The Efficacy of rhBMP-2 for Posterolateral Lumbar Fusion in Smokers

Glassman, Steven D.; Dimar, John R.; Burkus, Kenneth; Hardacker, James W.; Pryor, Philip W.; Boden, Scott D.; Carreon, Leah Y.

doi:10.1097/brs.0b013e318074c366

Cited by 128 publications

(64 citation statements)

References 28 publications

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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: 67%

“…Institutional funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript" [12]. Furthermore, the accuracy of industry payment disclosure has significant incongruity.…”

Section: Recommendations Of Bias Classification In Scientific Publicamentioning

confidence: 99%

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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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Section: Introductionmentioning

confidence: 67%

Section: Recommendations Of Bias Classification In Scientific Publicamentioning

confidence: 99%

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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“…15,16 In terms of limitations of the study, we note the small sample size of the groups, making subgroup analysis in accordance with the different diagnoses impossible. In addition, the minimum time of postoperative follow-up considered for inclusion (six months) may be insufficient for the detection of fusion failures.…”

Section: Resultsmentioning

confidence: 99%

Analysis of Interbody Versus Posterolateral Fusion for Lumbar Spondylosis

Mendonça¹,

Filho²,

Astur³

et al. 2015

Coluna/Columna

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Objective: To evaluate and compare radiographic and clinical evaluation of patients undergoing interbody fusion versus posterolateral fusion of the lumbar spine. Methods: Retrospective study of patients diagnosed with lumbar spondylosis that were surgically treated in the period from 2012 to 2014. The results were observed by clinical evaluation by the Visual Analogue Scale (VAS) for low back and leg pain. We evaluated functional results and quality of life through the application of the Oswestry Disability Index (ODI) and the Short Form-36 (SF-36) questionnaires, respectively. The pre and postoperative condition were compared in Group 1 (interbody fusion) and Group 2 (posterolateral fusion), in addition to evaluation of fusion by means of post-operative radiograph. Results: A total of 30 patients of 36 were eligible, 12 in Group 1 and 18 in Group 2. The mean follow-up was 10.1 months. Statistical analysis showed similar scores for back and leg pain VAS, SF-36 function scores and Oswestry between groups with interbody and posterolateral fusion, and compared within these groups regarding the pre-and postoperative condition, and found no statistical significance. The successful fusion was similar in both groups, with 11 of 12 patients in

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“…13,17 Early refinement had begun at the same time, such as in studies of rhBMP-2 for PLF specifically in adult spinal deformities and the effect of smoking on fusion. 16,20 Refinement increased and the total number of refinement studies surpassed the total number of initial studies, reaching PSA in 2007 (Fig. 3).…”

Section: Rhbmp-2 For Posterolateral Fusion-off-label Usementioning

confidence: 99%

Off-label innovation: characterization through a case study of rhBMP-2 for spinal fusion

Schnurman¹,

Smith²,

Kondziolka³

2016

SPI

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OBJECTIVE Off-label therapies are widely used in clinical practice by spinal surgeons. Some patients and practitioners have advocated for increased regulation of their use, and payers have increasingly questioned reimbursment for off-label therapies. In this study, the authors applied a model that quantifies publication data to analyze the developmental process from initial on-label use to off-label innovation, using as an example recombinant human bone morphogenetic protein 2 (rhBMP-2) because of its wide off-label use. METHODS As a case study of off-label innovation, the developmental patterns of rhBMP-2 from FDA-approved use for anterior lumbar interbody fusion to several of its off-label uses, including posterolateral lumbar fusion, anterior cervical discectomy and fusion, and posterior lumbar interbody fusion/transforaminal lumbar interbody fusion, were evaluated using the “progressive scholarly acceptance” (PSA) model. In this model, PSA is used as an end point indicating acceptance of a therapy or procedure by the relevant scientific community and is reached when the total number of peer-reviewed studies devoted to refinement or improvement of a therapy surpasses the total number assessing initial efficacy. Report characteristics, including the number of patients studied and study design, were assessed in addition to the time to and pattern of community acceptance, and results compared with previous developmental study findings. Disclosures and reported conflicts of interest for all articles were reviewed, and these data were also used in the analysis. RESULTS Publication data indicated that the acceptance of rhBMP-2 off-label therapies occurred more rapidly and with less evidence than previously studied on-label therapies. Additionally, the community appeared to respond more robustly (by rapidly changing publication patterns) to reports of adverse events than to new questions of efficacy. CONCLUSIONS The development of off-label therapies, including the influence of investigative methods, regulation, and changing perspectives, can be characterized on the basis of publication patterns. The approach and findings in this report could inform future off-label development of therapies and procedures as well as attempts to regulate off-label use.

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The Efficacy of rhBMP-2 for Posterolateral Lumbar Fusion in Smokers

Abstract: The results of this study suggest that rhBMP-2 may enhance fusion rate in cigarette smokers undergoing single-level instrumented posterolateral lumbar fusion. Despite the improvement in fusion rate with rhBMP-2, clinical outcomes measures were still adversely affected in smokers.

Cited by 128 publications

References 28 publications

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

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

Analysis of Interbody Versus Posterolateral Fusion for Lumbar Spondylosis

Off-label innovation: characterization through a case study of rhBMP-2 for spinal fusion

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