NCT05053646

This is a Study to Verify if Marrow Venting Procedure Can Improve Meniscal Suture Healing

Biological Augmentation Of Meniscal Repair With Marrow Venting: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Christian Candrian · Academic / Other
• Sex: All
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Meniscal suture represents the current surgical practice, and marrow venting is a low risk procedure. Bone venting may be able to improve the outcome of meniscal repair, allowing the patient a better recovery.

Detailed description

Meniscal tears are one of the most common lesions of the knee and are a risk factor for the development of knee osteoarthritis. A meniscal tear commonly causes knee pain, stiffness, loss of function and sometimes catching or locking of the knee, affecting patients' ability to participate in their everyday activities. In case of ineffective conservative management, meniscal tears are treated with meniscectomy (partial or total) or meniscal repair, with the latter considered, when possible, the optimal choice. Meniscal repair consists of a suture that juxtaposes the flaps of the injured meniscus to facilitate the healing of the tear. Unfortunately, meniscal healing capability is limited. A higher rate of meniscal tears healing has been documented in patients treated simultaneously with a meniscal repair and anterior cruciate ligament reconstruction. A surgical augmentation technique performing micro-fractures on the medial aspect of the lateral femoral condyle during meniscal repair surgery has been developed to mimic the beneficial effect of anterior cruciate ligament reconstruction on the joint environment. This technique has been successfully tested in preclinical studies, in human cohort studies and, recently, in a randomized control trial. However, these randomised controlled trials present some methodological weaknesses, such as a low number of included patients, and included only full-thickness vertical longitudinal tears in the red-red zone, the meniscal tears with the highest healing potential. The effect of additional micro-fractures on the healing capacity of meniscal tears involving the red-white zone has never been tested.

Conditions

• Meniscal Tear

Interventions

Type	Name	Description
PROCEDURE	Meniscal repair	The meniscus is trimmed with an arthroscopic punch followed by an electric shaver to expose the margins of the tear and remove damaged tissue. Vertical sutures are made using TRUESPAN™ Meniscal Repair System (DePuy Synthes) to approximate both the femoral and tibial surfaces of the torn meniscus.
PROCEDURE	Marrow venting procedure	After meniscal repair, a bone marrow venting procedure will be performed: a 45° micro-fracture awl is repeatedly penetrated through the bone of the intercondylar notch at the PCL origin until marrow elements are seen to enter the joint.

Timeline

• Start date: 2021-12-29
• Primary completion: 2030-10-01
• Completion: 2030-10-01
• First posted: 2021-09-22
• Last updated: 2025-08-06

Locations

2 sites across 1 country: Switzerland