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Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss
Sponsor: Sven Behrendt
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.
Official title: Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss, an Investigator-initiated Low Interventional Trial.
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-04-30
Completion Date
2031-04-30
Last Updated
2025-08-06
Healthy Volunteers
No
Conditions
Interventions
Spongioflex®
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.
non-operated
no surgery, MRI evaluation and questionnaires follow-up after 6, 12, 24 and 60 months
Locations (1)
Privatpraxis für Knie und Schulterchirurgie
Dortmund, Germany