Partial meniscus replacement using Spongioflex®
Sterile Allogeneic Spongioflex® Allograft As Partial Meniscal Replacement After Incomplete Meniscal Loss, an Investigator-initiated Trial
This study is testing a new type of graft called Spongioflex® to see if it can help younger, active people with meniscus injuries recover better than with traditional methods and avoid future knee problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Maria-Josef-Hospital Greven Academic / other |
| Locations | 1 site (Greven, North Rhine-Westphalia) |
| Trial ID | NCT06775197 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a novel graft, Spongioflex®, for partial meniscal replacement in patients with meniscal injuries. The study aims to determine if this biological material can provide better outcomes compared to traditional replacement methods and prevent the progression to knee arthrosis or the need for knee prosthesis. Patients will undergo the procedure and their postoperative function will be assessed through MRI and clinical knee scores. The trial focuses on younger, active individuals with specific types of meniscal damage.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18-60 with partial loss of the lateral or medial meniscus and associated joint line pain.
Not a fit: Patients over 60 years old, those with significant knee instability, or advanced cartilage damage will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve knee function and delay the onset of arthritis in patients with meniscal injuries.
How similar studies have performed: While this approach is novel, previous studies have shown promising results with similar biological grafts in improving knee function.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Greven, North Rhine-Westphalia
- Maria-Josef-Hospital Greven GmbH — Greven, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Clemens Kösters, PD, Dr. med — Maria-Josef-Hospital Greven GmbH
- Study coordinator: Clemens Kösters, PD, Dr. med.
- Email: Clemens.Koesters@mjh-greven.de
- Phone: +49-2571-502-12001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.