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

Robert J. Jackson, Reginald J. Davis, Gregory A. Hoffman, Hyun W. Bae, Michael S. Hisey, Kee D Kim, Steven E. Gaede, Pierce Dalton Nunley

Research output: Contribution to journalArticle

27 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)734-745
Number of pages12
JournalJournal of Neurosurgery: Spine
Volume24
Issue number5
DOIs
StatePublished - May 1 2016

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Total Disc Replacement
Diskectomy
Prostheses and Implants
Randomized Controlled Trials
Therapeutics

Keywords

  • Anterior cervical discectomy and fusion
  • Cervical disc arthroplasty
  • Cervical spine
  • Clinical trial
  • Fusion
  • Mobi-C Cervical Disc Prosthesis
  • Reoperation
  • Subsequent surgical intervention
  • Total disc replacement

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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. / Jackson, Robert J.; Davis, Reginald J.; Hoffman, Gregory A.; Bae, Hyun W.; Hisey, Michael S.; Kim, Kee D; Gaede, Steven E.; Nunley, Pierce Dalton.

In: Journal of Neurosurgery: Spine, Vol. 24, No. 5, 01.05.2016, p. 734-745.

Research output: Contribution to journalArticle

Jackson, Robert J. ; Davis, Reginald J. ; Hoffman, Gregory A. ; Bae, Hyun W. ; Hisey, Michael S. ; Kim, Kee D ; Gaede, Steven E. ; Nunley, Pierce Dalton. / 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. In: Journal of Neurosurgery: Spine. 2016 ; Vol. 24, No. 5. pp. 734-745.
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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.",
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T1 - Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion

T2 - A prospective randomized clinical trial with 5-year follow-up

AU - Jackson, Robert J.

AU - Davis, Reginald J.

AU - Hoffman, Gregory A.

AU - Bae, Hyun W.

AU - Hisey, Michael S.

AU - Kim, Kee D

AU - Gaede, Steven E.

AU - Nunley, Pierce Dalton

PY - 2016/5/1

Y1 - 2016/5/1

N2 - 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.

AB - 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.

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KW - Cervical spine

KW - Clinical trial

KW - Fusion

KW - Mobi-C Cervical Disc Prosthesis

KW - Reoperation

KW - Subsequent surgical intervention

KW - Total disc replacement

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