateral patella stability - lateral luxation test | Lateral luxation test at 30 degrees of knee flexion | At the 12 month of the follow-up. | 
| Lateral patella stability - apprehension test | Apprehension test at 30 degrees of knee flexion | At the 24 month of the follow-up. | 
| Lateral patella stability - lateral luxation test | Lateral luxation test at 30 degrees of knee flexion | At the 24 month of the follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) | Min of 0 max of 87 points, higher scores mean a better outcome | At the 12 month of the follow-up. | 
| The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC) | Min of 0 max of 87 points, higher scores mean a better outcome | At the 24 month of the follow-up. | 
| The functional assessment with the Knee injury and Osteoarthritis Outcome Score | Min of 0 max of 100 points, higher scores mean a better outcome | At the 12 month of the follow-up. | 
| The functional assessment with the Knee injury and Osteoarthritis Outcome Score | Min of 0 max of 100 points, higher scores mean a better outcome | At the 24 month of the follow-up. | 
| ROM | Knee range of motion assessed by the means of goniometer. | At the 12 month of the follow-up. | 
| ROM | Knee range of motion assessed by the means of goniometer. | At the 24 month of the follow-up. |