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 range
18 Years – 60 Years
Sex
ALL
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
. Patients (male and female) with:
. Partial loss of portions of the
. 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 criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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