title: No effect of Osteoset, a bone graft substitute, on bone healing in humans: a prospective randomized double-blind study.
abstract: We studied the effects of a newly marketed bone substitute, Osteoset, on bone healing in a tibial defect in humans. 20 patients undergoing an ACL (anterior cruciate ligament) reconstruction with bone-patella tendon-bone graft were block-randomized into 2 groups of 10 each. In the treatment group, the tibial defect was filled manually with Osteoset pellets, in the control group the defect was left empty. CTs of the defect were taken on the first day after the operation, 6 weeks, 3 and 6 months postoperatively. We found about the same amount of bone in the defect in the Osteoset and control groups after 6 weeks, 3, and 6 months. In the control group, but not in the Osteoset group, the bone volume increased from 6 weeks to 3 months. The Osteoset pellets were almost resorbed after 6 weeks.
authors.affiliation: Department of Orthopaedics, Randers County Hospital, Denmark. juozasp@dadlnet.dk
authors.forename: Juozas
authors.initials: J
authors.lastname: Petruskevicius
authors.forename: Strange
authors.initials: S
authors.lastname: Nielsen
authors.forename: Søren
authors.initials: S
authors.lastname: Kaalund
authors.forename: Preben R
authors.initials: PR
authors.lastname: Knudsen
authors.forename: Søren
authors.initials: S
authors.lastname: Overgaard
mesh_terms: D000328:Adult; D016118:Anterior Cruciate Ligament / Q000503:physiopathology / Q000601:surgery*; D000070598:Anterior Cruciate Ligament Injuries; D018786:Bone Substitutes / Q000494:pharmacology*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010012:Osteogenesis / Q000187:drug effects* / Q000502:physiology; D010329:Patella / Q000187:drug effects / Q000503:physiopathology / Q000601:surgery; D011446:Prospective Studies; D013710:Tendons / Q000187:drug effects / Q000503:physiopathology / Q000637:transplantation; D013977:Tibia / Q000187:drug effects* / Q000503:physiopathology / Q000601:surgery*; D013997:Time Factors; D014945:Wound Healing / Q000187:drug effects* / Q000502:physiology
chemical_list: D018786:Bone Substitutes