Partial Meniscal Replacement with Spongioflex®
Recruiting now · Phase 4
Conditions studied: Partial Meniscal Loss, Lateral Meniscus Partial Loss, Medial Meniscal Partial Loss, Meniscus Lesion, Meniscal Injuries, Meniscal Tear
In brief
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.
Key facts
- Study ID
- NCT06775197
- Run by
- Maria-Josef-Hospital Greven
- People needed
- 40
- Starts
- 2024-11-05
- Expected to finish
- 2031-11-05
- Last updated by the study team
- 2025-01-15
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients (male and female) with:
- Partial loss of portions of the
- lateral meniscus and lateral joint line pain OR
- medial meniscus and medial joint line pain
- sufficient standing of the peripheral rim, so that the procedure can be performed
- Age: 18-60 years
- signed written informed consent to the study and to provide the scientific data in pseudonymized form
You may not qualify if…
- The presence of anterior cruciate ligament insufficiency which is not resolved by reconstruction of the anterior cruciate ligament within 16 weeks after partial meniscal implantation.
- Axial deviation (>2° varus or valgus)
- realignment osteotomy not performed within 12 weeks
- advanced cartilage damage (grade III according to ICRS) and osteoarthrosis in the affected compartment (grade III according to Kellgren and Lawrence [33])
- Extension deficit of more than 3° compared to the opposite side or a knee flexion of less than 125°
- inflammatory arthritis or synovitis on the treated knee
- BMI greater than 30 kg/m²
- <18 years, >60 years
- Chronic pain patients
- only for patients who will be operated:
- with increased anaesthesiologic risk, e.g., with known or predicted difficult airway
- with increased risk of bleeding
- with increased risk of infection
- with necrotic, infected, or poorly perfused host sides
- history of allergic reactions
- acute hypersensitivity reactions to the IMP or any of its excipients
- pregnant woman
Where it is running
- Maria-Josef-Hospital Greven GmbH — Greven, North Rhine-Westphalia, Germany (enrolling)
Full record on ClinicalTrials.gov
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