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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-28

Study Completion Date

2024-12-31

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)

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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.

Conditions

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Meniscus Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Suturing meniscal augmented

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

Group Type EXPERIMENTAL

suturing meniscal augmented

Intervention Type PROCEDURE

meniscal tear sutured + bone marrow injection/collagen membrane

Suturing meniscal

Non-vascularised area meniscus tear was only sutured

Group Type ACTIVE_COMPARATOR

suturing meniscal

Intervention Type PROCEDURE

meniscal tear sutured

Interventions

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suturing meniscal augmented

meniscal tear sutured + bone marrow injection/collagen membrane

Intervention Type PROCEDURE

suturing meniscal

meniscal tear sutured

Intervention Type PROCEDURE

Other Intervention Names

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meniscal wrapping

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

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No