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

Vaud University Hospital Center

Status: Enrolling

Conditions: Meniscus Lesion

Treatments: Procedure: suturing meniscal augmented; Procedure: suturing meniscal

Study type: Interventional

Funder types: Other

Identifiers

NCT03968029

MW_OTR

Details and patient eligibility

About

This study will compare meniscal healing of non-vascularised area augmented or not by bone marrow injected under a protective collagen membrane (meniscal wrapping)

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Suturing meniscal augmented

Experimental group

Description:

Non-vascularised area meniscus tear was sutured and bone marrow was injected under a protective collagen membrane (ChondroGide)

Treatment:

Procedure: suturing meniscal augmented

Suturing meniscal

Active Comparator group

Description:

Non-vascularised area meniscus tear was only sutured

Treatment:

Procedure: suturing meniscal