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

Meniscus Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03968029
• Other study ID #: MW_OTR
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Robin MARTIN, MD
• Phone: 021 314 76 79
• Email: robin.martin[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Meniscus Lesion

Intervention

Procedure:
• suturing meniscal augmented
meniscal tear sutured + bone marrow injection/collagen membrane
• suturing meniscal
meniscal tear sutured

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois - CHUV	Lausanne	Vaud
Switzerland	Dr Robin MARTIN	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in integrity and healing of meniscus repair	Arthrography (arthro-CT)	12 and 24 months after treatment
Primary	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
Primary	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
Primary	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
Primary	Failure rate	Number of readmission for meniscus tear	up to 24 months
Secondary	Change in integrity of meniscus and adjacent tissues (cartilage, bone, synovial tissue)	Imaging: MRI	12 months after treatment
Secondary	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