ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study.
METHODS
Randomized controlled trial.


OBJECTIVE
Analyze the clinical outcomes at 5 years comparing cervical total disc replacement (TDR) with ProDisc-C (Synthes Spine USA Products; LLC, West Chester, PA) with anterior cervical discectomy and fusion (ACDF).


BACKGROUND
Previous reports of 2- and 4-year results have shown that ProDisc-C, a TDR for surgical treatment of patients experiencing single-level symptomatic cervical disc disease between C3 and C7, is safe and effective.


METHODS
Two hundred nine patients (103 ProDisc-C and 106 ACDF) from 13 sites were randomized and treated. Results including neck disability index, visual analog scale (VAS) neck and arm pain, Short Form-36 (SF-36), neurological examination, device success, adverse event occurrence, and VAS patient satisfaction were analyzed.


RESULTS
Demographics were similar between the 2 patient groups (ProDisc-C: 42.1 ± 8.4 yr, 44.7% males; ACDF: 43.5 ± 7.1 yr, 46.2% males). Rates of follow-up at 2 years were 98.1% ProDisc-C and 94.8% ACDF, and at 5 years 72.7% ProDisc-C and 63.5% ACDF. For all clinical outcomes for both groups, there was a statistically and clinically significant improvement at 2 and 5 years compared with baseline. At 5 years, ProDisc-C patients had statistically significantly less neck pain intensity and frequency. Both groups scored high VAS satisfaction scores at 5 years, with ProDisc-C 86.56 and ACDF 82.74. There were no reports of device failures or implant migration with ProDisc-C. The ProDisc-C patients maintained motion at their index level. At 5 years, the ProDisc-C patients had a statistically significantly lower rate of reoperation compared with ACDF patients (2.9% vs. 11.3%).


CONCLUSIONS
Five-year results show that TDR with ProDisc-C is a safe and effective treatment of single-level symptomatic cervical disc disease. Clinical outcomes were comparable with ACDF. ProDisc-C patients maintained motion at the index level and had significantly less neck pain intensity and frequency as well as a lower probability of secondary surgery.
Texas Back Institute, Plano, TX 75093, USA. jackzigler@juno.com
Jack E
JE
Zigler
Rick
R
Delamarter
Dan
D
Murrey
Jeffrey
J
Spivak
Michael
M
Janssen
D000328:Adult; D002574:Cervical Vertebrae / Q000503:physiopathology / Q000601:surgery*; D004185:Disability Evaluation; D017586:Diskectomy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007403:Intervertebral Disc / Q000473:pathology / Q000503:physiopathology / Q000601:surgery; D055959:Intervertebral Disc Degeneration / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D017060:Patient Satisfaction; D011446:Prospective Studies; D019736:Prostheses and Implants; D016059:Range of Motion, Articular; D012086:Reoperation / Q000706:statistics & numerical data; D013123:Spinal Fusion / Q000379:methods*; D011795:Surveys and Questionnaires; D013997:Time Factors; D059145:Total Disc Replacement / Q000379:methods*; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration