Augmentation of Meniscal Repair With Bone Marrow Stimulation Techniques (Microfractures): a Double Blind, Prospective, Randomized Clinical Trial of Efficacy and Safety.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Second look arthroscopy (assessment of meniscal healing integrity during second look)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
with microfractures
Standardized meniscal repair with bone marrow stimulation techniques (microfractures)
Intervention: with microfractures (Procedure)
without microfractures
Standardized meniscal repair without augmentation
Intervention: without microfractures (Procedure)
Outcomes
Primary Outcomes
Second look arthroscopy (assessment of meniscal healing integrity during second look)
Time Frame: 8-18 weeks
The primary outcome measures will be assessment of meniscal healing integrity during second look arthroscopy 3-5 months post repair.
Secondary Outcomes
- 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(6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op)
- 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)(6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op)
Investigators
Rafał Kamiński
M.D. Ph.D.
Centre of Postgraduate Medical Education