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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
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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: Cannada.lisa@gmail.com).

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 ClinicalTrials.gov (#NCT00853489).

The authors report no conflict of interest.

METRC Corporate Authors are listed in Appendix 1.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jorthotrauma.com).

Accepted March 29, 2019

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