Meniscus Lesion
Conditions
Brief summary
This study will compare meniscal healing of non-vascularised area augmented or not by bone marrow injected under a protective collagen membrane (meniscal wrapping)
Detailed description
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.
Interventions
PROCEDUREsuturing meniscal augmented
meniscal tear sutured + bone marrow injection/collagen membrane
PROCEDUREsuturing meniscal
meniscal tear sutured
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in integrity and healing of meniscus repair | 12 and 24 months after treatment | Arthrography (arthro-CT) |
| Knee injury and Osteoarthritis Outcome Score (KOOS) | baseline and 3, 12 and 24 months after treatment | Changes in the 5 subscales of KOOS as assessed from baseline to 24 months post-surgery |
| International Knee Documentation Committee Score (IKDC) | baseline and 3, 12 and 24 months after treatment | Change in physical pain and function as assessed by IKDC score from baseline to 24 months post-surgery |
| SF-12 Survey | baseline and 3, 12 and 24 months after treatment | Change in functional health and well-being as assessed by SF-12 Survey from baseline to 24 months post-surgery |
| Failure rate | up to 24 months | Number of readmission for meniscus tear |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in integrity of meniscus and adjacent tissues (cartilage, bone, synovial tissue) | 12 months after treatment | Imaging: MRI |
| Rate of suture type-associated complications | up to 24 months | Post-operative data collection: inflammation, pain, recurrent tear of the meniscus, instability or stiffness joint, perimeniscal cyst formation, hemarthrosis or effusion. |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORRobin MARTIN, MD
Centre Hospitalier Universitaire Vaudois
Outcome results
None listed