Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing mobi-C cervical artificial disc to anterior discectomy and fusion in the treatment of symptomatic degenerative disc disease in the cervical spine

Michael S. Hisey, Hyun W. Bae, Reginald Davis, Steven Gaede, Greg Hoffman, Kee D Kim, Pierce D. Nunley, Daniel Peterson, Ralph Rashbaum, John Stokes

Research output: Contribution to journalArticle

44 Citations (Scopus)

Abstract

Background Anterior cervical discectomy and fusion (ACDF) is the gold standard for treating symptomatic cervical disc degeneration. Cervical total disc replacements (TDRs) have emerged as an alternative for some patients. The purpose of this study was to evaluate the safety and effectiveness of a new TDR device compared with ACDF for treating singlelevel cervical disc degeneration. Methods This was a prospective, randomized, controlled, multicenter Food and Drug Administration (FDA) regulated Investigational Device Exemption (IDE) study. A total of 245 patients were treated (164 TDR: 81 ACDF). The primary outcome measure was overall success based on improvement in Neck Disability Index (NDI), no subsequent surgical interventions, and no adverse events (AEs) classified as major complications. Secondary outcome measures included SF-12, visual analog scale (VAS) assessing neck and arm pain, patient satisfaction, radiographic range of motion, and adjacent level degeneration. Patients were evaluated preoperatively and postoperatively at 6 weeks, 3, 6, 12, 18, and 24 months. The hypothesis was that the TDR success rate was non-inferior to ACDF at 24 months. Results Overall success rates were 73.6% for TDR and 65.3% for ACDF, confirming noninferiority (p < 0.0025). TDR demonstrated earlier improvements with significant differences in NDI scores at 6 weeks and 3 months, and VAS neck pain and SF-12 PCS scores at 6 weeks (p<0.05). Operative level range of motion in the TDR group was maintained throughout follow-up. Radiographic evidence of inferior adjacent segment degeneration was significantly greater with ACDF at 12 and 24 months (p < 0.05). AE rates were similar. Conclusions Mobi-C TDR is a safe and effective treatment for single-level disc degeneration, producing outcomes similar to ACDF with less adjacent segment degeneration. Level of Evidence: Level I. Clinical relevance: This study adds to the literature supporting cervical TDR as a viable option to ACDF in appropriately selected patients with disc degeneration.

Original languageEnglish (US)
Article number7
JournalInternational Journal of Spine Surgery
Volume8
DOIs
StatePublished - 2014

Fingerprint

Total Disc Replacement
Diskectomy
Spine
Clinical Trials
Equipment and Supplies
Intervertebral Disc Degeneration
Therapeutics
Neck Pain
Articular Range of Motion
Visual Analog Scale
Neck
Outcome Assessment (Health Care)
United States Food and Drug Administration
Patient Satisfaction
Arm

Keywords

  • Anterior cervical fusion
  • Cervical Spine
  • Clinical outcome
  • Randomized study
  • Total disc replacement

ASJC Scopus subject areas

  • Surgery
  • Orthopedics and Sports Medicine

Cite this

Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing mobi-C cervical artificial disc to anterior discectomy and fusion in the treatment of symptomatic degenerative disc disease in the cervical spine. / Hisey, Michael S.; Bae, Hyun W.; Davis, Reginald; Gaede, Steven; Hoffman, Greg; Kim, Kee D; Nunley, Pierce D.; Peterson, Daniel; Rashbaum, Ralph; Stokes, John.

In: International Journal of Spine Surgery, Vol. 8, 7, 2014.

Research output: Contribution to journalArticle

@article{abb6764efd0d46feb2f3d9cc35940edf,
title = "Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing mobi-C cervical artificial disc to anterior discectomy and fusion in the treatment of symptomatic degenerative disc disease in the cervical spine",
abstract = "Background Anterior cervical discectomy and fusion (ACDF) is the gold standard for treating symptomatic cervical disc degeneration. Cervical total disc replacements (TDRs) have emerged as an alternative for some patients. The purpose of this study was to evaluate the safety and effectiveness of a new TDR device compared with ACDF for treating singlelevel cervical disc degeneration. Methods This was a prospective, randomized, controlled, multicenter Food and Drug Administration (FDA) regulated Investigational Device Exemption (IDE) study. A total of 245 patients were treated (164 TDR: 81 ACDF). The primary outcome measure was overall success based on improvement in Neck Disability Index (NDI), no subsequent surgical interventions, and no adverse events (AEs) classified as major complications. Secondary outcome measures included SF-12, visual analog scale (VAS) assessing neck and arm pain, patient satisfaction, radiographic range of motion, and adjacent level degeneration. Patients were evaluated preoperatively and postoperatively at 6 weeks, 3, 6, 12, 18, and 24 months. The hypothesis was that the TDR success rate was non-inferior to ACDF at 24 months. Results Overall success rates were 73.6{\%} for TDR and 65.3{\%} for ACDF, confirming noninferiority (p < 0.0025). TDR demonstrated earlier improvements with significant differences in NDI scores at 6 weeks and 3 months, and VAS neck pain and SF-12 PCS scores at 6 weeks (p<0.05). Operative level range of motion in the TDR group was maintained throughout follow-up. Radiographic evidence of inferior adjacent segment degeneration was significantly greater with ACDF at 12 and 24 months (p < 0.05). AE rates were similar. Conclusions Mobi-C TDR is a safe and effective treatment for single-level disc degeneration, producing outcomes similar to ACDF with less adjacent segment degeneration. Level of Evidence: Level I. Clinical relevance: This study adds to the literature supporting cervical TDR as a viable option to ACDF in appropriately selected patients with disc degeneration.",
keywords = "Anterior cervical fusion, Cervical Spine, Clinical outcome, Randomized study, Total disc replacement",
author = "Hisey, {Michael S.} and Bae, {Hyun W.} and Reginald Davis and Steven Gaede and Greg Hoffman and Kim, {Kee D} and Nunley, {Pierce D.} and Daniel Peterson and Ralph Rashbaum and John Stokes",
year = "2014",
doi = "10.14444/1007",
language = "English (US)",
volume = "8",
journal = "International Journal of Spine Surgery",
issn = "2211-4599",
publisher = "Elsevier USA",

}

TY - JOUR

T1 - Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing mobi-C cervical artificial disc to anterior discectomy and fusion in the treatment of symptomatic degenerative disc disease in the cervical spine

AU - Hisey, Michael S.

AU - Bae, Hyun W.

AU - Davis, Reginald

AU - Gaede, Steven

AU - Hoffman, Greg

AU - Kim, Kee D

AU - Nunley, Pierce D.

AU - Peterson, Daniel

AU - Rashbaum, Ralph

AU - Stokes, John

PY - 2014

Y1 - 2014

N2 - Background Anterior cervical discectomy and fusion (ACDF) is the gold standard for treating symptomatic cervical disc degeneration. Cervical total disc replacements (TDRs) have emerged as an alternative for some patients. The purpose of this study was to evaluate the safety and effectiveness of a new TDR device compared with ACDF for treating singlelevel cervical disc degeneration. Methods This was a prospective, randomized, controlled, multicenter Food and Drug Administration (FDA) regulated Investigational Device Exemption (IDE) study. A total of 245 patients were treated (164 TDR: 81 ACDF). The primary outcome measure was overall success based on improvement in Neck Disability Index (NDI), no subsequent surgical interventions, and no adverse events (AEs) classified as major complications. Secondary outcome measures included SF-12, visual analog scale (VAS) assessing neck and arm pain, patient satisfaction, radiographic range of motion, and adjacent level degeneration. Patients were evaluated preoperatively and postoperatively at 6 weeks, 3, 6, 12, 18, and 24 months. The hypothesis was that the TDR success rate was non-inferior to ACDF at 24 months. Results Overall success rates were 73.6% for TDR and 65.3% for ACDF, confirming noninferiority (p < 0.0025). TDR demonstrated earlier improvements with significant differences in NDI scores at 6 weeks and 3 months, and VAS neck pain and SF-12 PCS scores at 6 weeks (p<0.05). Operative level range of motion in the TDR group was maintained throughout follow-up. Radiographic evidence of inferior adjacent segment degeneration was significantly greater with ACDF at 12 and 24 months (p < 0.05). AE rates were similar. Conclusions Mobi-C TDR is a safe and effective treatment for single-level disc degeneration, producing outcomes similar to ACDF with less adjacent segment degeneration. Level of Evidence: Level I. Clinical relevance: This study adds to the literature supporting cervical TDR as a viable option to ACDF in appropriately selected patients with disc degeneration.

AB - Background Anterior cervical discectomy and fusion (ACDF) is the gold standard for treating symptomatic cervical disc degeneration. Cervical total disc replacements (TDRs) have emerged as an alternative for some patients. The purpose of this study was to evaluate the safety and effectiveness of a new TDR device compared with ACDF for treating singlelevel cervical disc degeneration. Methods This was a prospective, randomized, controlled, multicenter Food and Drug Administration (FDA) regulated Investigational Device Exemption (IDE) study. A total of 245 patients were treated (164 TDR: 81 ACDF). The primary outcome measure was overall success based on improvement in Neck Disability Index (NDI), no subsequent surgical interventions, and no adverse events (AEs) classified as major complications. Secondary outcome measures included SF-12, visual analog scale (VAS) assessing neck and arm pain, patient satisfaction, radiographic range of motion, and adjacent level degeneration. Patients were evaluated preoperatively and postoperatively at 6 weeks, 3, 6, 12, 18, and 24 months. The hypothesis was that the TDR success rate was non-inferior to ACDF at 24 months. Results Overall success rates were 73.6% for TDR and 65.3% for ACDF, confirming noninferiority (p < 0.0025). TDR demonstrated earlier improvements with significant differences in NDI scores at 6 weeks and 3 months, and VAS neck pain and SF-12 PCS scores at 6 weeks (p<0.05). Operative level range of motion in the TDR group was maintained throughout follow-up. Radiographic evidence of inferior adjacent segment degeneration was significantly greater with ACDF at 12 and 24 months (p < 0.05). AE rates were similar. Conclusions Mobi-C TDR is a safe and effective treatment for single-level disc degeneration, producing outcomes similar to ACDF with less adjacent segment degeneration. Level of Evidence: Level I. Clinical relevance: This study adds to the literature supporting cervical TDR as a viable option to ACDF in appropriately selected patients with disc degeneration.

KW - Anterior cervical fusion

KW - Cervical Spine

KW - Clinical outcome

KW - Randomized study

KW - Total disc replacement

UR - http://www.scopus.com/inward/record.url?scp=84974711986&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84974711986&partnerID=8YFLogxK

U2 - 10.14444/1007

DO - 10.14444/1007

M3 - Article

VL - 8

JO - International Journal of Spine Surgery

JF - International Journal of Spine Surgery

SN - 2211-4599

M1 - 7

ER -