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

Does Wrapping With Bone Marrow Injection Enhance Healing of Meniscal Sutures Into the Non-vascular Area: A Prospective Randomised Study

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

Study Overview

• Status: Completed
• Conditions: Meniscus Lesion
• Intervention / Treatment: Procedure: suturing meniscal augmented; Procedure: suturing meniscal

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois - CHUV
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • Dr Robin MARTIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suturing meniscal augmented; Non-vascularised area meniscus tear was sutured and bone marrow was injected under a protective collagen membrane (ChondroGide)	Procedure: suturing meniscal augmented; meniscal tear sutured + bone marrow injection/collagen membrane; Other Names: meniscal wrapping
Active Comparator: Suturing meniscal; Non-vascularised area meniscus tear was only sutured	Procedure: suturing meniscal; meniscal tear sutured

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in integrity of meniscus and adjacent tissues (cartilage, bone, synovial tissue)	Imaging: MRI	12 months after treatment
Rate of suture type-associated complications	Post-operative data collection: inflammation, pain, recurrent tear of the meniscus, instability or stiffness joint, perimeniscal cyst formation, hemarthrosis or effusion.	up to 24 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Robin MARTIN, MD, Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2017
• Primary Completion (Actual): March 19, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MW_OTR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No