title: An 11-year minimum follow-up of the Charite III lumbar disc replacement for the treatment of symptomatic degenerative disc disease.
abstract: OBJECTIVE
  To report our 11-year minimum clinical and radiological outcomes, as well as complications of the Charite III total disc replacement (TDR).
  
  
  METHODS
  A total of 35 patients indicated for total disc replacement were implanted with the Charite III prosthesis. Clinical evaluation included visual analog scale (VAS) for back pain and the Oswestry disability index (ODI). Radiological parameters of intervertebral disc height (IDH), range of motion (ROM), lumbar lordosis, lumbar scoliosis and prosthesis position were evaluated. Complications and reoperation rates were also assessed.
  
  
  RESULTS
  Thirty-two patients had a minimum 11-year follow-up, and 33 prostheses were implanted. The mean follow-up time was 11.8 years, ranging from 11.3 to 13.8 years. Twenty-eight patients (87.5 %) had a successful outcome, as defined by the FDA. Reoperation was performed in 2 patients for adjacent segment degeneration and pedicle fracture (1 case each). Both VAS and ODI scores showed significant improvement compared to baseline. At the final follow-up, the ROM of both the index- and adjacent-level showed an obvious decrease. The IDH of the index level showed a tendency to decrease, but the difference was not significant. The IDH of adjacent levels were not significantly affected by the surgery. Mean lumbar lordosis was increased at the final follow-up, and lumbar scoliosis over 3° was observed in 12 patients (37.5%), with a mean angle of 5.6° (range 3°-12°). Of all 35 prostheses, 15 were left-shifted, 3 were right-shifted and 14 were just in the middle. In the coronal plane, 25 were rated as ideally placed, 5 were discretely shifted, 4 were slightly shifted and 1 was markedly shifted. In the sagittal plane, only 12 prostheses were rated as ideally placed, 14 were discretely shifted and 9 were suboptimally placed. Prosthesis subsidence was noted in 3 (9.4%) patients (the subsidence distances were 3.1, 4.2 and 2.8 mm, respectively). Heterotopic ossification was detected in 25 segments (71.4%), consisting of Class-I heterotopic ossification in 7 segments (20.0%), Class-II in 9 segments (25.7%), and Class-III in 9 segments (25.7%). Class-IV heterotopic ossification was not observed.
  
  
  CONCLUSIONS
  The cumulative survival was 100% at a mean follow-up of 11.8 years. Clinical and radiological results were satisfactory and long-term clinical results were maintained for a mean follow-up of 11.8 years. Reoperation and complication rates are acceptable, and our study does not substantiate the fear of reoperation or late complications. The results of our long-term follow-up indicate that, with strict indication, TDR is a safe and effective procedure as an alternative to lumbar fusion.
authors.affiliation: Beijing Chao-yang Hospital, Capital Medical University, Beijing, China, spinelu@163.com.
authors.forename: Shi-bao
authors.initials: SB
authors.lastname: Lu
authors.forename: Yong
authors.initials: Y
authors.lastname: Hai
authors.forename: Chao
authors.initials: C
authors.lastname: Kong
authors.forename: Qing-yi
authors.initials: QY
authors.lastname: Wang
authors.forename: Qingjun
authors.initials: Q
authors.lastname: Su
authors.forename: Lei
authors.initials: L
authors.lastname: Zang
authors.forename: Nan
authors.initials: N
authors.lastname: Kang
authors.forename: Xiang-long
authors.initials: XL
authors.lastname: Meng
authors.forename: Yu
authors.initials: Y
authors.lastname: Wang
mesh_terms: D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007403:Intervertebral Disc / Q000601:surgery*; D055959:Intervertebral Disc Degeneration / Q000601:surgery*; D007595:Joint Prosthesis; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D016059:Range of Motion, Articular; D012086:Reoperation; D059145:Total Disc Replacement / Q000379:methods*; D016896:Treatment Outcome