Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 69 of 1830 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03968029
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Robin Martin, Centre Hospitalier Universitaire Vaudois

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
Meniscus Lesion Procedure: suturing meniscal augmented Procedure: suturing meniscal Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 28, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2021

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 Name: meniscal wrapping

Active Comparator: Suturing meniscal
Non-vascularised area meniscus tear was only sutured
Procedure: suturing meniscal
meniscal tear sutured




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968029


Contacts
Layout table for location contacts
Contact: Robin MARTIN, MD 021 314 76 79 ext 41 robin.martin@chuv.ch

Locations
Layout table for location information
Switzerland
Centre Hospitalier Universitaire Vaudois - CHUV Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Robin MARTIN, MD    021 314 76 79 ext 41    robin.martin@chuv.ch   
Dr Robin MARTIN Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Robin Martin, MD    021 314 76 79 ext 41    robin.martin@chuv.ch   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Layout table for investigator information
Principal Investigator: Robin MARTIN, MD Centre Hospitalier Universitaire Vaudois

Layout table for additonal information
Responsible Party: Dr. Robin Martin, Principal Investigator, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT03968029     History of Changes
Other Study ID Numbers: MW_OTR
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No