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

Spine (Phila Pa 1976). 2013 Feb 1;38(3):203-9. doi: 10.1097/BRS.0b013e318278eb38.

Abstract

Study design: 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).

Summary of background data: 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%).

Conclusion: 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.

Trial registration: ClinicalTrials.gov NCT00291018.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cervical Vertebrae / physiopathology
  • Cervical Vertebrae / surgery*
  • Disability Evaluation
  • Diskectomy / methods*
  • Female
  • Follow-Up Studies
  • Humans
  • Intervertebral Disc / pathology
  • Intervertebral Disc / physiopathology
  • Intervertebral Disc / surgery
  • Intervertebral Disc Degeneration / physiopathology
  • Intervertebral Disc Degeneration / surgery*
  • Male
  • Middle Aged
  • Pain Measurement
  • Patient Satisfaction
  • Prospective Studies
  • Prostheses and Implants
  • Range of Motion, Articular
  • Reoperation / statistics & numerical data
  • Spinal Fusion / methods*
  • Surveys and Questionnaires
  • Time Factors
  • Total Disc Replacement / methods*
  • Treatment Outcome
  • United States
  • United States Food and Drug Administration

Associated data

  • ClinicalTrials.gov/NCT00291018