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

Aro, Hannu T.; Govender, S.; Patel, A.D.; Hernigou, Philippe; Gregorio, Arturo Perera de; Popescu, Ionel Cătălin; Golden, Jane Davis; Christensen, Jared; Valentin, A.

doi:10.2106/jbjs.i.01763

Cited by 155 publications

(102 citation statements)

References 19 publications

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“…Recombinant human BMP-2 protein has been clinically used to enhance bone healing 18,27,28 Although our study did not find a significant difference in TGF-β1 or BMP-2 levels between normal union and nonunion groups which is consistent with previously reported findings, however we found a delayed maximal peak for both TGF-β1 and BMP-2 proteins in nonunion patients as compared to the normal union patients. The peak plasma value of TGF-β1 at 2-week may be explained by the fact that TGF-β1 is released from the granules of platelets during the clotting process soon after trauma 31 .…”

Section: Discussionsupporting

confidence: 92%

“…Also, the expressions of type IIB relative to type IIA procollagens and alpha 10 relative to alpha 11 integrin subunits were found to be good markers of chondrocytes differentiation state 16 . BMP-2 deficiency has been implicated in the delayed union or nonunion and recombinant BMP-2 and BMP-7 have been clinically used in the treatment of delayed union or nonunion 15,17,18 . In addition a possibility of involvement of a BMP-related genetic predisposition in impaired fracture healing has been reported 19 .…”

Section: Introductionmentioning

confidence: 99%

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Delayed Expression of Circulating TGF-β1 and BMP-2 Levels in Human Nonunion Long Bone Fracture Healing

et al. 2017

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Background:The healing process of bone fracture requires a well-controlled multistage and sequential order beginning immediately after the injury. However, complications leading to nonunion exist, creating serious problems and costs for patients. Transforming growth factor-beta 1 (TGF-β1) and bone morphogenic protein 2 (BMP-2) are two major growth factors involved in human bone fracture healing by promoting various stages of bone ossification. In this study, we aimed to determine the role of these factors during the fracture healing of human long bones and assess their impacts on nonunion condition. Materials and Methods:We performed a comprehensive analysis of plasma TGF-β1 and BMP-2 levels in blood samples from 10 patients with proved nonunion and 10 matched patients with normal union following a predetermined time schedule. The concentrations of TGF-β1 and BMP-2 were measured at each time point using a solid-phase ELISA.Results: TGF-β1 and BMP-2 levels were detectable in all patients. For all patients, a maximal peak for TGF-β1 was found at 3-week. In normal union group, TGF-β1 showed a maximal peak at 2-week while nonunion group had a delayed maximal peak at 3-week. Plasma levels of BMP-2 for all patients and for normal union group reached a maximal peak at 1-week, but nonunion group showed a delayed maximal peak at 2-week. In general, plasma TGF-β1 or BMP-2 level was not significantly different between normal union and nonunion groups. Conclusion:The expression levels of TGF-β1 and BMP-2 appeared to be delayed in nonunion patients which could play an important role in developing an early marker of fracture union condition and facilitate improved patient's management. (J Nippon Med Sch 2017; 84: 12 18)

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Section: Discussionsupporting

confidence: 92%

Section: Introductionmentioning

confidence: 99%

Delayed Expression of Circulating TGF-β1 and BMP-2 Levels in Human Nonunion Long Bone Fracture Healing

et al. 2017

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“…Govender et al [8] evaluated rhBMP-2 in patients with open tibial shaft fractures and found a large reduction in the need for secondary procedures. Aro et al [1] conducted a subsequent RCT in a similar population and found no difference in secondary procedures. Aro et al [1] postulated that the difference was attributable to the type of nailing: the first trial included a majority of patients treated with unreamed nailing whereas the subsequent trial was restricted to patients with reamed nailing.…”

Section: Are the Results Of Individual Studies In The Direct Comparismentioning

confidence: 99%

“…Aro et al [1] conducted a subsequent RCT in a similar population and found no difference in secondary procedures. Aro et al [1] postulated that the difference was attributable to the type of nailing: the first trial included a majority of patients treated with unreamed nailing whereas the subsequent trial was restricted to patients with reamed nailing. In the trial by Govender et al [8], benefit was restricted to patients who had undergone unreamed nailing and the subsequent trial was conducted to clarify the effect in patients undergoing reamed nailing (and it confirmed the lack of benefit seen in in the initial trial).…”

Section: Are the Results Of Individual Studies In The Direct Comparismentioning

confidence: 99%

Network Meta-analysis: Users’ Guide for Surgeons: Part II - Certainty

Chaudhry

Foote

Guyatt

et al. 2015

Clinical Orthopaedics &Amp; Related Research

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In the previous article (Network Meta-analysis: Users' Guide for Surgeons-Part I, Credibility), we presented an approach to evaluating the credibility or methodologic rigor of network meta-analyses (NMA), an innovative approach to simultaneously addressing the relative effectiveness of three or more treatment options for a given medical condition or disease state. In the second part of the Users' Guide for Surgeons, we discuss and demonstrate the application of criteria for determining the certainty in effect sizes and directions associated with a given treatment option through an example pertinent to clinical orthopaedics.

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“…BMPs are thought to initiate fracture healing, but they have obvious side effects such as local swelling, pain, and increased risk of wound infections (Aro et al 2011, Carragee et al 2011). Studies sponsored by industry have obviously not reported the adverse effects associated with the administration of BMPs in spinal fusion (Carragee et al 2011).…”

mentioning

confidence: 99%

PTH 1-34 (teriparatide) may not improve healing in proximal humerus fractures

Johansson

2015

Acta Orthopaedica

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Background and purposeThere is solid evidence from animal experiments that parathyroid hormone (PTH) improves fracture healing. So far, only 3 papers on PTH and fracture repair in humans have been published. They suggest that PTH may enhance fracture healing, but the results do not appear to justify specific clinical recommendations. This study was carried out to determine whether teriparatide enhances fracture healing of proximal humerus fractures.Patients and methods40 post-menopausal women with a proximal humerus fracture were randomized to either daily injections with 20 µg teriparatide (PTH 1-34 (Forteo)) for 4 weeks or control treatment. At randomization, the patients were asked to assess how their pain at rest and during activity (visual analog scale (VAS)) and also function (DASH score) had been prior to the fracture. At 7 weeks and again at 3 months, their current state was assessed and the tests were repeated, including radiographs. 2 radiologists performed a blind qualitative scoring of the callus at 7 weeks. Callus formation was arbitrarily classified as ”normal” or “better”.Results39 patients completed the follow-up. The radiographic assessment showed a correct correlation, “better” in the teriparatide group and “normal” in the control group, in 21 of the 39 cases. There were no statistically significant differences in pain, in use of strong analgesics, or in function between the groups at the follow-up examinations.InterpretationThere were no radiographic signs of enhanced healing or improved clinical results in the group treated with teriparatide

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

Abstract: 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.

Cited by 155 publications

References 19 publications

Delayed Expression of Circulating TGF-β1 and BMP-2 Levels in Human Nonunion Long Bone Fracture Healing

Delayed Expression of Circulating TGF-β1 and BMP-2 Levels in Human Nonunion Long Bone Fracture Healing

Network Meta-analysis: Users’ Guide for Surgeons: Part II - Certainty

PTH 1-34 (teriparatide) may not improve healing in proximal humerus fractures

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