Ultra-Low-Dose Recombinant Human Bone Morphogenetic Protein-2 for 3-Level Anterior Cervical Diskectomy and Fusion

Abstract

This study evaluated the safety of 3-level anterior cervical diskectomy and fusion (ACDF) with ultra-low-dose recombinant bone morphogenetic protein-2 (rhBMP-2). Thirty-seven consecutive patients with cervical spondylotic myelopathy who were treated with 3-level ACDF and rhBMP-2 were evaluated. Complications such as airway or cervical swelling or hematoma were not observed. The rate of dysphagia was no different at 1, 2, and 6 months postoperatively compared with reports in the literature without rhBMP-2. There were significant improvements in VAS neck/arm pain, Oswestry Neck Disability Index, and cervical lordosis. The use of ultra-low-dose rhBMP-2 for 3-level ACDF may be efficacious for surgically addressing 3-level spondylotic myelopathy.

Local steroids and dysphagia in anterior cervical discectomy and fusion—does the employment of rhBMP-2 make their use a necessity?

“…Similarly, Kukreja et al reported lower incidence of postoperative dysphagia with lower rhBMP-2 doses (11). Pourtaheri et al studied the safety and efficacy of a minimum rhBMP-2 dose in three-level ACDF procedures (12). They concluded that the rates of dysphagia in their patients were similar with those of series using no rhBMP-2 (12).…”

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

“…In the final analysis, 29 studies including a total of 1,539,021 cases fulfilled the predefined inclusion criteria and were included ( Figure 1 ). These publications were full-text articles [ [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] ]. Examination of the references listed for these studies did not yield any further studies for evaluation.…”

“…The characteristics of included studies are shown in Table 1 . Among the included studies, there was 1 small sampled RCT without clarified confidence interval and <80% follow-up (level of evidence: 2b) [ 39 ]; 2 prospective nonrandomised, historically controlled trials (level of evidence: 2b) [ 24 , 32 ]; 2 prospective therapeutic cohort studies (level of evidence: 2b) [ 35 , 38 ]; 1 prospective study that collected data prospectively without controls (level of evidence: 4) [ 44 ]; 14 retrospective studies comparing contemporary series of patients (level of evidence: 3b) [ 22 , 23 , 25 , 26 , [28] , [29] , [30] , [31] , 33 , 34 , 37 , 42 , [45] , [46] , [47] ]; 2 retrospective studies using historical series as controls (level of evidence: 4) [ 36 , 41 ] and remaining 7 retrospective studies without controls (level of evidence: 4) [ [19] , [20] , [21] , 27 , 40 , 43 , 48 ]. The primary exposure or intervention was rhBMP-2.…”

“…The key efficacy outcome, fusion rate, was evaluated in 17 studies, which contained 11 two-arm studies [ [22] , [23] , [24] , [25] , [26] , 29 , 31 , 35 , 36 , 38 , 39 ] and 6 one-arm studies [ 20 , 21 , 43 , 44 , 46 , 48 ]. To investigate the superiority of fusion rates between rhBMP-2 and non-rhBMP-2 in ACDF, 11 studies comparing the two treatments showed that groups choosing rhBMP-2 had significantly higher fusion rate in ACDF than non-rhBMP-2, 98.28% and 95.17%, respectively (OR:7.01, 95% CI: 3.90–12.60, p < 0.00001).…”

“…This part of meta-analysis is shown in Fig. 4 A and B. Lastly, there is one study conducting one-arm trial to investigate rhBMP-2 effects on 3-level ACDF, which reported one patient who was undertaking an anterior cervical plate removal due to dysphagia among 37 patients; others reached fusion at six months after surgery so that the total fusion rate was 97.3% [ 46 ]. Other 27 studies conducting multi-level ACDF did not separate the data according to the level of ACDF.…”