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

Last updated: July 16, 2024
Sponsor: Christian Candrian
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Marrow venting procedure

Meniscal repair

Clinical Study ID

NCT05053646
ORL-ORT-019
  • Ages 16-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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, rheumaticdiseases, non-compensated diabetic, psychological illnesses, central or peripheralneurological diseases, and autoimmune diseases,

  • Enrolled in another ongoing clinical trial.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Marrow venting procedure
Phase:
Study Start date:
December 29, 2021
Estimated Completion Date:
October 01, 2030

Study 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.

Connect with a study center

  • Clinica Ars Medica

    Lugano,
    Switzerland

    Active - Recruiting

  • Ente Ospedaliero Cantonale

    Lugano, 6900
    Switzerland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.