Comparison of rhBMP-2 versus Autogenous Iliac Crest Bone Graft for 2-Level Anterior Cervical Discectomy and Fusion for Cervical Spondylotic Myelopathy

Tan, Bingyi; Wang, Haiyan; Dong, Jing; Yuan, Zenong; Wang, Dachuan; Wang, Feng

doi:10.12659/msm.894656

Cited by 13 publications

(17 citation statements)

References 48 publications

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“…In our study, the average dose of rhBMP-2 was 0.50 ± 0.09 mg per level compared with 0.6-2.1 mg per level used in the scientific literature. 4,5,16,34,35 We believe that our lowdose protocol decreases morbidity associated with ACF rhBMP-2 usage while it successfully augments fusion without significant expense. In each case, either an x-small or xx-small rhBMP-2 kit was used at a cost of $1905.00 and $995.00, respectively.…”

Section: Discussionmentioning

confidence: 90%

Safety and efficacy of low-dose rhBMP-2 use for anterior cervical fusion

Mendenhall

Priddy

Mobasser

et al. 2021

Neurosurgical Focus

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OBJECTIVE The use of recombinant human bone morphogenetic protein 2 (rhBMP-2) in routine anterior cervical fusion (ACF) is controversial. Early reports described high complication rates. A variety of dosing regimens ranging from 0.6 to 2.1 mg per level fused have been reported. The authors hypothesized that the high amounts of rhBMP-2 used in these studies led to the high complication rates observed; therefore, they set out to evaluate the safety and efficacy of low-dose rhBMP-2 for use in ACFs. METHODS Patient inclusion criteria were 1) age 18 to 70 years; 2) initial stand-alone ACF construct; 3) fusion augmentation with rhBMP-2; and 4) at least 1 year of radiographic follow-up. A successful fusion was defined by either 1) lateral flexion-extension radiographs with less than 1 mm of movement across the fused spinous processes, or 2) bone bridging at least half of the fusion area originally achieved by surgery on fine-cut CT. Patient demographics, perioperative data, and postoperative complications were recorded. RESULTS A total of 198 patients met the inclusion criteria and were included for analysis. Sixty-two patients (31%) were smokers. The median number of levels fused was 2 (IQR 1.25). The mean dose of rhBMP-2 was 0.50 ± 0.09 mg per level. Twenty-two (11%) patients experienced dysphagia. Eleven (6%) patients experienced cervical swelling. Two (1%) patients returned to the operating room (OR) for postoperative hematoma. One (0.5%) patient returned to the OR for seroma. Two (1%) patients experienced pseudarthrosis requiring a posterior fusion. Three (2%) patients experienced a new postoperative neurological deficit that had recovered by last the follow-up. Overall, 190 (96%) patients experienced solid arthrodesis over an average of 15 months of follow-up. There was no difference in fusion rates between patients who were either smokers or nonsmokers (p = 0.7073). CONCLUSIONS The use of low-dose rhBMP-2 safely and effectively augmented anterior cervical arthrodesis. The low-dose protocol assessed in this study appeared to significantly reduce complications associated with rhBMP-2 use in ACF compared with the literature. The authors have determined that using low-dose rhBMP-2 in patients who are smokers, those with multilevel ACFs, or others at high risk of developing pseudarthrosis is recommended.

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Section: Discussionmentioning

confidence: 90%

Safety and efficacy of low-dose rhBMP-2 use for anterior cervical fusion

Mendenhall

Priddy

Mobasser

et al. 2021

Neurosurgical Focus

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“…Contrasting results were published when comparing the incidence of dysphagia between the BMP-2 and control groups. Tan et al 18 did not report a difference, while Moreover, significantly severe dysphagia (SWAL-QOL scale) was seen in the 2-level BMP-2 group than the control group (.778 vs .318). However, the incidence of dysphagia was not higher in the BMP-2 group than in the control group (29% vs 32%).…”

Section: Complications Adverse Events Revisionsmentioning

confidence: 87%

“…The most frequently used included visual analog scores (VAS) for neck and/or arm pain (n = 6); Neck Disability Index (NDI) (N = 4); and Japanese Orthopedic Association (JOA) score (N = 3). 8,9,18 Otherwise, no significant differences were found when comparing the BMP-2 groups with the control groups or when analyzing single-level vs multi-level surgeries.…”

Section: Patient Reported Outcome Measuresmentioning

confidence: 95%

“…In 7 studies fusion was evaluated by blinded independent observers or radiologists. 10,[13][14][15][16][17][18] In the other studies it was not explicitly stated that the assessment of fusion outcome was scored blinded to the treatment. Evaluation of fusion was determined at a number of different time-points, with most studies reporting either 12-month (N = 7) or 24-month results (N = 6).…”

Section: Fusion Ratesmentioning

confidence: 99%

“…Contrastingly, Tan et al did not report differences in dysphagia incidence between groups at all. 18 Furthermore, Lu et al performed a correlation analysis between the total dose of BMP-2 used and the dysphagia score, and reported a weak correlation. This implies that, while the dose of BMP-2 influences the severity of dysphagia, it is only 1 of many factors playing a role in dysphagia after ACDF.…”

Section: Complications Adverse Events Revisionsmentioning

confidence: 99%

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The Use of Osteobiologics in Single versus Multi-Level Anterior Cervical Discectomy and Fusion: A Systematic Review

Hoffmann,

Ricciardi,

Yurac

et al. 2024

Global Spine Journal

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Study Design Systematic literature review. Objectives In this study we assessed evidence for the use of osteobiologics in single vs multi-level anterior cervical discectomy and fusion (ACDF) in patients with cervical spine degeneration. The primary objective was to compare fusion rates after single and multi-level surgery with different osteobiologics. Secondary objectives were to compare differences in patient reported outcome measures (PROMs) and complications. Methods After a global team of reviewers was selected, a systematic review using different repositories was performed, confirming to PRISMA and GRADE guidelines. In total 1206 articles were identified and after applying inclusion and exclusion criteria, 11 articles were eligible for analysis. Extracted data included fusion rates, definition of fusion, patient reported outcome measures, types of osteobiologics used, complications, adverse events and revisions. Results Fusion rates ranged from 87.7% to 100% for bone morphogenetic protein 2 (BMP-2) and 88.6% to 94.7% for demineralized bone matrix, while fusion rates reported for other osteobiologics were lower. All included studies showed PROMs improved significantly for each osteobiologic. However, no differences were reported when comparing osteobiologics, or when comparing single vs multi-level surgery specifically. Conclusion The highest fusion rates after 2-level ACDF for cervical spine degeneration were reported when BMP-2 was used. However, PROMs did not differ between the different osteobiologics. Further blinded randomized trials should be performed to compare the use of BMP-2 in single vs multi-level ACDF specifically.

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Exploratory meta-analysis on dose-related efficacy and complications of rhBMP-2 in anterior cervical discectomy and fusion: 1,539,021 cases from 2003 to 2017 studies

Wen

Jiang

Yang

et al. 2020

Journal of Orthopaedic Translation

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s Background/Objective Anterior cervical discectomy and fusion (ACDF), commonly using autogenous iliac bone graft may be limited by donor site availability, donor-site morbidity, lower fusion rate among specific patients and longer surgical time. Surgeons used rhBMP-2 as an alternative in order to fill these clinical needs. However, studies comparing with and without rhBMP-2 in ACDF have reported conflicting results on efficacy and complications. Therefore, the purpose of this article was to evaluate efficacy and complications through dose-related rhBMP-2 and surgical level-dependence in ACDF. Methods We comprehensively searched PubMed and the Cochrane Library and performed a systematic review and cumulative meta-analysis of all randomized controlled trials (RCTs), prospective and retrospective comparative studies assessing with and without rhBMP-2 treatments. Results 1 RCTs, 4 prospective studies and 24 retrospective studies including a total of 1,539,021 cases were identified. Patients in ACDF with rhBMP-2 might benefit from significantly higher fusion rates than that in non-rhBMP-2, not only total value but also in 3 tiers of rhBMP-2 doses. It is worth noting that the low dose of rhBMP-2 (<0.7 mg/level) showed highest fusion rate among all rhBMP-2 doses. Patients in rhBMP-2 also experienced higher complication rate, dysphagia and wound infections than that in non-rhBMP-2. In 2-level ACDF, the fusion rate was significantly better in rhBMP-2 than non-rhBMP-2 but not for complication rate. Surgery operative time, lengths of hospital stay and neurologic symptoms did not differ significantly between two treatments. Conclusions rhBMP-2 chosen in ACDF offered higher fusion, but also higher complication rate with more dysphagia and wound infections than non-rhBMP-2. To gain the efficacy and safety, rhBMP-2 dosing recommendations for ACDF would be better < 0.7 mg/level. Moreover, rhBMP-2 may be an option to improve nonunion in high risk of multi-level ACDF. The translational potential of this article This article indicated that the product development of facilities used in ACDF, the dose of rhBMP-2 may be lower than 0.7 mg/level was enough to gain the good fusion rates. However, the complications were higher in patients used rhBMP-2, therefore the manufacturers should pay attention to mitigate such side effects.

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Comparison of rhBMP-2 versus Autogenous Iliac Crest Bone Graft for 2-Level Anterior Cervical Discectomy and Fusion for Cervical Spondylotic Myelopathy

Cited by 13 publications

References 48 publications

Safety and efficacy of low-dose rhBMP-2 use for anterior cervical fusion

Safety and efficacy of low-dose rhBMP-2 use for anterior cervical fusion

The Use of Osteobiologics in Single versus Multi-Level Anterior Cervical Discectomy and Fusion: A Systematic Review

Exploratory meta-analysis on dose-related efficacy and complications of rhBMP-2 in anterior cervical discectomy and fusion: 1,539,021 cases from 2003 to 2017 studies

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