Sterile allogeneic spongioflex® allografts as partial meniscal replacement after incomplete meniscal loss, an investigator-initiated trial

Dr. Sven Behrendt, Praxis für Kien und Schulterchirurgie0 sites30 target enrollmentSeptember 23, 2023

Overview

No summary available.

Registry

who.int

Start Date

September 23, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Dr. Sven Behrendt, Praxis für Kien und Schulterchirurgie

•Partial loss of portions of the lateral meniscus and lateral joint line pain OR \- Partial loss of the medial meniscus and medial joint line pain, Age 18\-60 years, written consent to the study and to provide the scientific data in pseudonymized form, sufficient standing of the peripheral rim, so that the procedure can be performed

•Presence of anterior cruciate ligament insufficiency that is not resolved by reconstruction of the anterior cruciate ligament within 16 weeks after partial meniscal implantation., Chronic pain patients, inflammatory arthritis or synovitis on the treated knee, only for patients who will be operated: \- with increased anesthesiological 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 or acute hypersensitivity reactions to the IMP or any of its excipients \- pregnant woman, 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 (Kellgren and Lawrence, 1957\), Extension deficit of more than 3° compared to the opposite side or a knee flexion of less than 125°, BMI greater than 30 kg/m², \<18 years, \>60 years, pregnancy (only for patients with surgery)