Augmentation of Meniscal Repair With Marrow Stimulation Techniques (Microfractures)

Study Overview
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Brief Summary
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This study will compare meniscal healing augmented or without augmentation with bone marrow stimulation techniques The assessments will include validated, disease specific, patient oriented outcome measures, second look arthroscopy during second step ACL reconstruction. Results of this study will help ascertain whether microfractures improve meniscal healing rates.

Detailed Description
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The role of meniscal in the knee integrity is pivotal and lack or partial role of the meniscus increases rate of joint degeneration. Partial meniscal removal is the most popular procedure and meniscal repair remain in minority of arthroscopic surgeries. As criteria of inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in the 60-80% range for isolated repairs. This rate is greater when performed with ACL reconstruction. We believe that augmentation with bone marrow stimulation techniques will induce more complete and possibly faster healing.

Official Title
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Augmentation of Meniscal Repair With Bone Marrow Stimulation Techniques (Microfractures): a Double Blind, Prospective, Randomized Clinical Trial of Efficacy and Safety.

Conditions
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Meniscus Lesion

Intervention / Treatment
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* Procedure: with microfractures
* Procedure: without microfractures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complete vertical longitudinal tear > 10 mm in length Tear located in the vascular portion of the meniscus, only in red-white zone Unstable peripheral tear Single tear of the medial and/or lateral meniscus Meniscal injury 1 -18 month prior surgery Planned second step arthroscopy (ACL reconstruction) Skeletally mature patients 18-55 years of age Exclusion Criteria: discoid meniscus arthritic changes (Kellgren Lawrence scale >2) non repairable meniscus degenerative or presence of crystals in meniscus concomitant procedure (acl reconstruction, microfracturing, trephination) inflammatory diseases (i.e. rheumatoid arthritis)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with microfractures<br>Standardized meniscal repair with bone marrow stimulation techniques (microfractures) | Procedure: with microfractures<br>* following meniscal repair, microfractures will be created on the intercondylar and outer part of femoral condyle (outside of joint surface), lateral or medial, respectively<br>|
| Placebo Comparator: without microfractures<br>Standardized meniscal repair without augmentation | Procedure: without microfractures<br>* standard procedure meniscal repair without augmentation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Second look arthroscopy (assessment of meniscal healing integrity during second look) | The primary outcome measures will be assessment of meniscal healing integrity during second look arthroscopy 3-5 months post repair. | 8-18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | Pain Visual Analog Scale. | 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op | 
| Knee injury and Osteoarthritis Outcome Score scale | Knee injury and Osteoarthritis Outcome Score | 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op | 
| International Knee Documentation Committee - Subjective Knee Evaluation Form | International Knee Documentation Committee - Subjective Knee Evaluation Form | 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op | 
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meniscus repair, bone marrow stimulation