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Recombinant Human Bone Morphogenetic Protein-2: A Randomized Trial in Open Tibial Fractures Treated with Reamed Nail Fixation

Aro, Hannu T., MD, PhD1; Govender, Shunmugam, MBBS, MD, FRCS2; Patel, Amratlal D., FRCS3; Hernigou, Philippe, MD4; Perera de Gregorio, Arturo, MD5; Popescu, Gheorghe Ion, MD6; Golden, Jane Davis, MHP7; Christensen, Jared, PhD7; Valentin, Alexandre, MD7

doi: 10.2106/JBJS.I.01763
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Supplementary Content

Background: Recombinant human bone morphogenetic protein-2 (rhBMP-2) improves healing of open tibial fractures treated with unreamed intramedullary nail fixation. We evaluated the use of rhBMP-2 in the treatment of acute open tibial fractures treated with reamed intramedullary nail fixation.

Methods: Patients were randomly assigned (1:1) to receive the standard of care consisting of intramedullary nail fixation and routine soft-tissue management (the SOC group) or the standard of care plus an absorbable collagen sponge implant containing 1.5 mg/mL of rhBMP-2 (total, 12.0 mg) (the rhBMP-2/ACS group). Randomization was stratified by fracture severity. The absorbable collagen sponge was placed over the fracture at wound closure. The primary efficacy end point was the proportion of subjects with a healed fracture as demonstrated by radiographic and clinical assessment thirteen and twenty weeks after definitive wound closure.

Results: Two hundred and seventy-seven patients were randomized and were the subjects of the intent-to-treat analysis. Thirteen percent of the fractures were Gustilo-Anderson Type IIIB. The proportions of patients with fracture-healing were 60% and 48% at week 13 (p = 0.0541) and 68% and 67% at week 20 in the rhBMP-2/ACS and SOC groups, respectively. Twelve percent of the subjects underwent secondary procedures in each group; more invasive procedures (e.g., exchange nailing) accounted for 30% of the procedures in the rhBMP-2/ACS group and 57% in the SOC group (p = 0.1271). Infection was seen in twenty-seven (19%) of the patients in the rhBMP-2/ACS group and fifteen (11%) in the SOC group (p = 0.0645; difference in infection risk = 0.09 [95% confidence interval, 0.0 to 0.17]). The adverse event incidence was otherwise similar between the treatment groups.

Conclusions: The healing of open tibial fractures treated with reamed intramedullary nail fixation was not significantly accelerated by the addition of an absorbable collagen sponge containing rhBMP-2.

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

1Turku University Hospital, Kiinamyllynkatu 10, 20520 Turku, Finland. E-mail address: hannu.aro@utu.fi

2Department of Orthopaedics, University of Kwazulu-Natal, Durban 4013, South Africa

3Department of Orthopaedics, Norfolk and Norwich University Hospital, Colney Lane, Norwich NR4 7UY, United Kingdom

4Service d'Orthopédie et de Traumatologie, Hôpital Henri Mondor, 51, avenue du Maréchal de Lattre de Tassigny, Créteil 94010, France

5S°. de Traumatologia y Cirugia Ortopedica, Hospital Principe de Asturias, ctra. de Meco s/n, Alcalá de Henares (Madrid) 28805, Spain

6Orthopaedics and Trauma Clinic, Emergency Hospital, Calea Floreasca 8 Sector 1, 014461 Bucharest, Romania

7Pfizer, Inc., 35 Cambridge Park Drive, Cambridge, MA 02140

Copyright © 2011 by The Journal of Bone and Joint Surgery, Incorporated
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