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.
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
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])
Parallel
Spongioflex®
Procedure/Surgerypartial 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
Other interventionno surgery, MRI evaluation and questionnaires follow-up after 6, 12, 24 and 60 months
To evaluate efficacy of the procedure
Improvement of knee function after surgery compared to the non-operated group and compared to pre-surgery scores.
Improvement of International Knee Documentation Committee (IKDC) score (between 0 and 100, the higher the better)
Improvement of IKDC Score after surgery compared to the non-operated group and compared to pre-surgery scores.
Improvement of Knee Injury and Osteoarthritis Outcome Score (KOOS) score (between 0 and 100, the higher the better)
Improvement of KOOS score after surgery compared to the non-operated group and compared to pre-surgery scores.
Improvement of Visual Analogue Scale (VAS) Pain Score (between 0 and 10, the lower the better)
Improvement of VAS Pain score after surgery compared to the non-operated group and compared to pre-surgery scores.
Safety of the patient (adverse events (AE) and serious adverse events (SAE))
Type, frequency and severity of treatment-related AEs and SAEs
Efficacy of the procedure, progression to osteoarthrosis
How many patients show a progression of osteoarthrosis up to total knee arthroplasty (TKA)?
Menuiscus size
size of meniscus ((mm), depends on location, gender and height of patient), after 6 weeks, 6 and 12 months (for operated patients) and after 2 and 5 years, comparison between the operated and the non-operated group
extrusion of meniscus
extrusion of meniscus (yes/no, no extrusion is better) after 6 weeks, 6 and 12 months (for operated patients) and after 2 and 5 years, comparison between the operated and the non-operated group
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Sven Behrendt
Lead sponsor
Privatpraxis für Knie- und Schulterchirurgie
Sponsor institution
