Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Menisc… (NCT06376422) | Clinical Trial Compass
RecruitingNot Applicable
Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss
Germany40 participantsStarted 2024-04-30
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Patients (male and female) with:
âś“. Partial loss of portions of the
âś“. sufficient standing of the peripheral rim, so that the procedure can be performed
âś“. Age: 18-60 years
âś“. signed written informed consent to the study and to provide the scientific data in pseudonymized form
Exclusion criteria
âś•. 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)
âś•. realignment osteotomy not performed within 12 weeks
âś•. advanced cartilage damage (grade III according to ICRS) and osteoarthrosis in the affected compartment (grade III according to Kellgren and Lawrence \[33\])
âś•
What they're measuring
1
To evaluate efficacy of the procedure
Timeframe: 5 years
2
Improvement of International Knee Documentation Committee (IKDC) score (between 0 and 100, the higher the better)
Timeframe: 5 years
3
Improvement of Knee Injury and Osteoarthritis Outcome Score (KOOS) score (between 0 and 100, the higher the better)
Timeframe: 5 years
4
Improvement of Visual Analogue Scale (VAS) Pain Score (between 0 and 10, the lower the better)