Actively Recruiting
Partial Meniscal Replacement with Spongioflex®
Led by Maria-Josef-Hospital Greven · Updated on 2025-01-15
40
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this investigator-initiated trial is to evaluate whether the novel graft can prevent/reduce the disadvantages of the previously used replacement materials and shows better results than the group of patients, which were not operated. Since there is currently no alternative made of biological material to this product, this investigator-initiated trial is of great medical and economic importance. The otherwise following arthrosis or knee prosthesis implantation (TKA ) could be prevented or at least postponed. Initial clinical results are promising. An important and sensitive parameter for assessing the postoperative function of the meniscus is the MRI image. Genovese et al. 2007 were able to show in a categorization/classification which magnetic resonance image can be expected in the case of successful incorporation. Several studies have shown that the known clinical knee scores (Lysholm, IKDC, KOOS, VAS pain) improve significantly after successful ingrowth of the meniscus implant.
CONDITIONS
Official Title
Partial Meniscal Replacement with Spongioflex®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 60 years
- Partial loss of lateral meniscus with lateral joint line pain or medial meniscus with medial joint line pain
- Sufficient standing of the peripheral rim to allow the procedure
- Signed written informed consent to participate and provide scientific data in pseudonymized form
You will not qualify if you...
- Unresolved anterior cruciate ligament insufficiency within 16 weeks after implantation
- Knee axial deviation greater than 2� varus or valgus
- Realignment osteotomy not performed within 12 weeks
- Advanced cartilage damage (grade III ICRS) or osteoarthrosis (grade III Kellgren and Lawrence) in affected compartment
- Extension deficit over 3� compared to opposite side or knee flexion less than 125�
- Inflammatory arthritis or synovitis of the treated knee
- Body Mass Index over 30 kg/m�
- Chronic pain patients
- Age under 18 or over 60 years
- Increased anesthesiologic risk, bleeding risk, or infection risk for operated patients
- Necrotic, infected, or poorly perfused host tissue
- History of allergic reactions
- Acute hypersensitivity to the implant or its excipients
- Pregnant women
AI-Screening
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Trial Site Locations
Total: 1 location
1
Maria-Josef-Hospital Greven GmbH
Greven, North Rhine-Westphalia, Germany, 48268
Actively Recruiting
Research Team
C
Clemens Kösters, PD, Dr. med.
CONTACT
D
Daniel A den Toom, Dr. med
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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