Comparison of clinical outcomes of 1-and 2-level total disc replacement

Four-year results from a prospective, randomized, controlled, multicenter IDE clinical trial

Hyun W. Bae, Kee D Kim, Pierce Dalton Nunley, Robert J. Jackson, Michael S. Hisey, Reginald J. Davis, Gregory A. Hoffman, Steven E. Gaede, Guy O. Danielson, Daniel L. Peterson, John M. Stokes, Ali Araghi

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Study Design. A prospective, randomized, multicenter Food and Drug Administration Investigation Device Exemption study using total disc replacement as surgical treatment of degenerative disc disease at 1 or 2 contiguous levels of the cervical spine. Objective. To evaluate the safety and effectiveness of total disc replacement at single or 2 contiguous levels through 48 months of follow-up. Summary of Background Data. Cervical total disc replacement has been shown to be a safe and effective alternative to anterior cervical discectomy and fusion at 24 months. Its motion-preserving capabilities may avoid accelerating adjacent segment pathology and thereby lower the rate of associated complications. Methods. Patients were randomized in a 2:1 ratio (total disc replacement [TDR]: anterior cervical discectomy and fusion [ACDF]) at 24 sites. Ultimately, 164 patients received TDR at 1 level and 225 patients received TDR at 2 contiguous levels. An additional 24 patients (15 one-level, 9 two-level) were treated with TDR as training cases. Outcome measures included neck disability index, visual analogue scale neck and arm pain, Short Form 12-item Health Survey (SF-12) Mental Composite Score (MCS) and Physical Composite Score (PCS), range of motion, major complication rates, and secondary surgery rates. Patients received follow-up examinations at regular intervals through 4 years after surgery. Results. Preoperative characteristics were statistically similar for the 1-and 2-level patient groups. Four-year follow-up rates were 83.1% (1-level) and 89.0% (2-level). There was no statistically significant difference between 1-and 2-level TDR groups for all clinical outcome measures. Both TDR groups experienced significant improvement at each follow-up when compared with preoperative scores. One case of migration was reported in the 2-level TDR group. Conclusion. A 4-year post hoc comparison of 1-and 2-level TDR patients concurrently enrolled in a 24-center, Food and Drug Administration Investigation Device Exemption clinical trial indicated no statistical differences between groups in clinical outcomes, overall complication rates, and subsequent surgery rates.

Original languageEnglish (US)
Pages (from-to)759-766
Number of pages8
JournalSpine
Volume40
Issue number11
DOIs
StatePublished - 2015

Fingerprint

Total Disc Replacement
Clinical Trials
Diskectomy
United States Food and Drug Administration
Outcome Assessment (Health Care)
Equipment and Supplies
Neck Pain
Articular Range of Motion
Health Surveys
Visual Analog Scale

Keywords

  • Anterior cervical discectomy and fusion
  • Artificial disc
  • Degenerative disc disease
  • Mobi-C Cervical Artificial Disc
  • Multilevel
  • Total disc replacement

ASJC Scopus subject areas

  • Clinical Neurology
  • Orthopedics and Sports Medicine

Cite this

Comparison of clinical outcomes of 1-and 2-level total disc replacement : Four-year results from a prospective, randomized, controlled, multicenter IDE clinical trial. / Bae, Hyun W.; Kim, Kee D; Nunley, Pierce Dalton; Jackson, Robert J.; Hisey, Michael S.; Davis, Reginald J.; Hoffman, Gregory A.; Gaede, Steven E.; Danielson, Guy O.; Peterson, Daniel L.; Stokes, John M.; Araghi, Ali.

In: Spine, Vol. 40, No. 11, 2015, p. 759-766.

Research output: Contribution to journalArticle

Bae, HW, Kim, KD, Nunley, PD, Jackson, RJ, Hisey, MS, Davis, RJ, Hoffman, GA, Gaede, SE, Danielson, GO, Peterson, DL, Stokes, JM & Araghi, A 2015, 'Comparison of clinical outcomes of 1-and 2-level total disc replacement: Four-year results from a prospective, randomized, controlled, multicenter IDE clinical trial', Spine, vol. 40, no. 11, pp. 759-766. https://doi.org/10.1097/BRS.0000000000000887
Bae, Hyun W. ; Kim, Kee D ; Nunley, Pierce Dalton ; Jackson, Robert J. ; Hisey, Michael S. ; Davis, Reginald J. ; Hoffman, Gregory A. ; Gaede, Steven E. ; Danielson, Guy O. ; Peterson, Daniel L. ; Stokes, John M. ; Araghi, Ali. / Comparison of clinical outcomes of 1-and 2-level total disc replacement : Four-year results from a prospective, randomized, controlled, multicenter IDE clinical trial. In: Spine. 2015 ; Vol. 40, No. 11. pp. 759-766.
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title = "Comparison of clinical outcomes of 1-and 2-level total disc replacement: Four-year results from a prospective, randomized, controlled, multicenter IDE clinical trial",
abstract = "Study Design. A prospective, randomized, multicenter Food and Drug Administration Investigation Device Exemption study using total disc replacement as surgical treatment of degenerative disc disease at 1 or 2 contiguous levels of the cervical spine. Objective. To evaluate the safety and effectiveness of total disc replacement at single or 2 contiguous levels through 48 months of follow-up. Summary of Background Data. Cervical total disc replacement has been shown to be a safe and effective alternative to anterior cervical discectomy and fusion at 24 months. Its motion-preserving capabilities may avoid accelerating adjacent segment pathology and thereby lower the rate of associated complications. Methods. Patients were randomized in a 2:1 ratio (total disc replacement [TDR]: anterior cervical discectomy and fusion [ACDF]) at 24 sites. Ultimately, 164 patients received TDR at 1 level and 225 patients received TDR at 2 contiguous levels. An additional 24 patients (15 one-level, 9 two-level) were treated with TDR as training cases. Outcome measures included neck disability index, visual analogue scale neck and arm pain, Short Form 12-item Health Survey (SF-12) Mental Composite Score (MCS) and Physical Composite Score (PCS), range of motion, major complication rates, and secondary surgery rates. Patients received follow-up examinations at regular intervals through 4 years after surgery. Results. Preoperative characteristics were statistically similar for the 1-and 2-level patient groups. Four-year follow-up rates were 83.1{\%} (1-level) and 89.0{\%} (2-level). There was no statistically significant difference between 1-and 2-level TDR groups for all clinical outcome measures. Both TDR groups experienced significant improvement at each follow-up when compared with preoperative scores. One case of migration was reported in the 2-level TDR group. Conclusion. A 4-year post hoc comparison of 1-and 2-level TDR patients concurrently enrolled in a 24-center, Food and Drug Administration Investigation Device Exemption clinical trial indicated no statistical differences between groups in clinical outcomes, overall complication rates, and subsequent surgery rates.",
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author = "Bae, {Hyun W.} and Kim, {Kee D} and Nunley, {Pierce Dalton} and Jackson, {Robert J.} and Hisey, {Michael S.} and Davis, {Reginald J.} and Hoffman, {Gregory A.} and Gaede, {Steven E.} and Danielson, {Guy O.} and Peterson, {Daniel L.} and Stokes, {John M.} and Ali Araghi",
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T2 - Four-year results from a prospective, randomized, controlled, multicenter IDE clinical trial

AU - Bae, Hyun W.

AU - Kim, Kee D

AU - Nunley, Pierce Dalton

AU - Jackson, Robert J.

AU - Hisey, Michael S.

AU - Davis, Reginald J.

AU - Hoffman, Gregory A.

AU - Gaede, Steven E.

AU - Danielson, Guy O.

AU - Peterson, Daniel L.

AU - Stokes, John M.

AU - Araghi, Ali

PY - 2015

Y1 - 2015

N2 - Study Design. A prospective, randomized, multicenter Food and Drug Administration Investigation Device Exemption study using total disc replacement as surgical treatment of degenerative disc disease at 1 or 2 contiguous levels of the cervical spine. Objective. To evaluate the safety and effectiveness of total disc replacement at single or 2 contiguous levels through 48 months of follow-up. Summary of Background Data. Cervical total disc replacement has been shown to be a safe and effective alternative to anterior cervical discectomy and fusion at 24 months. Its motion-preserving capabilities may avoid accelerating adjacent segment pathology and thereby lower the rate of associated complications. Methods. Patients were randomized in a 2:1 ratio (total disc replacement [TDR]: anterior cervical discectomy and fusion [ACDF]) at 24 sites. Ultimately, 164 patients received TDR at 1 level and 225 patients received TDR at 2 contiguous levels. An additional 24 patients (15 one-level, 9 two-level) were treated with TDR as training cases. Outcome measures included neck disability index, visual analogue scale neck and arm pain, Short Form 12-item Health Survey (SF-12) Mental Composite Score (MCS) and Physical Composite Score (PCS), range of motion, major complication rates, and secondary surgery rates. Patients received follow-up examinations at regular intervals through 4 years after surgery. Results. Preoperative characteristics were statistically similar for the 1-and 2-level patient groups. Four-year follow-up rates were 83.1% (1-level) and 89.0% (2-level). There was no statistically significant difference between 1-and 2-level TDR groups for all clinical outcome measures. Both TDR groups experienced significant improvement at each follow-up when compared with preoperative scores. One case of migration was reported in the 2-level TDR group. Conclusion. A 4-year post hoc comparison of 1-and 2-level TDR patients concurrently enrolled in a 24-center, Food and Drug Administration Investigation Device Exemption clinical trial indicated no statistical differences between groups in clinical outcomes, overall complication rates, and subsequent surgery rates.

AB - Study Design. A prospective, randomized, multicenter Food and Drug Administration Investigation Device Exemption study using total disc replacement as surgical treatment of degenerative disc disease at 1 or 2 contiguous levels of the cervical spine. Objective. To evaluate the safety and effectiveness of total disc replacement at single or 2 contiguous levels through 48 months of follow-up. Summary of Background Data. Cervical total disc replacement has been shown to be a safe and effective alternative to anterior cervical discectomy and fusion at 24 months. Its motion-preserving capabilities may avoid accelerating adjacent segment pathology and thereby lower the rate of associated complications. Methods. Patients were randomized in a 2:1 ratio (total disc replacement [TDR]: anterior cervical discectomy and fusion [ACDF]) at 24 sites. Ultimately, 164 patients received TDR at 1 level and 225 patients received TDR at 2 contiguous levels. An additional 24 patients (15 one-level, 9 two-level) were treated with TDR as training cases. Outcome measures included neck disability index, visual analogue scale neck and arm pain, Short Form 12-item Health Survey (SF-12) Mental Composite Score (MCS) and Physical Composite Score (PCS), range of motion, major complication rates, and secondary surgery rates. Patients received follow-up examinations at regular intervals through 4 years after surgery. Results. Preoperative characteristics were statistically similar for the 1-and 2-level patient groups. Four-year follow-up rates were 83.1% (1-level) and 89.0% (2-level). There was no statistically significant difference between 1-and 2-level TDR groups for all clinical outcome measures. Both TDR groups experienced significant improvement at each follow-up when compared with preoperative scores. One case of migration was reported in the 2-level TDR group. Conclusion. A 4-year post hoc comparison of 1-and 2-level TDR patients concurrently enrolled in a 24-center, Food and Drug Administration Investigation Device Exemption clinical trial indicated no statistical differences between groups in clinical outcomes, overall complication rates, and subsequent surgery rates.

KW - Anterior cervical discectomy and fusion

KW - Artificial disc

KW - Degenerative disc disease

KW - Mobi-C Cervical Artificial Disc

KW - Multilevel

KW - Total disc replacement

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