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

NCT03968029 | Completed

• 1 other identifier: MW_OTR
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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)

Conditions

Meniscus Lesion

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Change in integrity of meniscus and adjacent tissues (cartilage, bone, synovial tissue)

  12 months after treatment

• Rate of suture type-associated complications

  up to 24 months

Study Arms (2)

Suturing meniscal augmented

EXPERIMENTAL

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

Procedure: suturing meniscal augmented

Suturing meniscal

ACTIVE COMPARATOR

Non-vascularised area meniscus tear was only sutured

Procedure: suturing meniscal

Interventions

suturing meniscal augmented PROCEDURE

meniscal tear sutured + bone marrow injection/collagen membrane

Also known as: meniscal wrapping

Suturing meniscal augmented

suturing meniscal PROCEDURE

meniscal tear sutured

Suturing meniscal

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (2)

Centre Hospitalier Universitaire Vaudois - CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Dr Robin MARTIN

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Study Officials

• Robin MARTIN, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 30, 2019
• Study Start: July 18, 2017
• Primary Completion: March 19, 2025
• Study Completion: December 31, 2025
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

CH (2)