Meniscus Lesion Clinical Trial
Official title:
Does Wrapping With Bone Marrow Injection Enhance Healing of Meniscal Sutures Into the Non-vascular Area: A Prospective Randomised Study
NCT number | NCT03968029 |
Other study ID # | MW_OTR |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 28, 2017 |
Est. completion date | December 31, 2024 |
This study will compare meniscal healing of non-vascularised area augmented or not by bone marrow injected under a protective collagen membrane (meniscal wrapping)
Status | Recruiting |
Enrollment | 128 |
Est. completion date | December 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 45 Years |
Eligibility | Inclusion Criteria: - Symptomatic or traumatic tears of medial or lateral meniscus; - Tearing affecting: only 2/3 central (= avascular zone) over more than 1 cm OR extending from the peripheral third (= vascularized area) within the avascular zone over more than 1 cm. In this case, preservation of the peripheral third over a width of at least 4 mm from the capsule; - Single or multiple tears. Exclusion Criteria: - Meniscal tears that can not be sutured, reduced / approximated - Tear creating a meniscal root avulsion - Partial meniscal tears - Meniscal tears already sutured - Cartilage damage in the compartment> grade 2 (ICRS classification) - Mechanical axis (varus / valgus) = 2 ° - Untreated ligament deficiency - Osteotomy and / or concomitant ligament reconstruction, with the exception of ACL reconstruction. - Compromised general health condition (score ASA score> 2) - BMI =30 - Active smoking, drug use - Allergy to porcine collagen - Poor compliance |
Country | Name | City | State |
---|---|---|---|
Switzerland | Centre Hospitalier Universitaire Vaudois - CHUV | Lausanne | Vaud |
Switzerland | Dr Robin MARTIN | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Vaudois |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in integrity and healing of meniscus repair | Arthrography (arthro-CT) | 12 and 24 months after treatment | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Failure rate | Number of readmission for meniscus tear | up to 24 months | |
Secondary | Change in integrity of meniscus and adjacent tissues (cartilage, bone, synovial tissue) | Imaging: MRI | 12 months after treatment | |
Secondary | 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. | up to 24 months |
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