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

Launched by PRIVATPRAXIS FÜR KNIE- UND SCHULTERCHIRURGIE · Apr 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of surgery called partial meniscal replacement, which involves using a special graft to replace part of the meniscus in the knee. The meniscus is a crucial cartilage that helps cushion and stabilize the knee joint. Researchers want to find out if this procedure can help improve knee function and whether it can delay the need for more extensive surgeries, like a total knee replacement, in adults who have lost part of their meniscus. Participants will be compared to others who have not had surgery to see how well the treatment works.

To join the trial, participants should be between 18 and 60 years old and have partial loss of the meniscus along with knee pain. They must also be able to provide consent and meet other specific health criteria. If enrolled, participants will have the surgery and will need to attend follow-up visits, including MRI scans, for up to five years to monitor their progress. This trial is currently looking for new participants, and it aims to provide valuable information about this treatment option for people with meniscus injuries.

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