Meniscus Lesion
Conditions
Keywords
meniscus repair, bone marrow stimulation
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.
Interventions
PROCEDUREwith microfractures
following meniscal repair, microfractures will be created on the intercondylar and outer part of femoral condyle (outside of joint surface), lateral or medial, respectively
PROCEDUREwithout microfractures
standard procedure meniscal repair without augmentation.
Sponsors
Centre of Postgraduate Medical Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Second look arthroscopy (assessment of meniscal healing integrity during second look) | 8-18 weeks | The primary outcome measures will be assessment of meniscal healing integrity during second look arthroscopy 3-5 months post repair. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op | Pain Visual Analog Scale. |
| Knee injury and Osteoarthritis Outcome Score scale | 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op | Knee injury and Osteoarthritis Outcome Score |
| International Knee Documentation Committee - Subjective Knee Evaluation Form | 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op | International Knee Documentation Committee - Subjective Knee Evaluation Form |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 6 weeks, 12 weeks, 6mts, 1yr post op, 2yrs post op, 3 yrs post op | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
Countries
Poland
Outcome results
None listed