Partial Meniscal Replacement with Spongioflex®

Launched by MARIA-JOSEF-HOSPITAL GREVEN · Jan 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of meniscus implant called Spongioflex®, which is designed to help people with partial tears or loss of the meniscus in their knee. The meniscus is a crucial part of the knee that acts as a cushion, and when it is damaged, it can lead to pain and other issues. The goal of this study is to see if this new implant can work better than older materials and help prevent further knee problems, like arthritis or the need for a knee replacement surgery later on. So far, early results look promising.

To be eligible for this trial, participants should be between 18 and 60 years old and have partial loss of the meniscus that causes pain in the knee. They should also be able to undergo the procedure safely. If someone joins the study, they can expect to receive the new implant and be monitored closely to see how well it works. It’s important to note that some people may not qualify due to certain health issues or conditions. Overall, this trial aims to improve the quality of life for those suffering from knee problems related to meniscus injury.

Gender

ALL

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