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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 01; 38(3):203-9.S

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.

Links

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Authors+Show Affiliations

Zigler JE
Texas Back Institute, Plano, TX 75093, USA. jackzigler@juno.com
Delamarter R
No affiliation info available
Murrey D
No affiliation info available
Spivak J
No affiliation info available
Janssen M
No affiliation info available

MeSH

AdultCervical VertebraeDisability EvaluationDiskectomyFemaleFollow-Up StudiesHumansIntervertebral DiscIntervertebral Disc DegenerationMaleMiddle AgedPain MeasurementPatient SatisfactionProspective StudiesProstheses and ImplantsRange of Motion, ArticularReoperationSpinal FusionSurveys and QuestionnairesTime FactorsTotal Disc ReplacementTreatment OutcomeUnited StatesUnited States Food and Drug Administration

Pub Type(s)

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

Language

eng

PubMed ID

23080427

Clinical Trial Links

Clinical trial which this article describes
Clinical and Radiological Outcomes: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct.

Citation

Zigler, Jack E., et al. "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, vol. 38, no. 3, 2013, pp. 203-9.
Zigler JE, Delamarter R, Murrey D, et al. 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;38(3):203-9.
Zigler, J. E., Delamarter, R., Murrey, D., Spivak, J., & Janssen, M. (2013). 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, 38(3), 203-9. https://doi.org/10.1097/BRS.0b013e318278eb38
Zigler JE, et al. 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. PubMed PMID: 23080427.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Zigler,Jack E, AU - Delamarter,Rick, AU - Murrey,Dan, AU - Spivak,Jeffrey, AU - Janssen,Michael, PY - 2012/10/20/entrez PY - 2012/10/20/pubmed PY - 2013/7/20/medline SP - 203 EP - 9 JF - Spine JO - Spine (Phila Pa 1976) VL - 38 IS - 3 N2 - 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. SN - 1528-1159 UR - https://www.unboundmedicine.com/medline/citation/23080427/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_ L2 - https://doi.org/10.1097/BRS.0b013e318278eb38 DB - PRIME DP - Unbound Medicine ER -
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