Partial Meniscal Replacement with Spongioflex®

PHASE4RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 5, 2024

Primary Completion Date

November 5, 2029

Study Completion Date

November 5, 2031

Conditions
Partial Meniscal LossLateral Meniscus Partial LossMedial Meniscal Partial LossMeniscus LesionMeniscal InjuriesMeniscal Tear
Interventions
PROCEDURE

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.

Trial Locations (1)

48268

RECRUITING

Maria-Josef-Hospital Greven GmbH, Greven

All Listed Sponsors
lead

Maria-Josef-Hospital Greven

OTHER