Abstract:
STUDY DESIGN:A prospective study with historical controls. OBJECTIVES:To evaluate and compare the safety and effectiveness of recombinant human bone morphogenetic protein-2 (rhBMP-2) with allograft for anterior cervical discectomy and fusion (ACDF) in patients with symptomatic single-level cervical degenerative disk disease. SUMMARY OF BACKGROUND DATA:rhBMP-2 is an osteoinductive protein that has been shown to induce fusion when used as an implant with a suitable carrier in spine surgery. However, some previous studies have shown rhBMP-2 use to be associated with a higher complication rate. METHODS:Investigational patients (224) with single-level cervical degenerative disk disease underwent ACDF with rhBMP-2 at a dose of 0.6 or 1.05 mg and were compared with historical control patients (486) treated with allograft spacer and cervical plate. RESULTS:At 24 months, improvement was significantly greater in the investigational group (37.1 points) than in the control group for Neck Disability Index (P=0.002) and arm pain (P=0.031). The overall neurological success rate was higher in the investigational group (P<0.001). Neck pain and general health status (SF-36 PCS and MCS) were similar. Fusion rate in the investigational group was higher than in the control group (99.4% vs. 87.2%, P=0.002).Cumulative adverse event rates at 24 months were similar; however, higher rates of dysphagia (P=0.001), local swelling (P=0.024), oropharyngeal pain (P=0.013), neck pain (P=0.019), and foraminal stenosis (P=0.002) were observed in the investigational group. Heterotopic ossification was also higher in the investigational group. CONCLUSIONS:At doses of 0.6 or 1.05 mg in a PEEK interbody cage, rhBMP-2 was effective in inducing fusion and improving Neck Disability Index and arm pain in single-level ACDF patients; however, higher rates of certain adverse events were observed in the investigational group. LEVEL OF EVIDENCE:Level 2.
journal_name
Clin Spine Surgjournal_title
Clinical spine surgeryauthors
Burkus JK,Dryer RF,Arnold PM,Foley KTdoi
10.1097/BSD.0000000000000409subject
Has Abstractpub_date
2017-11-01 00:00:00pages
E1321-E1332issue
9eissn
2380-0186issn
2380-0194journal_volume
30pub_type
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