Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures a prospective, controlled, randomized study of four hundred and fifty patients

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dc.contributor.authorGovender S.
dc.contributor.authorCsimma C.
dc.contributor.authorGenant H.K.
dc.contributor.authorValentin-Opran A.
dc.contributor.authorAmit Y.
dc.contributor.authorArbel R.
dc.contributor.authorAro H.
dc.contributor.authorAtar D.
dc.contributor.authorBishay M.
dc.contributor.authorBorner M.G.
dc.contributor.authorChiron P.
dc.contributor.authorChoong P.
dc.contributor.authorCinats J.
dc.contributor.authorCourtenay B.
dc.contributor.authorFeibel R.
dc.contributor.authorGeulette B.
dc.contributor.authorGovender S.
dc.contributor.authorGravel C.
dc.contributor.authorHaas N.
dc.contributor.authorRaschke M.
dc.contributor.authorHammacher E.
dc.contributor.authorVan der Velde D.
dc.contributor.authorHardy P.
dc.contributor.authorHolt M.
dc.contributor.authorJosten C.
dc.contributor.authorKetterl R.L.
dc.contributor.authorLindeque B.
dc.contributor.authorLob G.
dc.contributor.authorMathevon H.
dc.contributor.authorMcCoy G.
dc.contributor.authorMarsh D.
dc.contributor.authorMiller R.
dc.contributor.authorMunting E.
dc.contributor.authorOevre S.
dc.contributor.authorNordsletten L.
dc.contributor.authorPatel A.
dc.contributor.authorPohl A.
dc.contributor.authorRennie W.
dc.contributor.authorReynders P.
dc.contributor.authorRommens P.M.
dc.contributor.authorRondia J.
dc.contributor.authorRossouw W.C.
dc.contributor.authorDaneel P.J.
dc.contributor.authorRuff S.
dc.contributor.authorRuter A.
dc.contributor.authorSantavirtal S.
dc.contributor.authorSchidhauer T.A.
dc.contributor.authorGekle C.
dc.contributor.authorSchnettler R.
dc.contributor.authorSegal D.
dc.contributor.authorSeiler H.
dc.contributor.authorSnowdowne R.B.
dc.contributor.authorStapert J.
dc.contributor.authorTaglang G.
dc.contributor.authorVerdonik R.
dc.contributor.authorVogels L.
dc.contributor.authorWeckbach A.
dc.contributor.authorWentzensen A.
dc.contributor.authorWisriewsk T.
dc.date.accessioned2011-05-15T16:16:52Z
dc.date.available2011-05-15T16:16:52Z
dc.date.issued2002
dc.description.abstractBackground: The treatment of open fractures of the tibial shaft is often complicated by delayed union and non-union. 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.
dc.description.versionArticle
dc.identifier.citationJournal of Bone and Joint Surgery - Series A
dc.identifier.citation84
dc.identifier.citation12
dc.identifier.issn00219355
dc.identifier.urihttp://hdl.handle.net/10019.1/13969
dc.subjectbone morphogenetic protein 2
dc.subjectrecombinant bone morphogenetic protein 2
dc.subjectadolescent
dc.subjectadult
dc.subjectaged
dc.subjectankle pain
dc.subjectarticle
dc.subjectbone radiography
dc.subjectbone transplantation
dc.subjectclinical trial
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdebridement
dc.subjectdisease severity
dc.subjectdrug efficacy
dc.subjectdrug safety
dc.subjectedema
dc.subjectfemale
dc.subjectfracture fixation
dc.subjectfracture healing
dc.subjectfracture nonunion
dc.subjecthuman
dc.subjectimplant
dc.subjectinfection
dc.subjectintramedullary nailing
dc.subjectknee pain
dc.subjectleg pain
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmulticenter study
dc.subjectopen fracture
dc.subjectoutcomes research
dc.subjectpriority journal
dc.subjectprosthesis failure
dc.subjectrandomized controlled trial
dc.subjectsingle blind procedure
dc.subjectsoft tissue injury
dc.subjecttibia
dc.subjecttibia fracture
dc.subjecttreatment failure
dc.subjecttreatment outcome
dc.subjectwound closure
dc.subjectwound healing
dc.subjectwound irrigation
dc.subjectAdolescent
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectBone Morphogenetic Proteins
dc.subjectFemale
dc.subjectFractures, Open
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectProspective Studies
dc.subjectRecombinant Proteins
dc.subjectSingle-Blind Method
dc.subjectTibial Fractures
dc.subjectTransforming Growth Factor beta
dc.titleRecombinant human bone morphogenetic protein-2 for treatment of open tibial fractures a prospective, controlled, randomized study of four hundred and fifty patients
dc.typeArticle
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