Biological Augmentation Of Meniscal Repair With Marrow Venting: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Christian Candrian
- Enrollment
- 80
- Locations
- 3
- Primary Endpoint
- subjective International Knee Documentation Committee (IKDC) score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 50 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control arm
Meniscal suture alone, without marrow venting procedure
Intervention: Meniscal repair (Procedure)
Marrow venting arm
Meniscal suture associated with marrow venting procedure
Intervention: Meniscal repair (Procedure)
Marrow venting arm
Meniscal suture associated with marrow venting procedure
Intervention: Marrow venting procedure (Procedure)
Outcomes
Primary Outcomes
subjective International Knee Documentation Committee (IKDC) score
Time Frame: 2 years
evaluated subjective IKDC score 2-years after intervention in two groups
Secondary Outcomes
- Pain curves during the first 6 weeks.(6 weeks)
- 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))
- Treatment related adverse events(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))
- Healing rate(1 year)
- Function curves during the first 6 weeks.(6 weeks)
- Radiographic progression of knee osteoarthritis(5 years)
- Objective International Knee Documentation Committee (IKDC)((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))
Investigators
Christian Candrian
Principal Investigator
Ente Ospedaliero Cantonale, Bellinzona