Abstract
Introduction There is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C® with ACDF at 5-year follow-up. Methods This prospective, randomized, controlled trial was conducted as a Food and Drug Administration regulated Investigational Device Exemption trial across 23 centers with 245 patients randomized (2:1) to receive TDR with Mobi-C® Cervical Disc Prosthesis or ACDF with anterior plate and allograft. Outcome assessments included a composite overall success score, Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form-12 (SF-12) health survey, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent segment degeneration. Results The 60-month follow-up rate was 85.5% for the TDR group and 78.9% for the ACDF group. The composite overall success was 61.9% with TDR vs. 52.2% with ACDF, demonstrating statistical non-inferiority. Improvements in NDI, VAS neck and arm pain, and SF-12 scores were similar between groups and were maintained from earlier follow-up through 60 months. There was no significant difference between TDR and ACDF in adverse events or major complications. Range of motion was maintained with TDR through 60 months. Device-related subsequent surgeries (TDR: 3.0%, ACDF: 11.1%, p < 0.02) and adjacent segment degeneration at the superior level (TDR: 37.1%, ACDF: 54.7%, p < 0.03) were significantly lower for TDR patients. Conclusions Five-year results demonstrate the safety and efficacy of TDR with the Mobi-C as a viable alternative to ACDF with the potential advantage of lower rates of reoperation and adjacent segment degeneration, in the treatment of onelevel symptomatic cervical degenerative disc disease.
| Original language | English (US) |
|---|---|
| Article number | 10 |
| Journal | International Journal of Spine Surgery |
| Volume | 10 |
| DOIs | |
| State | Published - 2015 |
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Keywords
- Anterior cervical fusion
- Artificial disc
- Cervical arthroplasty
- Cervical spine
- Clinical outcome
- Degenerative disc disease
- Mobi-C® cervical disc prosthesis
- Randomized trial
- Total disc replacement
ASJC Scopus subject areas
- Surgery
- Orthopedics and Sports Medicine
Cite this
Prospective, randomized comparison of one-level Mobi-C cervical total disc replacement vs. anterior cervical discectomy and fusion : Results at 5-year follow-up. / Hisey, Michael S.; Zigler, Jack E.; Jackson, Robert; Nunley, Pierce D.; Bae, Hyun W.; Kim, Kee D; Ohnmeiss, Donna D.
In: International Journal of Spine Surgery, Vol. 10, 10, 2015.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Prospective, randomized comparison of one-level Mobi-C cervical total disc replacement vs. anterior cervical discectomy and fusion
T2 - Results at 5-year follow-up
AU - Hisey, Michael S.
AU - Zigler, Jack E.
AU - Jackson, Robert
AU - Nunley, Pierce D.
AU - Bae, Hyun W.
AU - Kim, Kee D
AU - Ohnmeiss, Donna D.
PY - 2015
Y1 - 2015
N2 - Introduction There is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C® with ACDF at 5-year follow-up. Methods This prospective, randomized, controlled trial was conducted as a Food and Drug Administration regulated Investigational Device Exemption trial across 23 centers with 245 patients randomized (2:1) to receive TDR with Mobi-C® Cervical Disc Prosthesis or ACDF with anterior plate and allograft. Outcome assessments included a composite overall success score, Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form-12 (SF-12) health survey, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent segment degeneration. Results The 60-month follow-up rate was 85.5% for the TDR group and 78.9% for the ACDF group. The composite overall success was 61.9% with TDR vs. 52.2% with ACDF, demonstrating statistical non-inferiority. Improvements in NDI, VAS neck and arm pain, and SF-12 scores were similar between groups and were maintained from earlier follow-up through 60 months. There was no significant difference between TDR and ACDF in adverse events or major complications. Range of motion was maintained with TDR through 60 months. Device-related subsequent surgeries (TDR: 3.0%, ACDF: 11.1%, p < 0.02) and adjacent segment degeneration at the superior level (TDR: 37.1%, ACDF: 54.7%, p < 0.03) were significantly lower for TDR patients. Conclusions Five-year results demonstrate the safety and efficacy of TDR with the Mobi-C as a viable alternative to ACDF with the potential advantage of lower rates of reoperation and adjacent segment degeneration, in the treatment of onelevel symptomatic cervical degenerative disc disease.
AB - Introduction There is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C® with ACDF at 5-year follow-up. Methods This prospective, randomized, controlled trial was conducted as a Food and Drug Administration regulated Investigational Device Exemption trial across 23 centers with 245 patients randomized (2:1) to receive TDR with Mobi-C® Cervical Disc Prosthesis or ACDF with anterior plate and allograft. Outcome assessments included a composite overall success score, Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form-12 (SF-12) health survey, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent segment degeneration. Results The 60-month follow-up rate was 85.5% for the TDR group and 78.9% for the ACDF group. The composite overall success was 61.9% with TDR vs. 52.2% with ACDF, demonstrating statistical non-inferiority. Improvements in NDI, VAS neck and arm pain, and SF-12 scores were similar between groups and were maintained from earlier follow-up through 60 months. There was no significant difference between TDR and ACDF in adverse events or major complications. Range of motion was maintained with TDR through 60 months. Device-related subsequent surgeries (TDR: 3.0%, ACDF: 11.1%, p < 0.02) and adjacent segment degeneration at the superior level (TDR: 37.1%, ACDF: 54.7%, p < 0.03) were significantly lower for TDR patients. Conclusions Five-year results demonstrate the safety and efficacy of TDR with the Mobi-C as a viable alternative to ACDF with the potential advantage of lower rates of reoperation and adjacent segment degeneration, in the treatment of onelevel symptomatic cervical degenerative disc disease.
KW - Anterior cervical fusion
KW - Artificial disc
KW - Cervical arthroplasty
KW - Cervical spine
KW - Clinical outcome
KW - Degenerative disc disease
KW - Mobi-C® cervical disc prosthesis
KW - Randomized trial
KW - Total disc replacement
UR - http://www.scopus.com/inward/record.url?scp=84975740686&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84975740686&partnerID=8YFLogxK
U2 - 10.14444/3010
DO - 10.14444/3010
M3 - Article
VL - 10
JO - International Journal of Spine Surgery
JF - International Journal of Spine Surgery
SN - 2211-4599
M1 - 10
ER -