Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss

NCT06376422 · tracked via the Priya Life Science Germany tracker

Sponsor

Sven Behrendt

Phase

Not applicable

Started

2024-04-30

Last updated

2026-10-15

Condition(s) studied

Meniscus Lesion

Investigational drug(s) / intervention(s)

Spongioflex®non-operated

Spongioflex®: partial meniscal replacment during surgery, follow-up visits at the end of hospital stay and after 6 weeks, MRI evaluation and questionnaires after 6, 12, 24 and 60 months.

non-operated: no surgery, MRI evaluation and questionnaires follow-up after 6, 12, 24 and 60 months

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

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

Primary outcome measure(s)

To evaluate efficacy of the procedure — 5 years
Improvement of knee function after surgery compared to the non-operated group and compared to pre-surgery scores.
Improvement of International Knee Documentation Committee (IKDC) score (between 0 and 100, the higher the better) — 5 years
Improvement of IKDC Score after surgery compared to the non-operated group and compared to pre-surgery scores.
Improvement of Knee Injury and Osteoarthritis Outcome Score (KOOS) score (between 0 and 100, the higher the better) — 5 years
Improvement of KOOS score after surgery compared to the non-operated group and compared to pre-surgery scores.
Improvement of Visual Analogue Scale (VAS) Pain Score (between 0 and 10, the lower the better) — 5 years
Improvement of VAS Pain score after surgery compared to the non-operated group and compared to pre-surgery scores.

Trial sites (1)

Facility	City	Region	Status
Privatpraxis für Knie und Schulterchirurgie	Dortmund	Germany	Recruiting

Other trials for the same condition

Partial Meniscal Replacement with Spongioflex® Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06376422 on ClinicalTrials.gov ↗ ← All trials in Germany