Long-Segment Fusion for Adult Spinal Deformity Correction Using Low-Dose Recombinant Human Bone Morphogenetic Protein-2

Schmitt, Paul J.; Kelleher, John; Ailon, Tamir; Heller, Joshua; Kasliwal, Manish K.; Shaffrey, Christopher I.; Smith, Justin S.

doi:10.1227/neu.0000000000001194

Cited by 19 publications

(14 citation statements)

References 57 publications

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“…Bone morphogenetic proteins (BMPs) are some of the most prominent and most widely studied osteogenic molecules with a strong effect on the osteogenic differentiation and proliferation of stem cells. Human recombinant BMP‐2 received approval from the Food and Drug Administration in 2002 for clinical applications and has been frequently used for the treatment of complicated fractures, non‐unions and spinal fusion procedures, as well as to regenerate maxillofacial bone . Despite its widespread clinical use, it became obvious that delivery of BMP‐2 needs optimization as a result of its short biological half‐life .…”

Section: Introductionmentioning

confidence: 99%

Bone morphogenetic protein‐2 is a stronger inducer of osteogenesis within muscle tissue than heterodimeric bone morphogenetic protein‐2/6 and ‐2/7: Implications for expedited gene‐enhanced bone repair

Betz

Ren

Messmer

et al. 2018

The Journal of Gene Medicine

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Section: Introductionmentioning

confidence: 99%

Bone morphogenetic protein‐2 is a stronger inducer of osteogenesis within muscle tissue than heterodimeric bone morphogenetic protein‐2/6 and ‐2/7: Implications for expedited gene‐enhanced bone repair

Betz

Ren

Messmer

et al. 2018

The Journal of Gene Medicine

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“…It is possible that the ever-increasing downward pressures on healthcare cost may have constrained the growth in rhBMP-2 use, despite growing evidence of its effectiveness in the field of ASD. 21,[33][34][35] This stabilization of use could also be related to concerns about the potential increased risk of malignancy as the FDA application for Amplify (Amplify Surgical, Inc.), a posterolateral graft implant with a dose of 40 mg/level of rhBMP-2, was rejected in 2011 for this specific reason. 8,36 In 2013, the first two meta-analyses performed using data that were issued from the Yale University Open Data Access project reported a possibly higher risk of cancer in patients treated with rhBMP-2 and the possibility that this risk could be dose-dependent (10 of the 17 cancer cases were in the highest-dose arm of the trial).…”

Section: Discussionmentioning

confidence: 99%

Use of rhBMP-2 for adult spinal deformity surgery: patterns of usage and changes over the past decade

Bannwarth¹,

Smith

Bess³

et al. 2021

Neurosurgical Focus

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OBJECTIVE Recombinant human bone morphogenetic protein–2 (rhBMP-2) has been shown to increase fusion rates; however, cost, limited FDA approval, and possible complications impact its use. Decisions regarding rhBMP-2 use and changes over time have not been well defined. In this study, the authors aimed to assess changes in rhBMP-2 use for adult spinal deformity (ASD) surgery over the past decade. METHODS A retrospective review of the International Spine Study Group prospective multicenter database was performed to identify ASD patients treated surgically from 2008 to 2018. For assessment of rhBMP-2 use over time, 3 periods were created: 2008–2011, 2012–2015, and 2016–2018. RESULTS Of the patients identified, 1180 met inclusion criteria, with a mean age 60 years and 30% of patients requiring revision surgery; rhBMP-2 was used in 73.9% of patients overall. The mean rhBMP-2 dose per patient was 23.6 mg. Patients receiving rhBMP-2 were older (61 vs 58 years, p < 0.001) and had more comorbidities (Charlson Comorbidity Index 1.9 vs 1.4, p < 0.001), a higher rate of the Scoliosis Research Society–Schwab pelvic tilt modifier (> 0; 68% vs 62%, p = 0.026), a greater deformity correction (change in pelvic incidence minus lumbar lordosis 15° vs 12°, p = 0.01), and more levels fused (8.9 vs 7.9, p = 0.003). Over the 3 time periods, the overall rate of rhBMP-2 use increased and then stabilized (62.5% vs 79% vs 77%). Stratified analysis showed that after an overall increase in rhBMP-2 use, only patients who were younger than 50 years, those who were smokers, those who received a three-column osteotomy (3CO), and patients who underwent revision sustained an increased rate of rhBMP-2 use between the later two periods. No similar increases were noted for older patients, nonsmokers, primary surgery patients, and patients without a 3CO. The total rhBMP-2 dose decreased over time (26.6 mg vs 24.8 mg vs 20.7 mg, p < 0.001). After matching patients by preoperative alignment, 215 patients were included, and a significantly lower rate of complications leading to revision surgery was observed within the 2012–2015 period compared with the 2008–2011 (21.4% vs 13.0%, p = 0.029) period, while rhBMP-2 was increasingly used (80.5% vs 66.0%, p = 0.001). There was a trend toward a lower rate of pseudarthrosis for patients in the 2012–2015 period, but this difference did not reach statistical significance (7% vs 4.2%, p = 0.283). CONCLUSIONS The authors found that rhBMP-2 was used in the majority of ASD patients and was more commonly used in those with greater deformity correction. Additionally, over the last 10 years, rhBMP-2 was increasingly used for ASD patients, but the dose has decreased.

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“…The rhBMP-2 solution has a pH 4. 5 [18,19]. After cross-linking, the remaining BDDE was removed by dialysis with 1X phosphate buffered saline (Sigma-Aldrich, USA; PBS) for 5 days.…”

Section: Preparation Of Rhbmp-2mentioning

confidence: 99%

“…Bone morphogenetic proteins (BMPs), members of the transforming growth factor-β (TGF-β) superfamily, received extensive attention after being demonstrated to have the ability to stimulate bone formation [4][5][6][7]. And BMPs are added to synthetic bone in order to improve the osteoinductivity of bone substitutes.…”

Section: Introductionmentioning

confidence: 99%

The efficacy of rhBMP-2 loaded hydrogel composite on bone formation around dental implants in mandible bone defects of minipigs

Lyu

Lee

2020

Biomater Res

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Background: In dental or orthopedic surgery, bone substitutes are inserted with implants to promote osteogenesis and enhance osseointegration. The purpose of this research was to evaluate the efficacy of rhBMP-2 (recombinant human bone morphogenetic protein-2) loaded hydrogel composite for bone formation around dental implant in minipig mandible bone defect models. Methods: We made bone defects with a diameter of 4 mm in minipig mandibles and inserted implants of the same size, to mimic the cases of inserting the screws in the bone defect or poor-quality bone. The rhBMP-2 (300 μg) loaded hydrogel composite (0.5 cc) inserted in the bone defect with the implant in the rhBMP-2 group. After 4 weeks, the mandibles were harvested to evaluate the new bone mass around implants using plain radiographs, micro-CT, and histology. Results: The micro-CT analysis result showed that the quantity of new bone generation around the implant in the rhBMP-2 group was greater than that in the other groups. Comparing the ratios of bone to implant area in three groups by histology, the amount of newly formed bone in the rhBMP-2 group was the most. Conclusion: The rhBMP-2 loaded hydrogel composite promotes osteogenesis around dental implant in minipig mandible bone defect, and enhance osseointegration between the dental implant and host bone.

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Long-Segment Fusion for Adult Spinal Deformity Correction Using Low-Dose Recombinant Human Bone Morphogenetic Protein-2

Abstract: ASD, adult spinal deformityICBG, iliac crest bone graftOR, odds ratiorhBMP-2, recombinant human bone morphogenetic protein-2RR, risk ratioTCO, 3-column osteotomy.

Cited by 19 publications

References 57 publications

Bone morphogenetic protein‐2 is a stronger inducer of osteogenesis within muscle tissue than heterodimeric bone morphogenetic protein‐2/6 and ‐2/7: Implications for expedited gene‐enhanced bone repair

Bone morphogenetic protein‐2 is a stronger inducer of osteogenesis within muscle tissue than heterodimeric bone morphogenetic protein‐2/6 and ‐2/7: Implications for expedited gene‐enhanced bone repair

Use of rhBMP-2 for adult spinal deformity surgery: patterns of usage and changes over the past decade

The efficacy of rhBMP-2 loaded hydrogel composite on bone formation around dental implants in mandible bone defects of minipigs

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