Recombinant Human Bone Morphogenetic Protein-2 on an Absorbable Collagen Sponge with an Osteoconductive Bulking Agent in Posterolateral Arthrodesis with Instrumentation

Dawson, Edgar G.; Bae, Hyun; Burkus, J. Kenneth; Stambough, Jeffery L.; Glassman, Steven D.

doi:10.2106/jbjs.g.01157

Cited by 149 publications

(80 citation statements)

References 22 publications

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“…Ceramic carriers have been shown to provide compression-resistant structure in bone healing, both as a bulking agent and a successful bone graft extender in lumbar posterolateral spine fusion. 9,43 Pre-clinical studies have also suggested that because of its favorable binding properties to osteoinductive growth factors such as rhBMP-2, the dose required to achieve successful bony fusion is effectively reduced. 44,45 To this end, recent studies have demonstrated that a 10-15% hydroxyapatite composition in a ceramic carrier is ideal for stem cell adhesion and osteoblastic differentiation.…”

Section: Discussionmentioning

confidence: 99%

Nanocomposite therapy as a more efficacious and less inflammatory alternative to bone morphogenetic protein‐2 in a rodent arthrodesis model

Hsu¹,

Polavarapu²,

Riaz³

et al. 2011

Journal Orthopaedic Research

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The use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spine fusion has led to concerns regarding a potential accompanying inflammatory response. This study evaluates a combination therapy (TrioMatrix 1 ; Pioneer Surgical, Inc., Marquette, MI) comprised of a demineralized bone matrix (DBM), hydroxyapatite, and a nanofiber-based collagen scaffold in a rodent spine fusion model. Thirty-six athymic rats that underwent a posterolateral intertransverse spinal fusion were randomly assigned to 1 of 5 treatment groups: absorbable collagen sponge alone (ACS, negative control), 10 mg rhBMP-2 on ACS (positive control), TrioMatrix 1 , Grafton 1 (Osteotech, Inc., Eatontown, NJ), and DBX 1 (Synthes, Inc., West Chester, PA). Both TrioMatrix 1 and rhBMP-2-treated animals demonstrated 100% fusion rates as graded by manual palpation scores 8 weeks after implantation. This rate was significantly greater than those of the ACS, Grafton 1 , and DBX 1 groups. Notably, the use of TrioMatrix 1 as evaluated by microCT quantification led to a greater fusion mass volume when compared to all other groups, including the rhBMP-2 group. T2-weighted axial MRI images of the fusion bed demonstrated a significant host response associated with a large fluid collection with the use of rhBMP-2; this response was significantly reduced with the use of TrioMatrix 1 . Our results therefore demonstrate that a nanocomposite therapy represents a promising, cost-effective bone graft substitute that could be useful in spine fusions where BMP-2 is contraindicated.

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Section: Discussionmentioning

confidence: 99%

Nanocomposite therapy as a more efficacious and less inflammatory alternative to bone morphogenetic protein‐2 in a rodent arthrodesis model

Hsu¹,

Polavarapu²,

Riaz³

et al. 2011

Journal Orthopaedic Research

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“…Their study indicates a significant difference in operative nonunion rates (0%) versus radiographic nonunion rates (10.3%). As we previously described, the studies of Dawson et al 12 and Singh et al 38 found that a radiographic measure of nonunions may be too stringent and not necessarily represent normal clinical practices in which CT scans are routinely obtained and patients are followed for 2 years. Again, we believe operative nonunion rates are useful and clinically relevant and can be used to compare BMP to non-BMP patients.…”

Section: Discussionmentioning

confidence: 99%

“…1,18,33 Many of these studies defined fusion rates based solely on radiographic studies. However, several studies 9,12,16,24,38 have shown that radiographic nonunions do not necessarily translate into symptomatic nonunions. Dawson et al 12 and Singh et al 38 noted the radiographic definition of "nonunion" may have been too stringent in many studies presented in the literature and may not be representative of normal clinical practices.…”

mentioning

confidence: 99%

“…However, several studies 9,12,16,24,38 have shown that radiographic nonunions do not necessarily translate into symptomatic nonunions. Dawson et al 12 and Singh et al 38 noted the radiographic definition of "nonunion" may have been too stringent in many studies presented in the literature and may not be representative of normal clinical practices. As an alternative, we believe reoperation rates for symptomatic nonunions is one measure that combines clinical and radiographic findings and is an important outcome measure for patients and health care payers, and would be worthy of adding to the literature.…”

mentioning

confidence: 99%

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Reoperation rates for symptomatic nonunions in posterior cervical (subaxial) fusions with and without bone morphogenetic protein in a cohort of 1158 patients

Guppy

Harris

Chen

et al. 2016

SPI

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OBJECTIVE Bone morphogenetic protein (BMP) was first approved in 2002 for use in single-level anterior lumbar fusions as an alternative to iliac crest grafts. Subsequent studies have concluded that BMP provides superior fusions rates and therefore reduces reoperations for nonunions. The purpose of this study was to determine the reoperation rates for symptomatic nonunions in posterior cervical (subaxial) spinal fusions with and without the use of BMP and to determine if the nonunion rates are statistically significantly different between the two groups. METHODS Between January 2009 and September 2013, the authors identified 1158 posterior cervical spinal fusion cases in the subaxial spine (C2–7) from a large spine registry (Kaiser Permanente). Patient characteristics, diagnoses, operative times, lengths of stay, and reoperations were extracted from the registry. Reoperations for symptomatic nonunions were adjudicated via chart review. Logistic regression was conducted to produce estimates of odds ratios (OR) and 95% confidence intervals (CIs). Kaplan-Meier curves for the non-BMP and BMP groups were generated and compared using the log-rank test. RESULTS In this cohort there were 1158 patients (19.3% with BMP) with a median follow up of 1.7 years (interquartile range [IQR] 0.7–2.9 years) and median duration to operative nonunion of 0.63 years (IQR 0.44–1.57 years). Kaplan-Meier curves showed no significant difference in reoperation rates for nonunions using the log-rank test (p = 0.179). In a subset of patients with more than 1 year of follow-up, 788 patients were identified (22.5% with BMP) with a median follow-up duration of 2.5 years (IQR 1.7–3.4 years) and a median time to operative nonunion of 0.73 years (IQR 0.44–1.57 years). There was no statistically significant difference in the symptomatic operative nonunion rates for posterior cervical (subaxial) fusions with BMP compared with non-BMP (1.1% vs 0.7%; crude OR 1.73, 95% CI 0.32–9.55, p = 0.527) for more than 1 year of follow-up. CONCLUSIONS This study presents the largest series of patients using BMP in posterior cervical (subaxial) spinal fusions. Reoperation rates for symptomatic nonunions with more than 1 year of follow-up were found to be 1.1% with BMP and 0.7% without BMP. There was no significant difference in the reoperation rates for symptomatic nonunions with or without BMP.

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“…The authors of the original industry-sponsored or industry-associated studies of rhBMP-2 all reported the efficacy in applications including both anterior and posterior cervical and lumbar fusion surgery [3][4][5][6][7][8][9][10][11][12][13][14]. Additionally, the authors of these studies stated similar safety profiles with no adverse effects or complications attributable to rhBMP-2 in any study.…”

Section: Introductionmentioning

confidence: 98%

Lessons from the infuse trials: do we need a classification of bias in scientific publications and editorials?

Hashmi

Noureldin

Khan

2014

Curr Rev Musculoskelet Med

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The original 13 Food and Drug Administration industry-sponsored recombinant human bone morphogenetic protein-2 (rhBMP-2) trials investigating its use in spinal fusion all reported no associated adverse events. However, subsequent series of studies began reporting complication rates that were much higher than those that were initially published. Critical analysis of the original rhBMP-2 industryassociated data found systematic alignment favoring positive outcomes with no proven clinical advantage over bone graft. The sources of potential bias leading to inaccurate reporting of original rhBMP-2 efficacy and safety profile include flawed study design, methodological technique, data reporting and analysis, and significant financial conflict of interest. As such, to ensure the integrity of the scientific literature, further measures should be taken by researchers, surgeons, authors, journal editors and reviewers to assess for potential sources of bias.

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Recombinant Human Bone Morphogenetic Protein-2 on an Absorbable Collagen Sponge with an Osteoconductive Bulking Agent in Posterolateral Arthrodesis with Instrumentation

Cited by 149 publications

References 22 publications

Nanocomposite therapy as a more efficacious and less inflammatory alternative to bone morphogenetic protein‐2 in a rodent arthrodesis model

Nanocomposite therapy as a more efficacious and less inflammatory alternative to bone morphogenetic protein‐2 in a rodent arthrodesis model

Reoperation rates for symptomatic nonunions in posterior cervical (subaxial) fusions with and without bone morphogenetic protein in a cohort of 1158 patients

Lessons from the infuse trials: do we need a classification of bias in scientific publications and editorials?

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