Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results

Reginald James Davis, Pierce D alton Nunley, Kee D. Kim, Michael S. Hisey, Robert J. Jackson, Hyun W. Bae, Gregory A. Hoffman, Steven E. Gaede, Guy O. Danielson, Charles Gordon, Marcus B. Stone

Research output: Contribution to journalArticle

Abstract

OBJECT: The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up.

METHODS: A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the U.S. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery.

RESULTS: At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure.

CONCLUSIONS: Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels. Clinical trial registration no.: NCT00389597 ( clinicaltrials.gov ).

Original languageEnglish (US)
Pages (from-to)15-25
Number of pages11
JournalJournal of Neurosurgery: Spine
Volume22
Issue number1
DOIs
StatePublished - Jan 1 2015

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Total Disc Replacement
Diskectomy
Multicenter Studies
Randomized Controlled Trials
Outcome Assessment (Health Care)
Equipment Failure
Safety
Articular Range of Motion
Health Surveys
Patient Satisfaction
Neck

Keywords

  • ACDF = anterior cervical discectomy and fusion
  • AE = adverse event
  • anterior cervical discectomy and fusion
  • artificial disc
  • CEC = clinical events committee
  • cervical arthroplasty
  • degenerative disc disease
  • HO = heterotopic ossification
  • IDE = investigational device exemption
  • MCS = Mental Component Summary
  • Mobi-C
  • multilevel
  • NDI = Neck Disability Index
  • NSAID = nonsteroidal antiinflammatory drug
  • PCS = Physical Component Summary
  • ROM = range of motion
  • SEM = standard error of the mean
  • SF-12 = 12-Item Short Form Health Survey
  • TDR = total disc replacement
  • VAS = visual analog scale

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion : a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results. / Davis, Reginald James; Nunley, Pierce D alton; Kim, Kee D.; Hisey, Michael S.; Jackson, Robert J.; Bae, Hyun W.; Hoffman, Gregory A.; Gaede, Steven E.; Danielson, Guy O.; Gordon, Charles; Stone, Marcus B.

In: Journal of Neurosurgery: Spine, Vol. 22, No. 1, 01.01.2015, p. 15-25.

Research output: Contribution to journalArticle

Davis, Reginald James ; Nunley, Pierce D alton ; Kim, Kee D. ; Hisey, Michael S. ; Jackson, Robert J. ; Bae, Hyun W. ; Hoffman, Gregory A. ; Gaede, Steven E. ; Danielson, Guy O. ; Gordon, Charles ; Stone, Marcus B. / Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion : a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results. In: Journal of Neurosurgery: Spine. 2015 ; Vol. 22, No. 1. pp. 15-25.
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abstract = "OBJECT: The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up.METHODS: A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the U.S. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery.RESULTS: At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure.CONCLUSIONS: Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels. Clinical trial registration no.: NCT00389597 ( clinicaltrials.gov ).",
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T2 - a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results

AU - Davis, Reginald James

AU - Nunley, Pierce D alton

AU - Kim, Kee D.

AU - Hisey, Michael S.

AU - Jackson, Robert J.

AU - Bae, Hyun W.

AU - Hoffman, Gregory A.

AU - Gaede, Steven E.

AU - Danielson, Guy O.

AU - Gordon, Charles

AU - Stone, Marcus B.

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N2 - OBJECT: The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up.METHODS: A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the U.S. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery.RESULTS: At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure.CONCLUSIONS: Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels. Clinical trial registration no.: NCT00389597 ( clinicaltrials.gov ).

AB - OBJECT: The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up.METHODS: A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the U.S. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery.RESULTS: At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure.CONCLUSIONS: Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels. Clinical trial registration no.: NCT00389597 ( clinicaltrials.gov ).

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KW - AE = adverse event

KW - anterior cervical discectomy and fusion

KW - artificial disc

KW - CEC = clinical events committee

KW - cervical arthroplasty

KW - degenerative disc disease

KW - HO = heterotopic ossification

KW - IDE = investigational device exemption

KW - MCS = Mental Component Summary

KW - Mobi-C

KW - multilevel

KW - NDI = Neck Disability Index

KW - NSAID = nonsteroidal antiinflammatory drug

KW - PCS = Physical Component Summary

KW - ROM = range of motion

KW - SEM = standard error of the mean

KW - SF-12 = 12-Item Short Form Health Survey

KW - TDR = total disc replacement

KW - VAS = visual analog scale

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