Ten-year Outcomes of Cervical Disc Replacement With the BRYAN Cervical Disc: Results From a Prospective, Randomized, Controlled Clinical Trial

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

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

STUDY DESIGN: A prospective, randomized multicenter IDE trial between May 2002 and October 2004. OBJECTIVE: The aim of this study was to report on the 10-year safety and efficacy of BRYAN cervical disc arthroplasty (CDA). SUMMARY OF BACKGROUND DATA: Cervical disc arthroplasty (CDA) is a potential alternative for anterior cervical decompression and fusion (ACDF) with the hope that maintenance of motion may decrease the likelihood of adjacent segment disease. METHODS: This is an analysis of a US Food and Drug Administration (FDA) investigation comparing CDA with ACDF for single-level patients. Eligible patients were ≥ 21 years of age with symptomatic cervical disc disease who had failed conservative care. Patients were followed at regular intervals with the current data set at > 10 years. Protocol for overall success: ≥ 15-point improvement in NDI scores, maintenance or improvement in neurologic status, no serious adverse events related to implant or implant/surgical procedure, and no subsequent surgery or intervention classified as "failure." RESULTS: At 10-year follow-up, 128 (CDA) and 104 (ACDF) patients were available for evaluation. Overall success rate was significantly higher for CDA group (81.3% vs. 66.3%; P = 0.005). The rate of second surgeries at adjacent levels was lower for CDA group (9.7% vs. 15.8%; P = 0.146). NDI scores improved significantly in CDA group (Δ38.3 vs. Δ31.1; P = 0.010). Visual Analog Scale (VAS) neck and arm improved in the CDA group (Δ54.3 vs. Δ49.2; P = 0.119), (Δ58.1 vs. Δ51.6; P = 0.0.60) respectively. About 4.1% of CDA patients and 4.9% of ACDF patients had serious adverse events related to study device. Mean angular motions at index level for BRYAN disc and ACDF were 8.69° and 0.60°, respectively. CONCLUSION: CDA can preserve and maintain motion in the long term compared with ACDF. There was a trend toward fewer adjacent segment surgeries for BRYAN disc that did not reach significance. Significant improvement in CDA NDI scores may suggest better long-term success for CDA as compared to fusion.2.

Original languageEnglish (US)
Pages (from-to)601-608
Number of pages8
JournalSPINE
Volume44
Issue number9
DOIs
StatePublished - May 1 2019

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Arthroplasty
Randomized Controlled Trials
Decompression
Maintenance
United States Food and Drug Administration
Visual Analog Scale
Nervous System
Multicenter Studies
Arm
Neck
Safety
Equipment and Supplies

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine
  • Clinical Neurology

Cite this

Ten-year Outcomes of Cervical Disc Replacement With the BRYAN Cervical Disc : Results From a Prospective, Randomized, Controlled Clinical Trial. / Lavelle, William F.; Riew, K. Daniel; Levi, Allan D; Florman, Jeffrey E.

In: SPINE, Vol. 44, No. 9, 01.05.2019, p. 601-608.

Research output: Contribution to journalArticle

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title = "Ten-year Outcomes of Cervical Disc Replacement With the BRYAN Cervical Disc: Results From a Prospective, Randomized, Controlled Clinical Trial",
abstract = "STUDY DESIGN: A prospective, randomized multicenter IDE trial between May 2002 and October 2004. OBJECTIVE: The aim of this study was to report on the 10-year safety and efficacy of BRYAN cervical disc arthroplasty (CDA). SUMMARY OF BACKGROUND DATA: Cervical disc arthroplasty (CDA) is a potential alternative for anterior cervical decompression and fusion (ACDF) with the hope that maintenance of motion may decrease the likelihood of adjacent segment disease. METHODS: This is an analysis of a US Food and Drug Administration (FDA) investigation comparing CDA with ACDF for single-level patients. Eligible patients were ≥ 21 years of age with symptomatic cervical disc disease who had failed conservative care. Patients were followed at regular intervals with the current data set at > 10 years. Protocol for overall success: ≥ 15-point improvement in NDI scores, maintenance or improvement in neurologic status, no serious adverse events related to implant or implant/surgical procedure, and no subsequent surgery or intervention classified as {"}failure.{"} RESULTS: At 10-year follow-up, 128 (CDA) and 104 (ACDF) patients were available for evaluation. Overall success rate was significantly higher for CDA group (81.3{\%} vs. 66.3{\%}; P = 0.005). The rate of second surgeries at adjacent levels was lower for CDA group (9.7{\%} vs. 15.8{\%}; P = 0.146). NDI scores improved significantly in CDA group (Δ38.3 vs. Δ31.1; P = 0.010). Visual Analog Scale (VAS) neck and arm improved in the CDA group (Δ54.3 vs. Δ49.2; P = 0.119), (Δ58.1 vs. Δ51.6; P = 0.0.60) respectively. About 4.1{\%} of CDA patients and 4.9{\%} of ACDF patients had serious adverse events related to study device. Mean angular motions at index level for BRYAN disc and ACDF were 8.69° and 0.60°, respectively. CONCLUSION: CDA can preserve and maintain motion in the long term compared with ACDF. There was a trend toward fewer adjacent segment surgeries for BRYAN disc that did not reach significance. Significant improvement in CDA NDI scores may suggest better long-term success for CDA as compared to fusion.2.",
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T1 - Ten-year Outcomes of Cervical Disc Replacement With the BRYAN Cervical Disc

T2 - Results From a Prospective, Randomized, Controlled Clinical Trial

AU - Lavelle, William F.

AU - Riew, K. Daniel

AU - Levi, Allan D

AU - Florman, Jeffrey E.

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N2 - STUDY DESIGN: A prospective, randomized multicenter IDE trial between May 2002 and October 2004. OBJECTIVE: The aim of this study was to report on the 10-year safety and efficacy of BRYAN cervical disc arthroplasty (CDA). SUMMARY OF BACKGROUND DATA: Cervical disc arthroplasty (CDA) is a potential alternative for anterior cervical decompression and fusion (ACDF) with the hope that maintenance of motion may decrease the likelihood of adjacent segment disease. METHODS: This is an analysis of a US Food and Drug Administration (FDA) investigation comparing CDA with ACDF for single-level patients. Eligible patients were ≥ 21 years of age with symptomatic cervical disc disease who had failed conservative care. Patients were followed at regular intervals with the current data set at > 10 years. Protocol for overall success: ≥ 15-point improvement in NDI scores, maintenance or improvement in neurologic status, no serious adverse events related to implant or implant/surgical procedure, and no subsequent surgery or intervention classified as "failure." RESULTS: At 10-year follow-up, 128 (CDA) and 104 (ACDF) patients were available for evaluation. Overall success rate was significantly higher for CDA group (81.3% vs. 66.3%; P = 0.005). The rate of second surgeries at adjacent levels was lower for CDA group (9.7% vs. 15.8%; P = 0.146). NDI scores improved significantly in CDA group (Δ38.3 vs. Δ31.1; P = 0.010). Visual Analog Scale (VAS) neck and arm improved in the CDA group (Δ54.3 vs. Δ49.2; P = 0.119), (Δ58.1 vs. Δ51.6; P = 0.0.60) respectively. About 4.1% of CDA patients and 4.9% of ACDF patients had serious adverse events related to study device. Mean angular motions at index level for BRYAN disc and ACDF were 8.69° and 0.60°, respectively. CONCLUSION: CDA can preserve and maintain motion in the long term compared with ACDF. There was a trend toward fewer adjacent segment surgeries for BRYAN disc that did not reach significance. Significant improvement in CDA NDI scores may suggest better long-term success for CDA as compared to fusion.2.

AB - STUDY DESIGN: A prospective, randomized multicenter IDE trial between May 2002 and October 2004. OBJECTIVE: The aim of this study was to report on the 10-year safety and efficacy of BRYAN cervical disc arthroplasty (CDA). SUMMARY OF BACKGROUND DATA: Cervical disc arthroplasty (CDA) is a potential alternative for anterior cervical decompression and fusion (ACDF) with the hope that maintenance of motion may decrease the likelihood of adjacent segment disease. METHODS: This is an analysis of a US Food and Drug Administration (FDA) investigation comparing CDA with ACDF for single-level patients. Eligible patients were ≥ 21 years of age with symptomatic cervical disc disease who had failed conservative care. Patients were followed at regular intervals with the current data set at > 10 years. Protocol for overall success: ≥ 15-point improvement in NDI scores, maintenance or improvement in neurologic status, no serious adverse events related to implant or implant/surgical procedure, and no subsequent surgery or intervention classified as "failure." RESULTS: At 10-year follow-up, 128 (CDA) and 104 (ACDF) patients were available for evaluation. Overall success rate was significantly higher for CDA group (81.3% vs. 66.3%; P = 0.005). The rate of second surgeries at adjacent levels was lower for CDA group (9.7% vs. 15.8%; P = 0.146). NDI scores improved significantly in CDA group (Δ38.3 vs. Δ31.1; P = 0.010). Visual Analog Scale (VAS) neck and arm improved in the CDA group (Δ54.3 vs. Δ49.2; P = 0.119), (Δ58.1 vs. Δ51.6; P = 0.0.60) respectively. About 4.1% of CDA patients and 4.9% of ACDF patients had serious adverse events related to study device. Mean angular motions at index level for BRYAN disc and ACDF were 8.69° and 0.60°, respectively. CONCLUSION: CDA can preserve and maintain motion in the long term compared with ACDF. There was a trend toward fewer adjacent segment surgeries for BRYAN disc that did not reach significance. Significant improvement in CDA NDI scores may suggest better long-term success for CDA as compared to fusion.2.

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