Actively Recruiting
Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss
Led by Sven Behrendt · Updated on 2025-08-06
40
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if partial meniscal replacement can prevent or postpone total meniscal replacement, in adult patients (female/male) with partial meniscal loss. The main questions it aims to answer are: * Can partial meniscal replacement improve knee function? * Can partial meniscal replacement prevent/postpone total meniscal replacement/knee prothesis? Researchers will compare the results of the operated group with patients not willing to be operated but with partial meniscal loss to see if the operation improves knee function. Participants will be operated and have to attend follow-up visits with MRI after 6 months up to 5 years after surgery.
CONDITIONS
Official Title
Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients (male and female) with partial loss of the lateral meniscus and lateral joint line pain or partial loss of the medial meniscus and medial joint line pain
- Sufficient standing of the peripheral rim to allow the procedure
- Age between 18 and 60 years
- Signed written 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 partial meniscal implantation
- Axial deviation greater than 2 degrees varus or valgus
- Realignment osteotomy not performed within 12 weeks
- Advanced cartilage damage (grade III ICRS) or osteoarthrosis (grade III Kellgren and Lawrence) in the affected compartment
- Extension deficit over 3 degrees compared to opposite side or knee flexion less than 125 degrees
- Inflammatory arthritis or synovitis in the treated knee
- Body Mass Index greater than 30 kg/m2
- Age under 18 or over 60 years
- Chronic pain patients
- For operated patients: increased anesthesia risk, increased bleeding or infection risk, necrotic or poorly perfused host sites
- History of allergic reactions or acute hypersensitivity to the implant or its components
- Pregnant women
AI-Screening
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Trial Site Locations
Total: 1 location
1
Privatpraxis für Knie und Schulterchirurgie
Dortmund, Germany, 44137
Actively Recruiting
Research Team
S
Sven Behrendt, MD
CONTACT
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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