NCT06775197 Partial Meniscal Replacement with Spongioflex®
| NCT ID | NCT06775197 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Maria-Josef-Hospital Greven |
| Condition | Partial Meniscal Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-11-05 |
| Primary Completion | 2029-11-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2024-11-05 with a primary completion date of 2029-11-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this investigator-initiated trial is to evaluate whether the novel graft can prevent/reduce the disadvantages of the previously used replacement materials and shows better results than the group of patients, which were not operated. Since there is currently no alternative made of biological material to this product, this investigator-initiated trial is of great medical and economic importance. The otherwise following arthrosis or knee prosthesis implantation (TKA ) could be prevented or at least postponed. Initial clinical results are promising. An important and sensitive parameter for assessing the postoperative function of the meniscus is the MRI image. Genovese et al. 2007 were able to show in a categorization/classification which magnetic resonance image can be expected in the case of successful incorporation. Several studies have shown that the known clinical knee scores (Lysholm, IKDC, KOOS, VAS pain) improve significantly after successful ingrowth of the meniscus implant.
Eligibility Criteria
Inclusion Criteria: 1. Patients (male and female) with: 2. Partial loss of portions of the * lateral meniscus and lateral joint line pain OR * medial meniscus and medial joint line pain 3. sufficient standing of the peripheral rim, so that the procedure can be performed 4. Age: 18-60 years 5. signed written informed consent to the study and to provide the scientific data in pseudonymized form Exclusion Criteria: 1. 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. 2. Axial deviation (\>2° varus or valgus) 3. realignment osteotomy not performed within 12 weeks 4. advanced cartilage damage (grade III according to ICRS) and osteoarthrosis in the affected compartment (grade III according to Kellgren and Lawrence \[33\]) 5. Extension deficit of more than 3° compared to the opposite side or a knee flexion of less than 125° 6. inflammatory arthritis or synovitis on the treated knee 7. BMI greater than 30 kg/m² 8. \<18 years, \>60 years 9. Chronic pain patients 10. only for patients who will be operated: 1. with increased anaesthesiologic risk, e.g., with known or predicted difficult airway 2. with increased risk of bleeding 3. with increased risk of infection 4. with necrotic, infected, or poorly perfused host sides 5. history of allergic reactions 6. acute hypersensitivity reactions to the IMP or any of its excipients 7. pregnant woman
Contact & Investigator
Clemens Kösters, PD, Dr. med
PRINCIPAL INVESTIGATOR
Maria-Josef-Hospital Greven GmbH
Frequently Asked Questions
Who can join the NCT06775197 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Partial Meniscal Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06775197 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06775197 currently recruiting?
Yes, NCT06775197 is actively recruiting participants. Contact the research team at Clemens.Koesters@mjh-greven.de for enrollment information.
Where is the NCT06775197 trial being conducted?
This trial is being conducted at Greven, Germany.
Who is sponsoring the NCT06775197 clinical trial?
NCT06775197 is sponsored by Maria-Josef-Hospital Greven. The principal investigator is Clemens Kösters, PD, Dr. med at Maria-Josef-Hospital Greven GmbH. The trial plans to enroll 40 participants.