Partial meniscus replacement using Spongioflex® allograft for knee function improvement

Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss, an Investigator-initiated Low Interventional Trial.

This study is testing if using a special graft to replace part of the meniscus can help adults with knee pain feel better and avoid more surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Privatpraxis für Knie- und Schulterchirurgie (Academic / other)
• Locations: 1 site (Dortmund)
• Trial ID: NCT06376422 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 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 advanced cartilage damage, or significant knee instability will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve knee function and delay the need for total meniscal replacement in affected patients.

How similar studies have performed: While similar approaches have been explored, this specific use of Spongioflex® allograft for partial meniscal replacement is relatively novel.

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

Where this trial is running

Dortmund

• 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

Conditions Meniscus Lesion; meniscus deficiency; partial meniscus replacement; Spongioflex®; Allograft; International Knee Documentation Committee Score; Knee Injury and Osteoarthritis Outcome Score; Visuelle Analogskala Score