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

Not Applicable

Recruiting

• Conditions: Meniscus Lesion

• Registration Number: NCT03968029
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Study Timeline

• Study Start: 2017-07-28
• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29
• Primary Completion: 2024-07-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Failure rate	up to 24 months	Number of readmission for meniscus tear
Change in integrity and healing of meniscus repair	12 and 24 months after treatment	Arthrography (arthro-CT)
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
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Centre Hospitalier Universitaire Vaudois - CHUV; 🇨🇭 Lausanne, Vaud, Switzerland

Dr Robin MARTIN; 🇨🇭 Lausanne, Vaud, Switzerland