rhBMP-2 (Recombinant Human Bone Morphogenetic Protein-2) in real world spine surgery. A phase IV, National, multicentre, retrospective study collecting data from patient medical files in French spinal centres

Vincentelli, Ange François; Szadkowski, Marc; Vardon, Dominique; Litrico, S.; Fuentès, S.; Steib, Jean-Paul; Huec, Jean-Charles Le; Huppert, Jean; Dubois, Gilles; Lenoir, T.; Sailhan, Frédéric; Passuti, N.

doi:10.1016/j.otsr.2019.04.023

Cited by 13 publications

(14 citation statements)

References 12 publications

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“…Over the next several years these issues were investigated extensively through new prospective studies, analysis of large databases, and systematic reviews. The vast majority of the subsequent studies reported complication rates similar to the prior literature and repudiated the assertion that complications had been significantly underreported [16][17][18]. Importantly, numerous cohort and large database studies demonstrated no association between BMP use and increased cancer rate [19,20].…”

Section: Introductionmentioning

confidence: 81%

Changes in Recombinant Human Bone Morphogenetic Protein-2 Use in Posterior Fusion Over the Past Two Decades

Nabizadeh

Glassman

Djurasovic

et al. 2021

Cureus

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BackgroundIn 2011, studies suggested that complications and cancer rates associated with bone morphogenetic protein (BMP) were greater than previously reported. However, later studies reported complication rates similar to prior literature and no increased cancer rate. We evaluated the pattern of clinical utilization of BMP in posteriorly based lumbar fusion by comparing two periods: 2002-2004 and 2017-2019. MethodsPatients who received BMP from 2002-2004 (Early) and 2017-2019 (Late) from a single multi-surgeon institution who had a lumbar fusion were identified. One hundred patients from each cohort were randomly selected. Mean total BMP used at each level and the proportion of BMP placed in the interbody space versus posterolateral gutters were evaluated. ResultsIn the transforaminal lumbar intebody fusion (TLIF) cohort, the total BMP dose in the Late group (6.15 mg) was nearly half of that used in the Early group (12.04 mg, p<0.000). The amount of BMP used in the posterolateral gutters remained similar (Early: 4.01 mg vs Late: 3.38 mg, p=0.222). The amount of BMP used in the interbody space was less in the Late group (2.76 mg) compared to the Early group (8.03 mg, p<0.000). In the posterior spinal fusion (PSF) cohort, the total BMP dose remained similar between the Early (11.96 mg) and the Late groups (10.82 mg, p=0.007). ConclusionChange in the use of BMP in TLIF cases was driven by the complications reported in the literature with no change in outcome. A similar impetus was not seen for PSF.

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Section: Introductionmentioning

confidence: 81%

Changes in Recombinant Human Bone Morphogenetic Protein-2 Use in Posterior Fusion Over the Past Two Decades

Nabizadeh

Glassman

Djurasovic

et al. 2021

Cureus

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“…BMP2 is the most widely used osteoinductive BMP in preclinical testing, and it is a part of an osteoinductive device (Infuse™, Medtronic, Dublin, Ireland), currently approved for anterior lumbar interbody fusion (ALIF), acute tibial fractures, and maxillofacial reconstructions [11][12][13][14][15]. However, BMPs have been used off-label in various spinal indications, including cervical spine fusion, posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), posterolateral spinal fusion (PLF), and thoracolumbar fusions [16,17]. Reported side effects in patients included implant displacement, infection, swelling of the adjacent tissue and dysphagia, formations of seroma, radiculitis and nerve root compression, ectopic bone formation, osteolysis, and retrograde ejaculation [11,12,[16][17][18][19][20][21].…”

Section: Bone Regeneration By Bone Morphogenetic Protein Devicesmentioning

confidence: 99%

“…However, BMPs have been used off-label in various spinal indications, including cervical spine fusion, posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), posterolateral spinal fusion (PLF), and thoracolumbar fusions [16,17]. Reported side effects in patients included implant displacement, infection, swelling of the adjacent tissue and dysphagia, formations of seroma, radiculitis and nerve root compression, ectopic bone formation, osteolysis, and retrograde ejaculation [11,12,[16][17][18][19][20][21]. These side effects eventually resulted from the use of supraphysiological doses as registered BMP2-based devices contain 4-12 mg recombinant protein, while the human body contains only a total of 2 mg of BMPs [22].…”

Section: Bone Regeneration By Bone Morphogenetic Protein Devicesmentioning

confidence: 99%

Bone Morphogenetic Proteins, Carriers, and Animal Models in the Development of Novel Bone Regenerative Therapies

et al. 2021

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Bone morphogenetic proteins (BMPs) possess a unique ability to induce new bone formation. Numerous preclinical studies have been conducted to develop novel, BMP-based osteoinductive devices for the management of segmental bone defects and posterolateral spinal fusion (PLF). In these studies, BMPs were combined with a broad range of carriers (natural and synthetic polymers, inorganic materials, and their combinations) and tested in various models in mice, rats, rabbits, dogs, sheep, and non-human primates. In this review, we summarized bone regeneration strategies and animal models used for the initial, intermediate, and advanced evaluation of promising therapeutical solutions for new bone formation and repair. Moreover, in this review, we discuss basic aspects to be considered when planning animal experiments, including anatomical characteristics of the species used, appropriate BMP dosing, duration of the observation period, and sample size.

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“…There are also various applications of BMPs and TGFβs in clinics with carrier molecules [51,[75][76][77][78][79][80][81][82][83][84]. However, the locally applied supraphysiological BMP-2 doses during surgery is reported to be connected with hematoma formation in soft tissue, increased inflammatory response, bone cysts and infection [85] which also increase the importance of clinical follow-up studies.…”

Section: Clinical Studiesmentioning

confidence: 99%

“…Within this family, BMPs as cytokines with the highest osteogenic properties, are the ones which are studied widely in bone regeneration applications as well as in clinic and within them, rhBMP-2 is reported to be the first BMP that was introduced as a bone graft substitute [20]. After the approval of its use in clinics, the use of rhBMP-2, especially in spine surgeries, increased drastically because its use decreased blood loss and surgical time and increased fusion rates [1,21,81]. However, the increased use of rhBMP-2 also brought the negative side effects depending on the high dose usage are also mentioned in this article previously, since they are already pleiotropic [43], yet these are not the only problems related with BMPs.…”

Section: Perspectivementioning

confidence: 99%

BMP and TGFβ use and release in bone regeneration

et al. 2020

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A fracture that does not unite in nine months is defined as nonunion. Nonunion is common in fragmented fractures and large bone defects where vascularization is impaired. The distal third of the tibia, the scaphoid bone or the talus fractures are furthermore prone to nonunion. Open fractures and spinal fusion cases also need special monitoring for healing. Bone tissue regeneration can be attained by autografts, allografts, xenografts and synthetic materials, however their limited availability and the increased surgical time as well as the donor site morbidity of autograft use, and lower probability of success, increased costs and disease transmission and immunological reaction probability of allografts oblige us to find better solutions and new grafts to overcome the cons. A proper biomaterial for regeneration should be osteoinductive, osteoconductive, biocompatible and mechanically suitable. Cytokine therapy, where growth factors are introduced either exogenously or triggered endogenously, is one of the commonly used method in bone tissue engineering. Transforming growth factor β (TGFβ) superfamily, which can be divided structurally into two groups as bone morphogenetic proteins (BMPs), growth differentiation factors (GDFs) and TGFβ, activin, Nodal branch, Mullerian hormone, are known to be produced by osteoblasts and other bone cells and present already in bone matrix abundantly, to take roles in bone homeostasis. BMP family, as the biggest subfamily of TGFβ superfamily, is also reported to be the most effective growth factors in bone and development, which makes them one of the most popular cytokines used in bone regeneration. Complications depending on the excess use of growth factors, and pleiotropic functions of BMPs are however the main reasons of why they should be approached with care. In this review, the Smad dependent signaling pathways of TGFβ and BMP families and their relations and the applications in preclinical and clinical studies will be briefly summarized.

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rhBMP-2 (Recombinant Human Bone Morphogenetic Protein-2) in real world spine surgery. A phase IV, National, multicentre, retrospective study collecting data from patient medical files in French spinal centres

Cited by 13 publications

References 12 publications

Changes in Recombinant Human Bone Morphogenetic Protein-2 Use in Posterior Fusion Over the Past Two Decades

Changes in Recombinant Human Bone Morphogenetic Protein-2 Use in Posterior Fusion Over the Past Two Decades

Bone Morphogenetic Proteins, Carriers, and Animal Models in the Development of Novel Bone Regenerative Therapies

BMP and TGFβ use and release in bone regeneration

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