Medial Retinacular Plication Versus Medial Patellofemoral Ligament Reconstruction for Recurrent Patellar Instability

Study Overview
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Brief Summary
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The purpose of this study is to determine whether medial patellofemoral ligament reconstruction results in superior functional outcomes compared to medial retinacular plication surgery in cases of recurrent patellar instability.

Detailed Description
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Patients with recurrent lateral patellar instability will be assigned to undergo one of two surgical approaches aimed to prevent recurrent patellar instability and result in improvement in function. One surgical approach will be medial retinacular plication with multiple stitches while the other surgical approach will include medial patellofemoral ligament reconstruction using a hamstring tendon graft. Prior to surgery, and then during follow-up after surgery as well as at the completion of minimum two years follow-up after surgery, patients will be asked to complete subjective functional questionaires that will rate their knee function, and to undergo detailed physical examination and objective functional tests that will quantify the success of surgery. The outcomes of the surgical treatment options will be compared to determine whether medial patellofemoral ligament reconstruction results in superior function and patient subjective satisfaction compared to medial retinacular plication only.

Official Title
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Functional Outcome of Surgical Treatment for Recurrent Patellar Instability: A Prospective Comparative Study Between Medial Retinacular Plication Versus Medial Patellofemoral Ligament Reconstruction

Conditions
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Patella, Familial Recurrent Dislocation Of

Intervention / Treatment
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* Procedure: Surgical treatment for recurrent patellar instability


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recurrent lateral patellar instability has been described by the patient Imaging criteria include: TT-TG distance (on CT or MRI) is between 10-20 mm Insall-Salvati Index is between 0.9 - 1.2 Trochlea angle is lower than 145 degrees Exclusion Criteria: Only a single event of lateral patellar instability occured Imaging criteria include: TT-TG distance (on CT or MRI) is below 10 mm or above 20 mm Insall-Salvati Index is below 0.9 or above 1.2 Trochlea angle is above 145 degrees Other concomitant intra-articular patholgies, injuries, and surgeries, besides the patella instability, with were recorded at the lower limbs and did not uneventfuly healed, and as a result cause dysfunction of the lower limbs Significant ligamentous injuries of the knees, including cruciate and collateral injuries, as well as meniscal injuries that interfere with function

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 35 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Medial plication<br>Patient undergoing surgical treatment for recurrent patellar instability that includes medial retinacular plication | Procedure: Surgical treatment for recurrent patellar instability<br>* Either medial plication or MPFL reconstructuion surgery<br>|
| Other: MPFL reconstruction<br>Patient undergoing surgical treatment for recurrent patellar instability that includes medial patellofemoral ligament reconstruction using a tendon graft | Procedure: Surgical treatment for recurrent patellar instability<br>* Either medial plication or MPFL reconstructuion surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kujala knee outcome score | A validated international outcome score that evaluates knee functional outcome in relation to patellofemoral symptoms | Between two and five years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Documentation Committee subjective outcome score | A validated international outcome score that evaluates general knee functional outcome | Between two and five years after surgery | 
| Tenger activity level score | A validated international outcome score that evaluates highest level of sports activity | Between two and five years after surgery | 
| Marx activity level score | A validated international outcome score that evaluates highest level of sports activity | Between two and five years after surgery | 
| Visual Analogue Scale | A validated international scale that evaluates level of pain | Between two and five years after surgery | 
| Single hop test | Evaluates limb asymmetry index between operated and nonoperated limbs during a single legged hop for distance | Between two and five years after surgery | 
| Side-to-side hop test | Evaluates limb asymmetry index between operated and nonoperated limbs performing side to side repetaed hops during 30 seconds | Between two and five years after surgery | 
| Patellar apprehension test | Evaluates normal patellar tracking and patient's feeling of subjective comfort while the examiner apply a provocative force that translates the patella lateraly | Between two and five years after surgery | 
| Infectious event of the operated knee documented by number of events that required antibiotics treatment with or without joint lavage | Infection of the surgical site as a severe complication of surgery, requirng antibiotics with or without joint lavage | Immediately after surgery, for the duration of hospital stay, and until expected time of 1 month |