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A Randomized Controlled Trial Comparing rhBMP-2/Absorbable Collagen Sponge Versus Autograft for the Treatment of Tibia Fractures With Critical Size Defects

 The Major Extremity Trauma Research Consortium (METRC)

doi: 10.1097/BOT.0000000000001492
Original Article

Objectives: To compare radiographic union of tibia fractures with bone defects treated with recombinant bone morphogenetic protein‐2 (rhBMP‐2) with allograft to autogenous iliac crest bone graft (ICBG).

Design: FDA-regulated multicenter randomized trial.

Setting: Sixteen US trauma centers.

Patients/Participants: Thirty patients (18–65 years of age) with Type II, IIIA, or IIIB open tibia fracture and bone defect treated with an intramedullary nail.

Intervention: rhBMP-2 (n = 16) versus ICBG (n = 14).

Main Outcome Measurements: Radiographic union within 52 weeks. Secondary outcomes included clinical healing, patient-reported function, major complications, and treatment cost. Equivalence was evaluated by testing whether a 90% two‐sided confidence interval for the difference in the probability of radiographic union between rhBMP‐2 or ICBG is contained with the interval [220% to +20%]. A post hoc Bayesian analysis, using data from a previous trial, was also conducted.

Results: Twenty-three patients had union data at 52 weeks: 7/12 (58.3%) rhBMP-2 were radiographically united compared with 9/11 (81.8%) ICBG, resulting in a treatment difference of −0.23 (90% CI: −0.55 to 0.10). Patients treated with rhBMP-2 had lower rates of clinical healing at 52 weeks (27% vs. 54%), higher mean Short Musculoskeletal Function Assessment scores (dysfunction: 33.3 vs. 23.7; bother score: 32.8 vs. 21.4) and experienced more complications (5 vs. 3). Mean treatment cost for rhBMP-2 was estimated at $14,155 versus $9086 for ICBG.

Conclusions: These data do not provide sufficient evidence to conclude that ICBG and rhBMP-2 are equivalent regarding radiographic union.

Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Reprints: Lisa K. Cannada, MD, 2nd Floor, Ambulatory Care Center, 655 West 8th St, C126, Jacksonville, FL 32209 (e-mail:

Support for this study came from the Orthopaedic Trauma Association, the Department of Defense (W81XWH0920108), and Medtronic Sofamor Danek USA. This study was registered at (#NCT00853489).

The authors report no conflict of interest.

METRC Corporate Authors are listed in Appendix 1.

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Accepted March 29, 2019

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