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

Sponsor
Centre Hospitalier Universitaire Vaudois (Other)
Overall Status
Recruiting
CT.gov ID
NCT03968029
Collaborator
(none)
128
Enrollment
2
Locations
2
Arms
48.1
Anticipated Duration (Months)
64
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Procedure: suturing meniscal augmented
  • Procedure: suturing meniscal
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Does Wrapping With Bone Marrow Injection Enhance Healing of Meniscal Sutures Into the Non-vascular Aera: A Prospective Randomised Study
Actual Study Start Date :
Jul 28, 2017
Anticipated Primary Completion Date :
Jul 31, 2021
Anticipated Study Completion Date :
Jul 31, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in integrity and healing of meniscus repair [12 and 24 months after treatment]

      Arthrography (arthro-CT)

    2. Knee injury and Osteoarthritis Outcome Score (KOOS) [baseline and 3, 12 and 24 months after treatment]

      Changes in the 5 subscales of KOOS as assessed from baseline to 24 months post-surgery

    3. International Knee Documentation Committee Score (IKDC) [baseline and 3, 12 and 24 months after treatment]

      Change in physical pain and function as assessed by IKDC score from baseline to 24 months post-surgery

    4. SF-12 Survey [baseline and 3, 12 and 24 months after treatment]

      Change in functional health and well-being as assessed by SF-12 Survey from baseline to 24 months post-surgery

    5. Failure rate [up to 24 months]

      Number of readmission for meniscus tear

    Secondary Outcome Measures

    1. Change in integrity of meniscus and adjacent tissues (cartilage, bone, synovial tissue) [12 months after treatment]

      Imaging: MRI

    2. Rate of suture type-associated complications [up to 24 months]

      Post-operative data collection: inflammation, pain, recurrent tear of the meniscus, instability or stiffness joint, perimeniscal cyst formation, hemarthrosis or effusion.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Universitaire Vaudois - CHUV Lausanne Vaud Switzerland 1011
    2 Dr Robin MARTIN Lausanne Vaud Switzerland 1011

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire Vaudois

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Robin Martin, Principal Investigator, Centre Hospitalier Universitaire Vaudois
    ClinicalTrials.gov Identifier:
    NCT03968029
    Other Study ID Numbers:
    • MW_OTR
    First Posted:
    May 30, 2019
    Last Update Posted:
    Aug 4, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 4, 2021