Clinical and Radiographic Outcomes in Patients Undergoing Single-level Anterior Cervical Arthrodesis

John K. Burkus, Randall F. Dryer, Paul M. Arnold, Kevin Foley

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)E1321-E1332
JournalClinical Spine Surgery
Volume30
Issue number9
DOIs
StatePublished - Jan 1 2017

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Arthrodesis
Diskectomy
Neck Pain
Pain
Allografts
Arm
Neck
Heterotopic Ossification
Control Groups
Deglutition Disorders
Health Status
Pathologic Constriction
Spine
recombinant human bone morphogenetic protein-2
Prospective Studies
Safety
Proteins

All Science Journal Classification (ASJC) codes

  • Surgery
  • Orthopedics and Sports Medicine
  • Clinical Neurology

Cite this

Clinical and Radiographic Outcomes in Patients Undergoing Single-level Anterior Cervical Arthrodesis. / Burkus, John K.; Dryer, Randall F.; Arnold, Paul M.; Foley, Kevin.

In: Clinical Spine Surgery, Vol. 30, No. 9, 01.01.2017, p. E1321-E1332.

Research output: Contribution to journalArticle

Burkus, John K. ; Dryer, Randall F. ; Arnold, Paul M. ; Foley, Kevin. / Clinical and Radiographic Outcomes in Patients Undergoing Single-level Anterior Cervical Arthrodesis. In: Clinical Spine Surgery. 2017 ; Vol. 30, No. 9. pp. E1321-E1332.
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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.",
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