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Cited by 1,308Bone fractures and treatmentsBone health and osteoporosis researchBone Tissue Engineering Materials

RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 FOR TREATMENT OF OPEN TIBIAL FRACTURES: A PROSPECTIVE, CONTROLLED, RANDOMIZED STUDY OF FOUR HUNDRED AND FIFTY PATIENTS

GOVENDER, SHUNMUGAM, CSIMMA, CRISTINA, GENANT, HARRY K., VALENTIN-OPRAN, ALEXANDRE·2002·The Journal of Bone and Joint Surgery-American Volume
DOI 10.2106/00004623-200212000-00001
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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.

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Authors
GOVENDER, S., CSIMMA, C., GENANT, H. K., & VALENTIN-OPRAN, A.
Affiliations
University of KwaZulu-Natal (ZA)
ORCID
Venue
The Journal of Bone and Joint Surgery-American Volume
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2002-12
Volume
84
Issue
12
Pages
2123-2134
ISSN
0021-9355 (ISSN-L)
DOI
10.2106/00004623-200212000-00001
OpenAlex
W3000473592
Cited by
1,308
References
51
Citations by year
2026: 27 · 2025: 24 · 2024: 20 · 2023: 20 · 2022: 34 · 2021: 39 · 2020: 52 · 2019: 47 · 2018: 55 · 2017: 58 · 2016: 49 · 2015: 74 · 2014: 72 · 2013: 80 · 2012: 72
FWCI
26.38
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Bone and Joint Surgery (publishedVersion)
  • PubMed (publishedVersion)
  • DIAL (Catholic University of Leuven) (submittedVersion)
  • Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
  • UCL Discovery (University College London) (submittedVersion)
Topics
  • Health Sciences › Medicine › Epidemiology › Bone fractures and treatments
  • Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
  • Physical Sciences › Engineering › Biomedical Engineering › Bone Tissue Engineering Materials
Keywords
rhBMP-2, open tibial fractures, tibial shaft fractures, delayed union, nonunion, fracture healing, bone grafting, intramedullary nailing, secondary interventions, hardware failure, infection, bone substitutes, wound closure, Gustilo-Anderson classification
MeSH terms
Adolescent, Adult, Aged, Aged, 80 and over, Female, Fractures, Open, Humans, Male, Middle Aged, Prospective Studies, Recombinant Proteins, Tibial Fractures, Single-Blind Method, Transforming Growth Factor beta, Bone Morphogenetic Proteins, Bone Morphogenetic Protein 2

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