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Biological Augmentation of Meniscal Repair with Marrow Venting: A Randomized Controlled Trial
Led by Christian Candrian · Updated on 2025-08-06
80
Participants Needed
2
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Meniscal tears are common knee injuries that can cause pain, stiffness, and difficulty in daily activities. When conservative treatments do not work, surgical repair using meniscal sutures is preferred over removal of the meniscus. This trial evaluates whether adding a marrow venting procedure, which involves creating small micro-fractures in the bone near the meniscus, can improve healing outcomes compared to meniscal suture alone. The study aims to address limitations of previous trials by including tears in the red-white zone of the meniscus and testing this biological augmentation technique in a larger patient group. Participants will be randomly assigned to one of two groups: one receiving meniscal suture combined with the marrow venting procedure, and the other receiving meniscal suture alone without marrow venting. The meniscal repair involves trimming the damaged tissue and stitching the meniscus using a specialized system. For those in the marrow venting group, micro-fractures will be made at the bone in the intercondylar notch to allow marrow elements to enter the joint and potentially enhance healing. Throughout the study, participants will be followed and assessed at multiple time points up to five years after surgery. Evaluations include subjective and objective knee function scores, pain and function rating scales, healing rates, and monitoring for treatment-related adverse events. Researchers will also observe the progression of knee osteoarthritis through imaging. The study focuses on patient recovery and knee function improvement over time with detailed assessments before surgery and at intervals postoperatively.
CONDITIONS
Brief Title
This is a Study to Verify if Marrow Venting Procedure Can Improve Meniscal Suture Healing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Arthroscopic confirmed suturable meniscal tears
- Meniscal tears on one knee only
- Age between 18 and 45 years
- Body mass index (BMI) greater than 18.5 and less than 35 kg/m2
- Ability to provide informed consent by signature
You will not qualify if you...
- Meniscal tears on both knees requiring treatment
- Ligament injuries needing treatment
- Cartilage damage classified as Outerbridge grade greater than 2
- Knee alignment deformities requiring correction
- Generalized ligament looseness
- Radiographic evidence of knee osteoarthritis
- Other causes of knee pain
- Pregnancy or breastfeeding
- Serious systemic illnesses such as heart, liver, or kidney failure, rheumatic diseases, uncontrolled diabetes, psychological or neurological disorders, and autoimmune diseases
- Participation in another ongoing clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo meniscal repair surgery, with or without the marrow venting procedure, to facilitate healing of the meniscal tear.
1 surgical visit (in-person)
Duration - Up to 5 years
Participants attend follow-up visits to assess healing, pain, function, and adverse events after surgery.
Multiple follow-up visits at 6 weeks, 3 months, 6 months, 1 year, 2 years, and 5 years
Trial Site Locations
Total: 2 locations
1
Ente Ospedaliero Cantonale
Lugano, Switzerland, 6900
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2
Clinica Ars Medica
Lugano, Switzerland
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Research Team
C
Christian R Candrian, MD
G
Gabriela Induni-Lang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2