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Completed

NCT Number: NCT03968029

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

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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Key information

Conditions

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois - CHUV, Lausanne, Canton of Vaud, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

suturing meniscal augmented

Procedure

meniscal tear sutured + bone marrow injection/collagen membrane

Other names: meniscal wrapping

suturing meniscal

Procedure

meniscal tear sutured

Primary outcomes

  1. Change in integrity and healing of meniscus repair

    Time frame: 12 and 24 months after treatment

    Arthrography (arthro-CT)

  2. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: up to 24 months

    Number of readmission for meniscus tear

Secondary outcomes

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

    Time frame: 12 months after treatment

    Imaging: MRI

  2. Rate of suture type-associated complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
May 30, 2019
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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