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This study will compare meniscal healing of non-vascularised area augmented or not by bone marrow injected under a protective collagen membrane (meniscal wrapping)
Historically, meniscus was considered as none essential for knee joint, and its removal by meniscectomy was the first-line treatment. Many studies have shown a negative progress towards osteoarthritis after meniscus ablation. This approach has gradually changed to preserve this meniscal capital, making way for new treatments as sutures. However the vascular organization of the meniscus is crucial for its cure. The healing potential of lesions in the meniscus non-vascularised aera is considered insufficient, and are often treated by a partial meniscectomy, resulting in a high risk of osteoarthritis. It appears therefore necessary to develop new strategies, as meniscal wrapping, to preserve meniscus presenting this type of damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suturing meniscal augmented | Experimental | Non-vascularised area meniscus tear was sutured and bone marrow was injected under a protective collagen membrane (ChondroGide) |
|
| Suturing meniscal | Active Comparator | Non-vascularised area meniscus tear was only sutured |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suturing meniscal augmented | Procedure | meniscal tear sutured + bone marrow injection/collagen membrane |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in integrity and healing of meniscus repair | Arthrography (arthro-CT) | 12 and 24 months after treatment |
| Knee injury and Osteoarthritis Outcome Score (KOOS) | Changes in the 5 subscales of KOOS as assessed from baseline to 24 months post-surgery | baseline and 3, 12 and 24 months after treatment |
| International Knee Documentation Committee Score (IKDC) | Change in physical pain and function as assessed by IKDC score from baseline to 24 months post-surgery | baseline and 3, 12 and 24 months after treatment |
| SF-12 Survey | Change in functional health and well-being as assessed by SF-12 Survey from baseline to 24 months post-surgery | baseline and 3, 12 and 24 months after treatment |
| Failure rate | Number of readmission for meniscus tear | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in integrity of meniscus and adjacent tissues (cartilage, bone, synovial tissue) | Imaging: MRI | 12 months after treatment |
| Rate of suture type-associated complications | Post-operative data collection: inflammation, pain, recurrent tear of the meniscus, instability or stiffness joint, perimeniscal cyst formation, hemarthrosis or effusion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin MARTIN, MD | Centre Hospitalier Universitaire Vaudois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois - CHUV | Lausanne | Canton of Vaud | 1011 | Switzerland | ||
| Dr Robin MARTIN |
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| suturing meniscal | Procedure | meniscal tear sutured |
|
| up to 24 months |
| Lausanne |
| Canton of Vaud |
| 1011 |
| Switzerland |