Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss
Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss, an Investigator-initiated Low Interventional Trial.
Sven Behrendt
40 participants
Apr 30, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if partial meniscal replacement can prevent or postpone total meniscal replacement, in adult patients (female/male) with partial meniscal loss. The main questions it aims to answer are: * Can partial meniscal replacement improve knee function? * Can partial meniscal replacement prevent/postpone total meniscal replacement/knee prothesis? Researchers will compare the results of the operated group with patients not willing to be operated but with partial meniscal loss to see if the operation improves knee function. Participants will be operated and have to attend follow-up visits with MRI after 6 months up to 5 years after surgery.
Eligibility
Inclusion Criteria7
- Patients (male and female) with:
- Partial loss of portions of the
- lateral meniscus and lateral joint line pain OR
- medial meniscus and medial joint line pain
- sufficient standing of the peripheral rim, so that the procedure can be performed
- Age: 18-60 years
- signed written informed consent to the study and to provide the scientific data in pseudonymized form
Exclusion Criteria17
- 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.
- Axial deviation (\>2° varus or valgus)
- realignment osteotomy not performed within 12 weeks
- advanced cartilage damage (grade III according to ICRS) and osteoarthrosis in the affected compartment (grade III according to Kellgren and Lawrence \[33\])
- Extension deficit of more than 3° compared to the opposite side or a knee flexion of less than 125°
- inflammatory arthritis or synovitis on the treated knee
- BMI greater than 30 kg/m²
- \<18 years, \>60 years
- Chronic pain patients
- only for patients who will be operated:
- with increased anaesthesiologic risk, e.g., with known or predicted difficult airway
- with increased risk of bleeding
- with increased risk of infection
- with necrotic, infected, or poorly perfused host sides
- history of allergic reactions
- acute hypersensitivity reactions to the IMP or any of its excipients
- pregnant woman
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Interventions
partial meniscal replacment during surgery, follow-up visits at the end of hospital stay and after 6 weeks, MRI evaluation and questionnaires after 6, 12, 24 and 60 months.
no surgery, MRI evaluation and questionnaires follow-up after 6, 12, 24 and 60 months
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06376422