Symptomatic Adjacent Level Disease Requiring Surgery

Analysis of 10-Year Results From a Prospective, Randomized, Clinical Trial Comparing Cervical Disc Arthroplasty to Anterior Cervical Fusion

George M. Ghobrial, William F. Lavelle, Jeffrey E. Florman, K. Daniel Riew, Allan D Levi

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

BACKGROUND: Ten-year follow-up data from the US Food and Drug Administration investigational device exemption trial comparing BRYAN® Cervical Disc (Medtronic, Dublin, Ireland) arthroplasty to anterior cervical discectomy and fusion (ACDF) demonstrated that disc arthroplasty maintained range of motion and improvements in overall success and neck disability. OBJECTIVE: To compare the 10-yr rates of symptomatic adjacent level disease requiring surgery (SALDRS). METHODS: Prospective randomized trial data were analyzed comparing BRYAN® Cervical Disc arthroplasty to ACDF for single-level cervical disc disease with concordant radiculopathy or myelopathy with clinicoradiographic analysis at 10 yr. Secondarily, 84-mo data were pooled with PRESTIGE® Cervical Disc arthroplasty (Medtronic) study data to provide overall rates of SALDRS. RESULTS: Significantly greater overall success was maintained at every postoperative interval with an overall success rate of 81.3% with BRYAN® disc and 66.3% with ACDF (P = .005) without loss of motion preservation (8.69° vs 0.60°). Reoperation at adjacent levels up to the 120-mo visit was 9.7% in the arthroplasty group and 15.8% in the ACDF group (P = .146). The combined data from BRYAN® and Prestige ST demonstrate that BRYAN® and Prestige disc groups had a lower rate of second surgeries at the adjacent levels, up to the 84-mo visit, compared to the combined ACDF groups (6.9% vs 11.7%; P = .023). CONCLUSION: Compared with ACDF, fewer patients with the BRYAN® disc required surgery for symptomatic adjacent level degeneration, but this did not achieve statistical significance. Analysis of combined study data using Bryan and Prestige discs shows significant differences in SADLRS as early as 7 yr.

Original languageEnglish (US)
Pages (from-to)347-354
Number of pages8
JournalNeurosurgery
Volume84
Issue number2
DOIs
StatePublished - Feb 1 2019

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Diskectomy
Arthroplasty
Randomized Controlled Trials
Radiculopathy
Spinal Cord Diseases
United States Food and Drug Administration
Articular Range of Motion
Reoperation
Ireland
Neck
Equipment and Supplies

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

Cite this

Symptomatic Adjacent Level Disease Requiring Surgery : Analysis of 10-Year Results From a Prospective, Randomized, Clinical Trial Comparing Cervical Disc Arthroplasty to Anterior Cervical Fusion. / Ghobrial, George M.; Lavelle, William F.; Florman, Jeffrey E.; Riew, K. Daniel; Levi, Allan D.

In: Neurosurgery, Vol. 84, No. 2, 01.02.2019, p. 347-354.

Research output: Contribution to journalArticle

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abstract = "BACKGROUND: Ten-year follow-up data from the US Food and Drug Administration investigational device exemption trial comparing BRYAN{\circledR} Cervical Disc (Medtronic, Dublin, Ireland) arthroplasty to anterior cervical discectomy and fusion (ACDF) demonstrated that disc arthroplasty maintained range of motion and improvements in overall success and neck disability. OBJECTIVE: To compare the 10-yr rates of symptomatic adjacent level disease requiring surgery (SALDRS). METHODS: Prospective randomized trial data were analyzed comparing BRYAN{\circledR} Cervical Disc arthroplasty to ACDF for single-level cervical disc disease with concordant radiculopathy or myelopathy with clinicoradiographic analysis at 10 yr. Secondarily, 84-mo data were pooled with PRESTIGE{\circledR} Cervical Disc arthroplasty (Medtronic) study data to provide overall rates of SALDRS. RESULTS: Significantly greater overall success was maintained at every postoperative interval with an overall success rate of 81.3{\%} with BRYAN{\circledR} disc and 66.3{\%} with ACDF (P = .005) without loss of motion preservation (8.69° vs 0.60°). Reoperation at adjacent levels up to the 120-mo visit was 9.7{\%} in the arthroplasty group and 15.8{\%} in the ACDF group (P = .146). The combined data from BRYAN{\circledR} and Prestige ST demonstrate that BRYAN{\circledR} and Prestige disc groups had a lower rate of second surgeries at the adjacent levels, up to the 84-mo visit, compared to the combined ACDF groups (6.9{\%} vs 11.7{\%}; P = .023). CONCLUSION: Compared with ACDF, fewer patients with the BRYAN{\circledR} disc required surgery for symptomatic adjacent level degeneration, but this did not achieve statistical significance. Analysis of combined study data using Bryan and Prestige discs shows significant differences in SADLRS as early as 7 yr.",
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AU - Lavelle, William F.

AU - Florman, Jeffrey E.

AU - Riew, K. Daniel

AU - Levi, Allan D

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N2 - BACKGROUND: Ten-year follow-up data from the US Food and Drug Administration investigational device exemption trial comparing BRYAN® Cervical Disc (Medtronic, Dublin, Ireland) arthroplasty to anterior cervical discectomy and fusion (ACDF) demonstrated that disc arthroplasty maintained range of motion and improvements in overall success and neck disability. OBJECTIVE: To compare the 10-yr rates of symptomatic adjacent level disease requiring surgery (SALDRS). METHODS: Prospective randomized trial data were analyzed comparing BRYAN® Cervical Disc arthroplasty to ACDF for single-level cervical disc disease with concordant radiculopathy or myelopathy with clinicoradiographic analysis at 10 yr. Secondarily, 84-mo data were pooled with PRESTIGE® Cervical Disc arthroplasty (Medtronic) study data to provide overall rates of SALDRS. RESULTS: Significantly greater overall success was maintained at every postoperative interval with an overall success rate of 81.3% with BRYAN® disc and 66.3% with ACDF (P = .005) without loss of motion preservation (8.69° vs 0.60°). Reoperation at adjacent levels up to the 120-mo visit was 9.7% in the arthroplasty group and 15.8% in the ACDF group (P = .146). The combined data from BRYAN® and Prestige ST demonstrate that BRYAN® and Prestige disc groups had a lower rate of second surgeries at the adjacent levels, up to the 84-mo visit, compared to the combined ACDF groups (6.9% vs 11.7%; P = .023). CONCLUSION: Compared with ACDF, fewer patients with the BRYAN® disc required surgery for symptomatic adjacent level degeneration, but this did not achieve statistical significance. Analysis of combined study data using Bryan and Prestige discs shows significant differences in SADLRS as early as 7 yr.

AB - BACKGROUND: Ten-year follow-up data from the US Food and Drug Administration investigational device exemption trial comparing BRYAN® Cervical Disc (Medtronic, Dublin, Ireland) arthroplasty to anterior cervical discectomy and fusion (ACDF) demonstrated that disc arthroplasty maintained range of motion and improvements in overall success and neck disability. OBJECTIVE: To compare the 10-yr rates of symptomatic adjacent level disease requiring surgery (SALDRS). METHODS: Prospective randomized trial data were analyzed comparing BRYAN® Cervical Disc arthroplasty to ACDF for single-level cervical disc disease with concordant radiculopathy or myelopathy with clinicoradiographic analysis at 10 yr. Secondarily, 84-mo data were pooled with PRESTIGE® Cervical Disc arthroplasty (Medtronic) study data to provide overall rates of SALDRS. RESULTS: Significantly greater overall success was maintained at every postoperative interval with an overall success rate of 81.3% with BRYAN® disc and 66.3% with ACDF (P = .005) without loss of motion preservation (8.69° vs 0.60°). Reoperation at adjacent levels up to the 120-mo visit was 9.7% in the arthroplasty group and 15.8% in the ACDF group (P = .146). The combined data from BRYAN® and Prestige ST demonstrate that BRYAN® and Prestige disc groups had a lower rate of second surgeries at the adjacent levels, up to the 84-mo visit, compared to the combined ACDF groups (6.9% vs 11.7%; P = .023). CONCLUSION: Compared with ACDF, fewer patients with the BRYAN® disc required surgery for symptomatic adjacent level degeneration, but this did not achieve statistical significance. Analysis of combined study data using Bryan and Prestige discs shows significant differences in SADLRS as early as 7 yr.

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