title: Four-year follow-up results of lumbar spine arthrodesis using the Bagby and Kuslich lumbar fusion cage.
abstract: METHODS
  This was a prospective multicenter clinical trial of a lumbar interbody fusion cage with a minimum of 4 years' follow-up.
  
  
  OBJECTIVE
  To determine whether the early positive clinical results in fusions with lumbar cages, such as the Bagby and Kuslich (BAK) cage, are maintained beyond 2 years.
  
  
  BACKGROUND
  Threaded cages have been used increasingly for the treatment of symptomatic degenerative intervertebral disc disease. Concerns about the long-term clinical outcomes of this procedure have been posed, particularly regarding bony fusion viability, revision rates, potential adjacent level disease, and late complications.
  
  
  METHODS
  The study cohort was a 196-patient subset from a prospective investigational device exemption. In addition to early postoperative examinations, these patients were examined biannually with a minimum of 4 years' follow-up. Patient outcome was assessed by a 6-point scale that evaluated pain relief, and functional improvement was determined by changes in activities of daily living. Fusion rates and return to work were determined. Complications and secondary operations were reported and categorized as non-device related or device related.
  
  
  RESULTS
  The patient cohort with 4-year follow-up represented 25.6% of the original study population eligible at that time. Overall, the largest percentage of pain relief and functional improvements occurred by 3 months, and these improvements were maintained at each follow-up. Overall fusion rate was 91.7% and 95. 1% at 2 and 4 years, respectively. In this cohort, 39.5% of patients were working or were able to work within 3 months of surgery. After 4 years, 62.7% of patients were gainfully employed or able to work. The late-occurring complication rate in this cohort was 13.8% (27/196). Complications necessitating a second operation occurred in 8.7% (17/196), whereas reoperations that were deemed device related were performed in 3.1% (6/196).
  
  
  CONCLUSIONS
  This study indicates that the early positive benefits of interbody fusion cage procedures are maintained through 4 years with acceptably low morbidity.
authors.affiliation: St. Croix Orthopedics, Stillwater, Minnesota 55435, USA.
authors.forename: S D
authors.initials: SD
authors.lastname: Kuslich
authors.forename: G
authors.initials: G
authors.lastname: Danielson
authors.forename: J D
authors.initials: JD
authors.lastname: Dowdle
authors.forename: J
authors.initials: J
authors.lastname: Sherman
authors.forename: B
authors.initials: B
authors.lastname: Fredrickson
authors.forename: H
authors.initials: H
authors.lastname: Yuan
authors.forename: S L
authors.initials: SL
authors.lastname: Griffith
mesh_terms: D015331:Cohort Studies; D003710:Demography; D015194:Diffusion Chambers, Culture / Q000295:instrumentation* / Q000706:statistics & numerical data; D004651:Employment / Q000706:statistics & numerical data; D005500:Follow-Up Studies; D006801:Humans; D016268:Internal Fixators / Q000009:adverse effects / Q000592:standards*; D008159:Lumbar Vertebrae / Q000601:surgery*; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D010146:Pain / Q000534:rehabilitation / Q000601:surgery; D010147:Pain Measurement / Q000706:statistics & numerical data; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology; D011446:Prospective Studies; D020127:Recovery of Function; D012086:Reoperation / Q000706:statistics & numerical data; D013123:Spinal Fusion / Q000009:adverse effects / Q000295:instrumentation* / Q000534:rehabilitation; D013997:Time Factors; D016896:Treatment Outcome