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

Christian Candrian

Status: Enrolling

Conditions: Meniscal Tear

Treatments: Procedure: Meniscal repair; Procedure: Marrow venting procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT05053646

ORL-ORT-019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Arthroscopic confirmed suturable meniscal tears,
• Monolateral meniscal tears,
• 18-45 years,
• BMI>18,5 and <35 kg/m2,
• Ability to give informed consent by signature.

Exclusion criteria

• Bilateral meniscal tears requiring treatment,
• Associated ligament lesions requiring treatment,
• Associated cartilage lesions (Outerbridge > 2),
• Knee axis deformities requiring correction
• Generalized ligamentous laxity,
• Radiographic knee ostheoarthritis,
• Other reasons for knee pain,
• Pregnant or lactating women,
• Serious systemic diseases such as cardiac, hepatic or renal failure, rheumatic diseases, non-compensated diabetic, psychological illnesses, central or peripheral neurological diseases, and autoimmune diseases,
• Enrolled in another ongoing clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Marrow venting arm

Experimental group

Description:

Meniscal suture associated with marrow venting procedure

Treatment:

Procedure: Marrow venting procedure

Procedure: Meniscal repair

Control arm

Active Comparator group

Description:

Meniscal suture alone, without marrow venting procedure

Treatment:

Procedure: Meniscal repair