87
Participants
Start Date
April 8, 2024
Primary Completion Date
September 30, 2027
Study Completion Date
December 31, 2027
Adaptos®Ortho Wedge (bone grafting surgery)
After screening and enrollment, subjects will undergo medial knee open wedge high tibial osteotomy (OWHTO) with load bearing locking plate fixation. A synthetic bone graft will be used as a bone void filler in the osteotomy defect. Follow-up visits will be at 6 weeks, 3 months, 6 months, and 12 months.
OWHTO without bone grafting
After screening and enrollment, subjects will undergo medial knee open wedge high tibial osteotomy (OWHTO) with load bearing locking plate fixation, without bone grafting. Follow-up visits will be at 6 weeks, 3 months, 6 months, and 12 months.
chronOS® Wedge (bone grafting surgery)
After screening and enrollment, subjects will undergo medial knee open wedge high tibial osteotomy (OWHTO) with load bearing locking plate fixation. A synthetic bone graft will be used as a bone void filler in the osteotomy defect. Follow-up visits will be at 6 weeks, 3 months, 6 months, and 12 months.
Kanta-Häme Central Hospital, Hämeenlinna
Meilahti Bridge Hospital, Helsinki University Hospital, Helsinki
Pihlajalinna Kelloportti, Tampere
Petz Aladár University Teaching Hospital, Győr
University of Szeged Szent-Györgyi Albert Clinical Center, Szeged
Szent György University Teaching Hospital, Székesfehérvár
Lead Sponsor
Biomendex Oy
INDUSTRY