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

Phase 1

Recruiting

• Conditions: incomplete meniscal loss; MedDRA version: 20.0Level: PTClassification code: 10054948Term: Meniscus operation Class: 100000004865; MedDRA version: 20.0Level: LLTClassification code: 10012418Term: Derangement of meniscus not elsewhere classified Class: 10022117; MedDRA version: 20.0Level: LLTClassification code: 10012414Term: Derangement of anterior horn of medial meniscus Class: 10022117; MedDRA version: 20.1Level: LLTClassification code: 10030263Term: Old bucket handle tear of medial meniscus Class: 10022117; MedDRA version: 20.0Level: LLTClassification code: 10012420Term: Derangement of posterior horn of medial meniscus Class: 10022117; MedDRA version: 20.0Level: LLTClassification code: 10012415Term: Derangement of lateral meniscus Class: 10022117; MedDRA version: 20.1Level: LLTClassification code: 10031892Term: Other derangement of lateral meniscus Class: 10022117; MedDRA version: 20.0Level: LLTClassification code: 10012413Term: Derangement of anterior horn of lateral meniscus Class: 10022117; MedDRA version: 21.1Level: LLTClassification code: 10006534Term: Bucket handle tear of medial meniscus of knee Class: 10022117

• Registration Number: CTIS2023-508271-36-00
• Lead Sponsor: Dr. Sven Behrendt, Praxis für Kien und Schulterchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-23
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified