Prospective, Randomised, Double Blinded Trial Comparing Effectiveness of Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Meniscus Lesion
- Sponsor
- Centre of Postgraduate Medical Education
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Assessment of meniscal healing by MR scanning
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Rafał Kamiński
Deputy Chair of Division
Centre of Postgraduate Medical Education
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Assessment of meniscal healing by MR scanning
Time Frame: by 1 year
The primary outcome measures will be assessment of meniscal healing integrity by MR scanning
Secondary Outcomes
- Visual Analog Scale(12 weeks, 6months, 1year post procedure)
- Knee injury and Osteoarthritis Outcome Score scale(12 weeks, 6months, 1year post procedure)
- International Knee Documentation Committee - Subjective Knee Evaluation Form(12 weeks, 6months, 1year post procedure)