Prospective, randomized, partially blinded multicenter RCT at 17 U.S. centers (1992–1996). Compared rhOP-1/BMP-7 in a type I collagen carrier versus fresh bone autograft — both with intramedullary fixation — for established tibial nonunions. Primary endpoint was clinical success at 9 months, with follow-up extended to 24 months.
Autograft has long been the gold standard for tibial nonunion, but its costs are real: a second operative site, universal donor pain, and — as this trial revealed. A 21% osteomyelitis rate at the fracture site.
When a patient with tibial nonunion has limited graft availability, prior failed autograft, or significant donor site risk, BMP-7 with intramedullary fixation is a validated alternative with equivalent union rates.
The baseline imbalance matters here: the OP-1 group had more atrophic nonunions (41% vs. 25%) and more smokers, yet still matched autograft outcomes. Suggesting BMP-7 may be particularly valuable in the biologicallychallenging cases.
This trial directly enabled FDA approval of BMP-7 for tibial nonunions and established the framework. Biologic agent plus stable fixation plus healthy host bed. That governs all subsequent BMP clinical use.
Prospective, randomized, partially blinded multicenter RCT at 17 U.S. centers (1992–1996). Compared rhOP-1/BMP-7 in a type I collagen carrier versus fresh bone autograft — both with intramedullary fixation — for established tibial nonunions. Primary endpoint was clinical success at 9 months, with follow-up extended to 24 months.
Autograft has long been the gold standard for tibial nonunion, but its costs are real: a second operative site, universal donor pain, and — as this trial revealed. A 21% osteomyelitis rate at the fracture site.
When a patient with tibial nonunion has limited graft availability, prior failed autograft, or significant donor site risk, BMP-7 with intramedullary fixation is a validated alternative with equivalent union rates.
The baseline imbalance matters here: the OP-1 group had more atrophic nonunions (41% vs. 25%) and more smokers, yet still matched autograft outcomes. Suggesting BMP-7 may be particularly valuable in the biologicallychallenging cases.
This trial directly enabled FDA approval of BMP-7 for tibial nonunions and established the framework. Biologic agent plus stable fixation plus healthy host bed. That governs all subsequent BMP clinical use.