Partial meniscus replacement using Spongioflex® allograft for knee function improvement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of partial meniscal replacement using Spongioflex® allograft in adults with partial meniscal loss. The study will compare knee function outcomes between patients who undergo the procedure and those who do not, assessing improvements in knee function and the potential to delay total meniscal replacement. Participants will receive the intervention and attend follow-up visits, including MRI assessments, for up to five years post-surgery. The focus is on symptomatic, degenerative meniscus damage and its impact on joint stability and function.

Why it matters

Who can join: the full rules

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 it's running

• Privatpraxis für Knie und Schulterchirurgie
  Dortmund, Germany Recruiting

Study contacts

• Principal investigator: Sven Behrendt, MD — Privatpraxis für Knie- und Schulterchirurgie
• Study coordinator: Sven Behrendt, MD
• Email: praxis@dr-sven-behrendt.de
• Phone: +49231 8626064

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.