title: A prospective randomized multicenter clinical evaluation of an anterior cervical fusion cage.
abstract: METHODS
  A prospective, concurrently controlled, randomized, multicenter trial of an anterior Bagby and Kuslich cervical fusion cage (BAK/C; Sulzer Spine-Tech, Minneapolis, MN) for treatment of degenerative disc disease of the cervical spine.
  
  
  OBJECTIVE
  To report clinical results with maximum 24-month follow-up of fusions performed with the BAK/C fusion cage.
  
  
  BACKGROUND
  Threaded lumbar cages have been used during the past decade as a safe and effective surgical solution for chronic disabling low back pain. Threaded cages have now been developed for use in anterior cervical interbody fusions to obviate the need for allografts or autogenous bone grafting procedures while providing initial stability during the fusion process.
  
  
  METHODS
  Patients with symptomatic cervical discogenic radiculopathy were treated with either anterior cervical discectomy with uninstrumented bone-only fusion (ACDF) or BAK/C fusion cage(s). Independent radiographic assessment of fusion was made and patient-based outcome was assessed by visual analog pain scale and a Short Form (SF)-36 Health Status Questionnaire.
  
  
  RESULTS
  Data analysis included 344 patients at 1 year and 180 at 2 years. When the two cage groups (hydroxya, patite-coated or noncoated) were compared with the ACDF group, similar outcomes were noted for duration of surgery, hospital stay, improvements in neck pain and radicular pain in the affected limb, improvements in the SF-36 Physical Component subscale and Mental Component subscale, and the patients' perception of overall surgical outcome. Symptom improvements were maintained at 2 years. A greater percentage of patients with ACDF needed an iliac crest bone harvest than did BAK/C patients (67% vs.- 3%). Successful fusion for one-level procedures at 12 months was 97.9% for the BAK/C groups and 89.7% for the ACDF group (P < 0.05). The complication rate for the ACDF group was 20.4% compared with an overall complication rate of 11.8% with BAK/C. There was no difference in complications that necessitated a second operative procedure.
  
  
  CONCLUSIONS
  These results demonstrate that outcomes after a cervical fusion procedure with a threaded cage are the same as those of a conventional uninstrumented bone-only anterior discectomy and fusion with a low risk of complications and rare need for autogenous bone graft harvest.
authors.affiliation: Oregon Neurosurgery Specialists, Eugene, Oregon 97401, USA. hacker@clipper.net
authors.forename: R J
authors.initials: RJ
authors.lastname: Hacker
authors.forename: J C
authors.initials: JC
authors.lastname: Cauthen
authors.forename: T J
authors.initials: TJ
authors.lastname: Gilbert
authors.forename: S L
authors.initials: SL
authors.lastname: Griffith
mesh_terms: D000328:Adult; D002574:Cervical Vertebrae / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D015331:Cohort Studies; D003710:Demography; D015194:Diffusion Chambers, Culture / Q000295:instrumentation* / Q000592:standards / Q000706:statistics & numerical data; D004185:Disability Evaluation; D006801:Humans; D016268:Internal Fixators / Q000009:adverse effects / Q000592:standards / Q000706:statistics & numerical data*; D007405:Intervertebral Disc Displacement / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D019547:Neck Pain / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D018579:Patient Selection; D011183:Postoperative Complications; D011446:Prospective Studies; D011843:Radiculopathy / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D011859:Radiography; D020127:Recovery of Function; D013123:Spinal Fusion / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D014182:Transplantation, Autologous / Q000706:statistics & numerical data; D016896:Treatment Outcome