Partial Meniscal Replacement with Spongioflex®

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMaria-Josef-Hospital Greven

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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])

Trial design

Treatments tested in this trial

  • partial meniscal replacement with Spongioflex®

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators