title: Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up.
abstract: OBJECTIVE Cervical total disc replacement (TDR) has been shown in a number of prospective clinical studies to be a viable treatment alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic degenerative disc disease. In addition to preserving motion, evidence suggests that cervical TDR may result in a lower incidence of subsequent surgical intervention than treatment with fusion. The goal of this study was to evaluate subsequent surgery rates up to 5 years in patients treated with TDR or ACDF at 1 or 2 contiguous levels between C-3 and C-7. METHODS This was a prospective, multicenter, randomized, unblinded clinical trial. Patients with symptomatic degenerative disc disease were enrolled to receive 1- or 2-level treatment with either TDR as the investigational device or ACDF as the control treatment. There were 260 patients in the 1-level study (179 TDR and 81 ACDF patients) and 339 patients in the 2-level study (234 TDR and 105 ACDF patients). RESULTS At 5 years, the occurrence of subsequent surgical intervention was significantly higher among ACDF patients for 1-level (TDR, 4.5% [8/179]; ACDF, 17.3% [14/81]; p = 0.0012) and 2-level (TDR, 7.3% [17/234]; ACDF, 21.0% [22/105], p = 0.0007) treatment. The TDR group demonstrated significantly fewer index- and adjacent-level subsequent surgeries in both the 1- and 2-level cohorts. CONCLUSIONS Five-year results showed treatment with cervical TDR to result in a significantly lower rate of subsequent surgical intervention than treatment with ACDF for both 1 and 2 levels of treatment. Clinical trial registration no.: NCT00389597 ( clinicaltrials.gov ).
authors.affiliation: Orange County Neurosurgical Associates, Laguna Hills;
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Jackson
authors.affiliation: Department of Neurosurgery, Greater Baltimore Neurosurgical Associates, Baltimore, Maryland;
authors.forename: Reginald J
authors.initials: RJ
authors.lastname: Davis
authors.affiliation: Orthopaedics Northeast, Fort Wayne, Indiana;
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Hoffman
authors.affiliation: Department of Research, Cedars Sinai Spine Center, Los Angeles;
authors.forename: Hyun W
authors.initials: HW
authors.lastname: Bae
authors.affiliation: Department of Spine Surgery, Texas Back Institute, Plano, Texas;
authors.forename: Michael S
authors.initials: MS
authors.lastname: Hisey
authors.affiliation: Department of Neurological Surgery, University of California, Davis, Sacramento, California;
authors.forename: Kee D
authors.initials: KD
authors.lastname: Kim
authors.affiliation: Department of Neurosurgery, Oklahoma Brain and Spine Institute, Tulsa, Oklahoma; and.
authors.forename: Steven E
authors.initials: SE
authors.lastname: Gaede
authors.affiliation: Department of Orthopedics, Spine Institute of Louisiana, Shreveport, Louisiana.
authors.forename: Pierce Dalton
authors.initials: PD
authors.lastname: Nunley
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002574:Cervical Vertebrae / Q000601:surgery*; D017586:Diskectomy / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007403:Intervertebral Disc / Q000601:surgery; D055959:Intervertebral Disc Degeneration / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012086:Reoperation / Q000706:statistics & numerical data; D013123:Spinal Fusion / Q000706:statistics & numerical data*; D059145:Total Disc Replacement / Q000706:statistics & numerical data*; D016896:Treatment Outcome; D055815:Young Adult
keywords: ACDF = anterior cervical discectomy and fusion; IDE = Investigational Device Exemption; Mobi-C Cervical Disc Prosthesis; NDI = neck disability index; TDR = total disc replacement; anterior cervical discectomy and fusion; cervical disc arthroplasty; cervical spine; clinical trial; fusion; reoperation; subsequent surgical intervention; total disc replacement