MRI follow up of bilateral partial meniscal substitution with a demineralized bone block. A case report.
Sven Behrendt
https://pubmed.ncbi.nlm.nih.gov/36324835Actively Recruiting
Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06376422
Sterile Allogeneic Spongioflex ae Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss, an Investigator-Initiated Low Interventional Trial
Led by Sven Behrendt · Updated on 2025-08-06
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to learn if partial meniscal replacement can improve knee function and delay or avoid the need for total meniscal replacement or knee prosthesis in adults with partial meniscal loss. The study compares patients who receive surgery with those who do not undergo surgery to see if the operation leads to better outcomes over time. Participants in the operated group will receive an arthroscopic surgery implanting a demineralized bone block called Spongioflex ae into the meniscus defect, secured with sutures. This biological implant is designed to support cell growth and restore meniscus function. The surgery lasts 60-90 minutes, with a hospital stay of 2-3 days. Follow-up visits occur at the end of the hospital stay, 6 weeks, and then at 6, 12, 24 months, and 5 years after surgery. The non-operated group does not receive surgery but has follow-up visits at 6, 12, 24 months, and 5 years. During the study, participants will undergo MRI scans and complete knee function and pain questionnaires at follow-up visits. Researchers will measure improvements in knee scores such as the International Knee Documentation Committee (IKDC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), and Visual Analogue Scale (VAS) for pain. Safety will be monitored by tracking adverse events, and other outcomes include meniscus size, extrusion, patient satisfaction, and progression to osteoarthritis. The total participation spans up to 5 years.
CONDITIONS
Brief Title
Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with partial loss of the lateral or medial meniscus and corresponding joint line pain
- Sufficient peripheral rim stability to allow the procedure
- Age between 18 and 60 years
- Signed informed consent to participate and provide scientific data in pseudonymized form
You will not qualify if you...
- Anterior cruciate ligament insufficiency not resolved by reconstruction within 16 weeks after implantation
- Axial deviation greater than 2° varus or valgus
- Realignment osteotomy not performed within 12 weeks
- Advanced cartilage damage (grade III) or osteoarthrosis in the affected compartment (grade III)
- Extension deficit over 3° compared to opposite side or knee flexion less than 125°
- Inflammatory arthritis or synovitis in the treated knee
- Body Mass Index over 30 kg/m²
- Age under 18 or over 60 years
- Chronic pain patients
- For operated patients: increased anesthesiologic risk, bleeding risk, infection risk, necrotic or poorly perfused host sites, history of allergic reactions, acute hypersensitivity to the implant or its components, or pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Surgery lasts between 60-90 minutes followed by a hospital stay of 2 to 3 days
Participants undergo arthroscopic surgery to implant a Spongioflex® allograft as a partial meniscal replacement. The implant is adapted to the defect size and secured with sutures.
1 surgery visit and hospital stay of 2 to 3 days
Post-operative Follow-up
Duration - Up to 5 years
Participants who received the implant have follow-up visits to monitor recovery, including MRI evaluations and questionnaires to assess knee function and pain.
Follow-up visits at hospital discharge, 6 weeks, 6 months, 12 months, 24 months, and 5 years
Long-term Monitoring
Duration - Up to 5 years
Participants who do not undergo surgery have follow-up visits to monitor their condition with MRI and questionnaires over time.
Follow-up visits at 6 months, 12 months, 24 months, and 5 years
Trial Site Locations
Total: 1 location
1
Privatpraxis für Knie und Schulterchirurgie
Dortmund, Germany, 44137
Actively Recruiting
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Research Team
S
Sven Behrendt, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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