Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss
Key facts
- Where
- Dortmund, GermanySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT06376422, who can take part
Where in Germany
- Privatpraxis für Knie und SchulterchirurgieDortmund, GermanyContact: Sven Behrendt, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sven Behrendt
- Trial code
- NCT06376422
- Record updated
- 15 October 2026
- Original description
The goal of this clinical trial is to learn if partial meniscal replacement can prevent or postpone total meniscal replacement, in adult patients (female/male) with partial meniscal loss. The main questions it aims to answer are:Read full original descriptionShow less
Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss, an Investigator-initiated Low Interventional Trial.
The goal of this clinical trial is to learn if partial meniscal replacement can prevent or postpone total meniscal replacement, in adult patients (female/male) with partial meniscal loss. The main questions it aims to answer are:
* Can partial meniscal replacement improve knee function? * Can partial meniscal replacement prevent/postpone total meniscal replacement/knee prothesis? Researchers will compare the results of the operated group with patients not willing to be operated but with partial meniscal loss to see if the operation improves knee function.
Participants will be operated and have to attend follow-up visits with MRI after 6 months up to 5 years after surgery.
Inclusion: 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.
Exclusion: 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; 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; <18 years, >60 years; 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; Chronic pain patients.