Clinical trial NCT05053646: This is a Study to Verify if Marrow Venting Procedure Can Improve Meniscal Suture Healing
Official title: Biological Augmentation Of Meniscal Repair With Marrow Venting: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meniscal Tear
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: subjective International Knee Documentation Committee (IKDC) score
timeFrame: 2 years
Secondary outcomes:
measure: Objective International Knee Documentation Committee (IKDC)
timeFrame: (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
measure: Lysholm score (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
timeFrame: (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
measure: Knee Injury and Osteoarthritis Outcome Score - KOOS
timeFrame: (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
measure: Pain 0-10 Numerical Rating Scale (NRS)
timeFrame: (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
measure: Function 0-10 Numerical Rating Scale (NRS)
timeFrame: (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
measure: Tegner score
timeFrame: (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)
measure: Healing rate
timeFrame: 1 year
measure: Treatment related adverse events
timeFrame: 5 years
measure: Function curves during the first 6 weeks.
timeFrame: 6 weeks
measure: Pain curves during the first 6 weeks.
timeFrame: 6 weeks
measure: Radiographic progression of knee osteoarthritis
timeFrame: 5 years
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Ente Ospedaliero Cantonale
city: Lugano
country: Switzerland
facility: Clinica Ars Medica
Study officials:
affiliation: Ente Ospedaliero Cantonale, Bellinzona
name: Christian Candrian, MD
role: PRINCIPAL_INVESTIGATOR
References:
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