This is a Study to Verify if Marrow Venting Procedure Can Improve Meniscal Suture Healing
- Conditions
- Meniscal Tear
- Interventions
- Procedure: Meniscal repairProcedure: Marrow venting procedure
- Registration Number
- NCT05053646
- Lead Sponsor
- Christian Candrian
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Marrow venting arm Meniscal repair Meniscal suture associated with marrow venting procedure Marrow venting arm Marrow venting procedure Meniscal suture associated with marrow venting procedure Control arm Meniscal repair Meniscal suture alone, without marrow venting procedure
- Primary Outcome Measures
Name Time Method subjective International Knee Documentation Committee (IKDC) score 2 years evaluated subjective IKDC score 2-years after intervention in two groups
- Secondary Outcome Measures
Name Time Method Pain curves during the first 6 weeks. 6 weeks Pain curves during the first 6 weeks as retrieved by the values produced with the EOC EMApp.
Tegner score (prior to the injury (e.g. referred to the day before), pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years) Tegner score (prior to the injury (e.g. referred to the day before), pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
Lysholm score (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years) (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years) Lysholm score (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
Treatment related adverse events 5 years Treatment related adverse events: overall, intra-operative, short- (\<3 months), mid- (3 months, 2 years), long-term (\>2 years) adverse events
Knee Injury and Osteoarthritis Outcome Score - KOOS (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years) Knee Injury and Osteoarthritis Outcome Score - KOOS (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
Function 0-10 Numerical Rating Scale (NRS) (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years) Function 0-10 numerical rating scale - NRS (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
Healing rate 1 year Healing rate (MRI at 1 year)
Function curves during the first 6 weeks. 6 weeks Function curves during the first 6 weeks.
Radiographic progression of knee osteoarthritis 5 years Radiographic progression of knee osteoarthritis (x-ray at 5 years)
Objective International Knee Documentation Committee (IKDC) (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years) Objective IKDC - International Knee Documentation Committee (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
Pain 0-10 Numerical Rating Scale (NRS) (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years) Pain 0-10 numerical rating scale - NRS (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
Trial Locations
- Locations (2)
Clinica Ars Medica
🇨ðŸ‡Lugano, Switzerland
Ente Ospedaliero Cantonale
🇨ðŸ‡Lugano, Switzerland