OTA 2015: PTH bone-graft substitute vs. cancellous autograft for tibial plateau fractures .
A Novel PTH-Based Bone Graft Substitute Demonstrates Noninferiority to Autograft in a Large Phase IIb Study of Tibial Plateau Fractures
183 patients with a tibial plateau fracture were randomized to receive either a modified form of parathyroid hormone (PTH) in fibrin with hydroxapatite/tricalcium phosphate (HA/TCP) granules, or cancellous bone autograft following open reduction and internal fixation. Patients randomized to receive the bone graft substitute were treated with either a low-concentration (0.4mg/mL) or high-concentration (1.0mg/mL) product. The purpose of this study was to compare the efficacy and safety between interventions. Results at 16 weeks indicated higher radiographic healing rate in the high-concentration group compared to the low-concentration group, and that the healing rate in the high-concentration group was statistically noninferior to that of the cancellous bone autograft group. By 52 weeks, all three groups demonstrated composite healing rates of over 90%.
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