Clinical trial NCT03968029: Does Wrapping With Bone Marrow Injection Enhance Healing of Meniscal Sutures Into the Avascular Area
Official title: Does Wrapping With Bone Marrow Injection Enhance Healing of Meniscal Sutures Into the Non-vascular Area: A Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meniscus Lesion
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 128
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in integrity and healing of meniscus repair
timeFrame: 12 and 24 months after treatment
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: baseline and 3, 12 and 24 months after treatment
measure: International Knee Documentation Committee Score (IKDC)
timeFrame: baseline and 3, 12 and 24 months after treatment
measure: SF-12 Survey
timeFrame: baseline and 3, 12 and 24 months after treatment
measure: Failure rate
timeFrame: up to 24 months
Secondary outcomes:
measure: Change in integrity of meniscus and adjacent tissues (cartilage, bone, synovial tissue)
timeFrame: 12 months after treatment
measure: Rate of suture type-associated complications
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois - CHUV
state: Vaud
city: Lausanne
country: Switzerland
facility: Dr Robin MARTIN
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Robin MARTIN, MD
role: PRINCIPAL_INVESTIGATOR
References: