Does Wrapping With Bone Marrow Injection Enhance Healing of Meniscal Sutures Into the Avascular Area

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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Does Wrapping With Bone Marrow Injection Enhance Healing of Meniscal Sutures Into the Non-vascular Area: A Prospective Randomised Study

Conditions
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Meniscus Lesion

Intervention / Treatment
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* Procedure: suturing meniscal augmented
* Procedure: suturing meniscal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suturing meniscal augmented<br>Non-vascularised area meniscus tear was sutured and bone marrow was injected under a protective collagen membrane (ChondroGide) | Procedure: suturing meniscal augmented<br>* meniscal tear sutured + bone marrow injection/collagen membrane<br>* Other names: meniscal wrapping;|
| Active Comparator: Suturing meniscal<br>Non-vascularised area meniscus tear was only sutured | Procedure: suturing meniscal<br>* meniscal tear sutured<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | up to 24 months |