Partial Meniscal Replacement with Spongioflex®

Condition(s) studied

Investigational drug(s) / intervention(s)

partial meniscal replacement with Spongioflex®: for 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.

Study summary

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

Primary outcome measure(s)

• To evaluate efficacy of the procedure using the KOOS Score — at 6 weeks, 6 and 12 months (operated patients) and at 2 years and 5 years
  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 — at 6 weeks, 6 and 12 months (operated patients) and at 2 years and 5 years
  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 — at 6 weeks, 6 and 12 months (operated patients) and at 2 years and 5 years
  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

Trial sites (1)

Other trials for the same condition