Partial meniscus replacement using Spongioflex®

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 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.

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

• 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

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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.