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Sterile allogeneic spongioflex® allografts as partial meniscal replacement after incomplete meniscal loss, an investigator initiated trial
EU CTIS ID: 2023-508271-36-00
What this study is testing
The objective is to improve the meniscus functionality. The efficacy of the procedure will be evalated using the PROMS (IKDC, KOOS, VAS-pain-score). The comparison of the PROMs between patients operated and not operated will be performed and a comparison between PROMs at the beginning of the study and after 2 and 5 years. The clinical trial will be conducted in compliance with the protocol, the CTR 536/2014 and with this Regulation and with the principles of good clinical practice.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.