HUMAN CANCELLOUS BONE for Meniscus tear | Meniscus injury

Inclusion criteria

• {"criterion_text":"- 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\n- Age 18-60 years\n- written consent to the study and to provide the scientific data in pseudonymized form\n- sufficient standing of the peripheral rim, so that the procedure can be performed"}

Exclusion criteria

• {"criterion_text":"- Presence of anterior cruciate ligament insufficiency that is not resolved by reconstruction of the anterior cruciate ligament within 16 weeks after partial meniscal implantation.\n- Chronic pain patients\n- inflammatory arthritis or synovitis on the treated knee\n- 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\n- Axial deviation (>2° varus or valgus)\n- realignment osteotomy not performed within 12 weeks\n- 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)\n- Extension deficit of more than 3° compared to the opposite side or a knee flexion of less than 125°\n- BMI greater than 30 kg/m²\n- <18 years, >60 years\n- pregnancy (only for patients with surgery)"}

Primary endpoints

• {"endpoint_text":"- Improvement of PROMs (KOOS, IKDC, VAS Pain Score) 2 and 5 years after surgery compared to scores of the non-operated group and compared to pre-surgery scores.","definition_or_measurement_approach":"Measured using patient-reported outcome measures (PROMs): IKDC, KOOS, and VAS pain score; comparison between operated and non-operated groups and comparison to pre-surgery scores at 2 and 5 years."}

Secondary endpoints

• {"endpoint_text":"- Safety of the patient: Type, frequency and severity of treatment-related AEs and SAEs","definition_or_measurement_approach":"Assessment of adverse events and serious adverse events by type, frequency and severity related to treatment."}
• {"endpoint_text":"- Efficacy of the procedure: How many patients show a progression of osteoarthrosis up to TKA?","definition_or_measurement_approach":"Number/proportion of patients progressing to osteoarthrosis requiring total knee arthroplasty (TKA) over follow-up."}
• {"endpoint_text":"- MRI evaluation: Outerbridge graduation, size of meniscus, number of patients with extrusion, size of extrusion after 6 weeks, 6 and 12 months (for operated patients) and after 2 and 5 years, comparison between the operated and the non-operated group","definition_or_measurement_approach":"MRI assessments including Outerbridge grading, meniscus size, presence and size of extrusion at specified timepoints (6 weeks, 6 and 12 months, 2 and 5 years) with operated vs non-operated group comparisons."}
• {"endpoint_text":"- Patient satisfaction: very pleased, pleased, not pleased, very unsatisfied in the operated group after 2 and 5 years","definition_or_measurement_approach":"Patient-reported satisfaction categories collected in the operated group at 2 and 5 years."}

Germany

Earliest CTIS Part Ii Submission Date

11-03-2024

Latest Decision Or Authorization Date

04-04-2025

Processing Time Days

389

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Dr. Sven Behrendt, Knie und Schulterchirurgie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany