Title: Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: a prospective, controlled, randomized study of four hundred and fifty patients
Authors: Govender, Shunmugam ×
Csimma, Cristina
Genant, Harry K
Valentin-Opran, Alexandre
Amit, Yehuda
Arbel, Ron
Aro, Hannu
Atar, Dan
Bishay, Michael
Börner, Martin G
Chiron, Philippe
Choong, Peter
Cinats, John
Courtenay, Brett
Feibel, Robert
Geulette, Bernard
Gravel, Charles
Haas, Norbert
Raschke, M
Hammacher, Eric
van der Velde, D
Hardy, Philippe
Holt, Michael
Josten, Christof
Ketterl, Rupert Ludwig
Lindeque, Bennie
Lob, Günter
Mathevon, Henry
McCoy, Gerald
Marsh, D
Miller, Russell
Munting, Everard
Oevre, Stein
Nordsletten, L
Patel, Amratlal
Pohl, Anthony
Rennie, William
Reynders-Frederix, Peter
Rommens, Pol Maria
Rondia, Jean
Rossouw, Willem C
Daneel, P J
Ruff, Stephen
Rüter, Axel
Santavirta, Seppo
Schildhauer, Thomas A
Gekle, C
Schnettler, Reinhard
Segal, David
Seiler, Hanns
Snowdowne, Robert B
Stapert, Jouwert
Taglang, Gilbert
Verdonk, Rene
Vogels, Lucas
Weckbach, Arnulf
Wentzensen, Andreas
Wisniewski, Tadeusz #
Issue Date: 2-Dec-2002
Series Title: Journal of Bone and Joint Surgery. American volume vol:84-A issue:12 pages:2123-34
Abstract: BACKGROUND: The treatment of open fractures of the tibial shaft is often complicated by delayed union and nonunion. The objective of this study was to evaluate the safety and efficacy of the use of recombinant human bone morphogenetic protein-2 (rhBMP-2; dibotermin alfa) to accelerate healing of open tibial shaft fractures and to reduce the need for secondary intervention. METHODS: In a prospective, randomized, controlled, single-blind study, 450 patients with an open tibial fracture were randomized to receive either the standard of care (intramedullary nail fixation and routine soft-tissue management [the control group]), the standard of care and an implant containing 0.75 mg/mL of rhBMP-2 (total dose of 6 mg), or the standard of care and an implant containing 1.50 mg/mL of rhBMP-2 (total dose of 12 mg). The rhBMP-2 implant (rhBMP-2 applied to an absorbable collagen sponge) was placed over the fracture at the time of definitive wound closure. Randomization was stratified by the severity of the open wound. The primary outcome measure was the proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve months postoperatively. RESULTS: Four hundred and twenty-one (94%) of the patients were available for the twelve-month follow-up. The 1.50-mg/mL rhBMP-2 group had a 44% reduction in the risk of failure (i.e., secondary intervention because of delayed union; relative risk = 0.56; 95% confidence interval = 0.40 to 0.78; pairwise p = 0.0005), significantly fewer invasive interventions (e.g., bone-grafting and nail exchange; p = 0.0264), and significantly faster fracture-healing (p = 0.0022) than did the control patients. Significantly more patients treated with 1.50 mg/mL of rhBMP-2 had healing of the fracture at the postoperative visits from ten weeks through twelve months (p = 0.0008). Compared with the control patients, those treated with 1.50 mg/mL of rhBMP-2 also had significantly fewer hardware failures (p = 0.0174), fewer infections (in association with Gustilo-Anderson type-III injuries; p = 0.0219), and faster wound-healing (83% compared with 65% had wound-healing at six weeks; p =0.0010). CONCLUSIONS: The rhBMP-2 implant was safe and, when 1.50 mg/mL was used, significantly superior to the standard of care in reducing the frequency of secondary interventions and the overall invasiveness of the procedures, accelerating fracture and wound-healing, and reducing the infection rate in patients with an open fracture of the tibia.
ISSN: 0021-9355
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Traumatology Section (-)
× corresponding author
# (joint) last author

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