Effectiveness of Trephination With Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment

Study Overview
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Brief Summary
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This study will compare meniscal healing augmented or without augmentation with platelet rich plasma in primary meniscal tear treatment (prolotherapy). The assessments will include validated, disease specific, patient oriented outcome measures. Results of this study will help ascertain whether platelet rich plasma may 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. The investigators believe that augmentation with platelet rich plasma as prolotherapy ill induce healing without the need for arthroscopy.

Official Title
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Prospective, Randomised, Double Blinded Trial Comparing Effectiveness of Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment

Conditions
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Meniscus Lesion

Intervention / Treatment
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* Biological: trephination with placebo
* Biological: trephination with platelet rich plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complete horizontal 10 mm in length Tear located in the vascular/avascular portion of the meniscus (chronic horizontal tear on MR) Single tear of the medial and/or lateral meniscus Skeletally mature patients 18-70 years of age Exclusion Criteria: discoid meniscus arthritic changes (Kellgren Lawrence scale >2) or axial leg deformity (valgus > 6 deg) inflammatory diseases (i.e. rheumatoid arthritis) concominant chondral defects (> 2 ICRS)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: trephination with placebo<br>meniscal repair with trephination and placebo | Biological: trephination with placebo<br>* trephination under US guidance and placebo injection<br>|
| Experimental: trephination with platelet rich plasma<br>meniscal repair with trephination and platelet rich plasma | Biological: trephination with platelet rich plasma<br>* trephination under US guidance and platelet rich plasma injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of meniscal healing by MR scanning | The primary outcome measures will be assessment of meniscal healing integrity by MR scanning | by 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | Pain Visual Analog Scale. | 12 weeks, 6months, 1year post procedure | 
| Knee injury and Osteoarthritis Outcome Score scale | Knee injury and Osteoarthritis Outcome Score | 12 weeks, 6months, 1year post procedure | 
| International Knee Documentation Committee - Subjective Knee Evaluation Form | International Knee Documentation Committee - Subjective Knee Evaluation Form | 12 weeks, 6months, 1year post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meniscus repair, platelet rich plasma