title: Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year follow-up.
abstract: BACKGROUND
  The CHARITE artificial disc, a lumbar spinal arthroplasty device, was approved by the United States Food and Drug Administration in 2004 based on two-year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study. No long-term, randomized, prospective study on the CHARITE disc or any other artificial disc has been published to date.
  
  
  OBJECTIVE
  The purpose of this study was to compare the safety and effectiveness at the five-year follow-up time point of lumbar total disc replacement using the CHARITE artificial disc (DePuy Spine, Raynham, MA) with that of anterior lumbar interbody fusion (ALIF) with BAK cages and iliac crest autograft, for the treatment of single-level degenerative disc disease from L4 to S1, unresponsive to nonoperative treatment.
  
  
  METHODS
  Randomized controlled trial-five-year follow-up.
  
  
  METHODS
  Ninety CHARITE patients and 43 BAK patients.
  
  
  METHODS
  Self-reported measures: visual analog scale (VAS); validated Oswestry disability index (ODI version 1.0); Short-Form 36 Questionnaire, and patient satisfaction. Physiologic measures: radiographic range of motion, disc height, and segmental translation. Functional measures: work status.
  
  
  METHODS
  Of the 375 subjects enrolled in the CHARITE IDE trial, 277 were eligible for the five-year study and 160 patients thereof completed the five-year follow-up. The completers included 133 randomized patients. Overall success was defined as improvement> or =15 pts in ODI vs. baseline, no device failure, absence of major complications, and maintenance or improvement of neurological status. Additional clinical outcomes included an ODI questionnaire as well as VAS, SF-36, and patient satisfaction surveys. Work status was tracked for all patients. Safety assessments included occurrence and severity of adverse events and device failures. Radiographic analyses such as index- and adjacent-level range of motion, segmental translation, disc height, and longitudinal ossification were also carried out.
  
  
  RESULTS
  Overall success was 57.8% in the CHARITE group vs. 51.2% in the BAK group (Blackwelder's test: p=0.0359, Delta=0.10). In addition, mean changes from baseline for ODI (CHARITE: -24.0 pts vs. BAK: -27.5 pts), VAS pain scores (CHARITE: -38.7 vs. BAK: -40.0), and SF-36 questionnaires (SF-36 Physical Component Scores [PCS]: CHARITE: 12.6 pts vs. BAK: 12.3 pts) were similar across groups. In patient satisfaction surveys, 78% of CHARITE patients were satisfied vs. 72% of BAK patients. A total of 65.6% patients in the CHARITE group vs. 46.5% patients in the BAK group were employed full-time. This difference was statistically significant (p=0.0403). Long-term disability was recorded for 8.0% of CHARITE patients and 20.9% of BAK patients, a difference that was also statistically significant (p=0.0441). Additional index-level surgery was performed in 7.7% of CHARITE patients and 16.3% of BAK patients. Radiographic findings included operative and adjacent-level range of motion (ROM), intervertebral disc height and segmental translation. At the five-year follow-up, the mean ROM at the index level was 6.0 degrees for CHARITE patients and 1.0 degrees for BAK patients. Changes in disc height were also similar for both CHARITE and BAK patients (0.7 mm for both groups, p=0.9827). Segmental translation was 0.4 and 0.8mm in patients implanted with CHARITE at L4-L5 vs. L5-S1, respectively, and 0.1mm in BAK patients.
  
  
  CONCLUSIONS
  The results of this five-year, prospective, randomized multicenter study are consistent with the two-year reports of noninferiority of CHARITE artificial disc vs. ALIF with BAK and iliac crest autograft. No statistical differences were found in clinical outcomes between groups. In addition, CHARITE patients reached a statistically greater rate of part- and full-time employment and a statistically lower rate of long-term disability, compared with BAK patients. Radiographically, the ROMs at index- and adjacent levels were not statistically different from those observed at two-years postsurgery.
authors.affiliation: Texas Back Institute, 6020 West Parker Road, Suite 200, Plano, TX 75093, USA. rguyer@texasback.com
authors.forename: Richard D
authors.initials: RD
authors.lastname: Guyer
authors.forename: Paul C
authors.initials: PC
authors.lastname: McAfee
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Banco
authors.forename: Fabian D
authors.initials: FD
authors.lastname: Bitan
authors.forename: Andrew
authors.initials: A
authors.lastname: Cappuccino
authors.forename: Fred H
authors.initials: FH
authors.lastname: Geisler
authors.forename: Stephen H
authors.initials: SH
authors.lastname: Hochschuler
authors.forename: Richard T
authors.initials: RT
authors.lastname: Holt
authors.forename: Louis G
authors.initials: LG
authors.lastname: Jenis
authors.forename: Mohamed E
authors.initials: ME
authors.lastname: Majd
authors.forename: John J
authors.initials: JJ
authors.lastname: Regan
authors.forename: Scott G
authors.initials: SG
authors.lastname: Tromanhauser
authors.forename: Douglas C
authors.initials: DC
authors.lastname: Wong
authors.forename: Scott L
authors.initials: SL
authors.lastname: Blumenthal
mesh_terms: D000328:Adult; D019643:Arthroplasty, Replacement / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D004868:Equipment Failure; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007403:Intervertebral Disc / Q000601:surgery; D007405:Intervertebral Disc Displacement / Q000601:surgery*; D007595:Joint Prosthesis / Q000009:adverse effects; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D016059:Range of Motion, Articular; D020127:Recovery of Function; D013123:Spinal Fusion / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration