title: Clinical and Radiographic Outcomes in Patients Undergoing Single-level Anterior Cervical Arthrodesis: A Prospective Trial Comparing Allograft to a Reduced Dose of rhBMP-2.
abstract: METHODS
  A prospective study with historical controls.
  
  
  OBJECTIVE
  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.
  
  
  BACKGROUND
  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.
  
  
  METHODS
  Level 2.
authors.affiliation: *Spine Service, Wilderness Spine Services, Columbus, GA †Central Texas Spine Institute, LLP, Austin, TX ‡Department of Neurosurgery, University of Kansas Medical Center, Kansas City, KS §Department of Neurosurgery and Orthopaedic Surgery, University of Tennessee Health Science Center, Memphis, TN.
authors.forename: John K
authors.initials: JK
authors.lastname: Burkus
authors.forename: Randall F
authors.initials: RF
authors.lastname: Dryer
authors.forename: Paul M
authors.initials: PM
authors.lastname: Arnold
authors.forename: Kevin T
authors.initials: KT
authors.lastname: Foley
mesh_terms: D000328:Adult; D064591:Allografts / Q000187:drug effects*; D055396:Bone Morphogenetic Protein 2 / Q000494:pharmacology*; D002574:Cervical Vertebrae / Q000187:drug effects / Q000601:surgery*; D003710:Demography; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D005260:Female; D006760:Hospitalization; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D019547:Neck Pain / Q000209:etiology; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000494:pharmacology; D013123:Spinal Fusion / Q000009:adverse effects; D016212:Transforming Growth Factor beta / Q000494:pharmacology*; D016896:Treatment Outcome
chemical_list: D055396:Bone Morphogenetic Protein 2; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta; C499469:recombinant human bone morphogenetic protein-2