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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with microfractures | Experimental | Standardized meniscal repair with bone marrow stimulation techniques (microfractures) |
|
| without microfractures | Placebo Comparator | Standardized meniscal repair without augmentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| with microfractures | Procedure | following meniscal repair, microfractures will be created on the intercondylar and outer part of femoral condyle (outside of joint surface), lateral or medial, respectively |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rafał Kamiński, M.D. Ph.D. | SPSK Prof A. Gruca Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education | Otwock | Woj. Mazowieckie | 05-400 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30902532 | Derived | Kaminski R, Kulinski K, Kozar-Kaminska K, Wasko MK, Langner M, Pomianowski S. Repair Augmentation of Unstable, Complete Vertical Meniscal Tears With Bone Marrow Venting Procedure: A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study. Arthroscopy. 2019 May;35(5):1500-1508.e1. doi: 10.1016/j.arthro.2018.11.056. Epub 2019 Mar 20. |
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| without microfractures | Procedure | standard procedure meniscal repair without augmentation. |
|
| 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 |