The purpose of this investigator-initiated trial is to evaluate whether the novel graft can prevent/reduce the disadvantages of the previously used replacement materials and shows better results than the group of patients, which were not operated. Since there is currently no alternative made of biological material to this product, this investigator-initiated trial is of great medical and economic importance. The otherwise following arthrosis or knee prosthesis implantation (TKA ) could be prevented or at least postponed. Initial clinical results are promising.
An important and sensitive parameter for assessing the postoperative function of the meniscus is the MRI image. Genovese et al. 2007 were able to show in a categorization/classification which magnetic resonance image can be expected in the case of successful incorporation. Several studies have shown that the known clinical knee scores (Lysholm, IKDC, KOOS, VAS pain) improve significantly after successful ingrowth of the meniscus implant.
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
partial meniscal replacement with Spongioflex®
Procedure/Surgeryfor any surgical procedure, the patient receives an antibiotic shot NIMP) just before surgery. The patient will be arthroscopically treated via the arthroscopic portal with implantation of a demineralized bone block (IMP: Spongioflex ®, appropriate size (DIZG gGmbH, Berlin, Germany)) as a partial meniscus substitute. The block will be adapted to the defect size and secured with 2-4 inside-out sutures (Etibond 0, Ethicon, Somerville, NJ). No dosing, the IMP has no systemic effect. The surgery (Intervention) will last between 60-90 minutes. The hospital stay is between 2-3 days after surgery. Follow-up visits: at the end of the hospital stay, after 6 weeks, after 6, 12 and 24 months and after 5 years for the operated group.
To evaluate efficacy of the procedure using the KOOS Score
Improvement of KOOS 2 and 5 years after surgery compared to scores of the non-operated group and compared to pre-surgery scores
To evaluate efficacy of the procedure using the IKDC
Improvement of IKDC 2 and 5 years after surgery compared to scores of the non-operated group and compared to pre-surgery scores
To evaluate efficacy of the procedure using the VAS pain Score
Improvement of VAS pain Score 2 and 5 years after surgery compared to scores of the non-operated group and compared to pre-surgery scores
Safety of the patient using the number of adverse events an serious adverse events
Type, frequency and severity of treatment-related AEs and SAEs
Efficacy of the procedure to prevent/prolonge progression to TKA
How many patients show a progression of osteoarthrosis up to TKA?
MRI evaluation using outerbridge graduation
Outerbridge graduation at 6 weeks, 6 and 12 months (for operated patients) and at 2 and 5 years, comparison between the operated and the non-operated group
MRI evaluation for size of meniscus
size of meniscus, at 6 weeks, 6 and 12 months (for operated patients) and at 2 and 5 years, comparison between the operated and the non-operated group
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