Mobi-C Cervical Disc Bibliography as of September 2015

Transcription

1 Mobi-C Cervical Disc Bibliography as of September 2015 PUBLISHED PAPERS Bae H, Kim KD, Nunley PD, Jackson RJ, Hisey MS, Davis RJ, Hoffman GA, Gaede SE, Danielson GO, Peterson DL, Stokes JM, Araghi A: Comparison of Clinical Outcomes of One and Two-level Total Disc Replacement with a Mobi-C Cervical Artificial Disc: 4-year Results from a Prospective, Randomized, Controlled, Multicenter IDE Clinical Trial. Spine. 40(11): , Radcliff K, Zigler Je, Zigler Ja: Costs of Cervical Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Treatment of Single-Level Cervical Disc Disease. Spine 40 (8): , Hisey MS, Bae HW, Davis R, Gaede S, Hoffman G, Kim K, Nunley PD, Peterson D, Rashbaum RF, Stokes J, Ohnmeiss DD: Prospective, Randomized Comparison of Cervical Total Disc Replacement vs. Anterior Cervical Fusion: Results at 48 Months Follow-up. J Spinal Disord Tech. 28 (4): , Davis RJ, Nunley PD, Kim KD, Hisey MS, Jackson RJ, Bae HW, Hoffman GA, Gaede SE, Danielson GO, Gordon C, Stone MB: Two-level Total Disc Replacement with Mobi-C Cervical Artificial Disc versus Anterior Discectomy and Fusion: A Prospective, Randomized, Controlled Multicenter Clinical Trial with 4 Year Follow-up Results. J Neurosurg Spine. 22(1): 15-25, Ament JD, Yang Z, Nunley P, Stone MB, Kim KD: Cost-effectiveness of cervical total disc replacement versus fusion for the treatment of two-level symptomatic degenerative disc disease. JAMA Surgery. 149 (12): , Hisey MS, Bae HW, Davis RJ, Gaede SE, Hoffman GA, Kim KD, Nunley PD, Peterson DL, Rashbaum RF, Stokes JK: Multi-center, Prospective, Randomized, Controlled Investigational Device Exemption Clinical Trial Comparing Mobi-C Cervical Artificial Disc to Anterior Discectomy and Fusion in the Treatment of Symptomatic Degenerative Disc Disease in the Cervical Spine. IJS Surgery [online journal]. 8, doi: /1007. Coric D: ISASS Policy Statement- Cervical Artificial Disc. IJS Surgery [online journal] 8, doi: /1006. Davis RJ, Nunley PD, Kim KD, Hisey MS, Bae HW, Hoffman GA, Gaede SE: Two-Level Total Disc Replacement with Mobi-C over 3-Years. Coluna/Columna. 13(2):97-103, Davis RJ, Kim KD, Hisey MS, Hoffman GA, Bae HW, Gaede SE, Rashbaum RF, Nunley PD, Peterson DL, Stokes JK: Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial. J Neurosurg Spine. 19(5): , 2013.

2 Huppert J, Beaurain J, Steib J, Bernard P, Dufour T, Hovorka I, Stecken J, Dam-Hieu P, Fuentes JM, Vital JM, Vila T, Aubourg L: Comparison between single- and multi-level patients: clinical and radiological outcomes 2 years after cervical disc replacement. Eur Spine J 20: , Beaurain J, Bernard P, Dufour T, Fuentes JM, Hovorka I, Huppert J, Steib JB, Vital JM, Aubourg L, Vila T: Intermediate clinical and radiological results of cervical TDR (Mobi-C) with up to 2 years of follow-up. Eur Spine J 18(6): , ACCEPTED Jackson RJ, Davis RJ, Hoffman GA, Bae HW, Hisey MS, Kim KD, Gaede SE, Nunley PD: Subsequent Surgery Rates after Cervical Total Disc Replacement Using a Mobi-C Cervical Disc Prosthesis versus Anterior Cervical Discectomy and Fusion: A Prospective Randomized Clinical Trial with Five-Year Follow-up. [Accepted manuscript, JNS]. IN PROCESS PAPERS Radcliff K, Albert T, Coric D: Five year clinical results of cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of two-level symptomatic degenerative disc disease: an independent critical review of the prospective, randomized, controlled multicenter investigational device exemption clinical trial. [unpublished manuscript]. SUBMITTED Ament JD, Yang Z, Nunley PD, Stone MB, Lee D, Kim KD: Cost Utility Analysis of The Cervical Artificial Disc versus Fusion for The Treatment of 2-Level Symptomatic Degenerative Disc Disease: 5-Year Follow-Up. [unpublished manuscript]. ABSTRACTS AND PRESENTATIONS CSRS 2014 Davis R, Hoffman G, Bae HW, Hisey M, Kim KD, Gaede SE, Nunley P: Maintenance of Overall Success in Patients Treated with Cervical Disc Arthroplasty and ACDF at One or Two Levels: Five-Year Results from an Investigational Device Exemption Trial [abstract]. Proceedings of the 42nd Annual Meeting of the Cervical Spine Research Society. December 4-6, Orlando, FL. Hisey MS, Bae HW, Davis R, Ohnmeiss DD: One-Level Treatment with Total Disc Replacement and ACDF: 5-year Results from a Prospective Randomized Clinical Trial [abstract]. Proceedings of the 42nd Annual Meeting of the Cervical Spine Research Society. December 4-6, Orlando, FL. Zigler JE, Rogers RW, Hisey MS, Davis RJ, Bae HW, Ohnmeiss DD: Differences in Outcomes following ACDF in Patients with One and Two Level Symptomatic Cervical Disc Disease: Follow-up at Four Years in a

3 Prospectively Collected Series of 186 Patients [abstract]. Proceedings of the 42nd Annual Meeting of the Cervical Spine Research Society. December 4-6, Orlando, FL. CSRS 2013 Davis RJ, Bae H, Hisey MS, Kim K, Nunley PD, Gaede S: Cervical Disc Arthroplasty and ACDF at Two Levels: Four-Year Results from an Investigational Device Exemption Trial [abstract]. Proceedings of the 41st Annual Meeting of the Cervical Spine Research Society. December 5-7, Los Angeles, CA. Davis RJ, Bae H, Hisey MS, Kim K, Nunley PD, Gaede S: Cervical Total Disc Replacement Results in Lower Incidence of Radiographic Degeneration than ACDF at Two Levels [abstract]. Proceedings of the 41st Annual Meeting of the Cervical Spine Research Society. December 5-7, Los Angeles, CA. NASS 2014 Bae HW, Davis RJ, Hisey MS, Nunley PD, Jackson RJ: Cervical Total Disc Replacement and Anterior Cervical Discectomy and Fusion: A Comparison of One and Two-Level Treatment [abstract]. Proceedings of the 29th Annual North American Spine Society Meeting. November 12-15, San Francisco, CA. Bae HW, Simela AT, Kanim L: What Specific Questions are Responsible in Driving NDI Superiority of Two- Level Anterior Disc Replacement over Two-Level Fusion: Post Hoc Item Analysis of Self-Reported Outcomes of Two-Level Cervical Disc Arthroplasty (CDA, Mobi-C ) Versus Two-Level ACDF Treated Patients from the IDE US-RCT [abstract]. Proceedings of the 29th Annual North American Spine Society Meeting. November 12-15, San Francisco, CA. Davis RJ, Bae HW, Hisey MS, Nunley PD, Jackson RJ: Two-Level Treatment with Total Disc Replacement versus ACDF: Results from a Prospective Randomized Clinical Trial with 5-years follow-up [abstract]. Proceedings of the 29th Annual North American Spine Society Meeting. November 12-15, San Francisco, CA. Hisey MS, Bae HW, Davis RJ, Kim KD, Nunley PD, Ohnmeiss DD: One-Level Treatment with Total Disc Replacement and ACDF: 5-year Results from a Prospective Randomized Clinical Trial [abstract]. Proceedings of the 29th Annual North American Spine Society Meeting. November 12-15, San Francisco, CA. Hisey MS, Davis RJ, Hoffman GA, Bae HW, Kim KD, Gaede SE, Nunley PD, Ohnmeiss DD: Sagittal Alignment of One-Level TDR and ACDF Patients: An Analysis of Patient Outcomes from a Randomized, Prospective, Clinical Trial [abstract]. Proceedings of the 29th Annual North American Spine Society Meeting. November 12-15, San Francisco, CA. Jackson RJ, Bae HW, Davis RJ, Hisey MS, Kim KD, Nunley PD: Subsequent Surgery Rates after Treatment with TDR or ACDF at One or Two Levels: Results from an IDE Clinical Trial with 5-Years Follow-Up [abstract]. Proceedings of the 29th Annual North American Spine Society Meeting. November 12-15, San Francisco, CA.

4 Nunley PD, Cavanaugh D, Kerr EJ, Utter A, Stone MB: Radiographic Adjacent Segment Pathology after Treatment with TDR or ACDF at One or Two Levels [abstract]. Proceedings of the 29th Annual North American Spine Society Meeting. November 12-15, San Francisco, CA. NASS 2013 Bae HW, Davis, RJ, Hoffman GA, Rashbaum RF, Nunley PD: Comparison of Outcomes Up to 48 Months After One- or Two- Level Total Disc Replacement: Results from an Investigational Device Exemption Trial [abstract]. Proceedings of the 28 th Annual North American Spine Society Meeting. October 9-12, New Orleans, LA. ISASS 2015 Hipp JA, Chan EF, Akella NS: Comparing Adjacent Level Changes Adjacent in ACDF versus Cervical Disc Arthroplasty [abstract]. Proceedings of the 15th Annual International Society for the Advancement of Spine Surgery. April 15-17, San Diego, CA. Nunley PD, Cavanaugh DA, Utter A, Kerr EJ, Stone M: Endplate Coverage and Heterotopic Ossification in Two-Level CDA Patients from an FDA IDE Randomized, Prospective, Clinical Trial [abstract]. Proceedings of the 15th Annual International Society for the Advancement of Spine Surgery. April 15-17, San Diego, CA. Radcliff K, Coric D, Albert T: Five-year Results of Cervical Total Disc Replacement Compared with Anterior Discectomy and Fusion for Treatment of 2-level Symptomatic Degenerative Disc Disease: A Prospective, Randomized, Controlled, Multicenter FDA IDE Clinical Trial [abstract]. Proceedings of the 15th Annual International Society for the Advancement of Spine Surgery. April 15-17, San Diego, CA. Nunley PD, Cavanaugh DA, Kerr EJ, Utter A, Stone M: Heterotopic Ossification and Endplate Sizing in One-level CDA Patients: Patient Outcomes from a Randomized, Prospective, Clinical Trial [abstract]. Proceedings of the 15th Annual International Society for the Advancement of Spine Surgery. April 15-17, San Diego, CA. Hisey MS, Jackson RJ, Bae HW, Davis RJ, Kim KD, Nunley PD, Ohnmeiss DO: One-Level Treatment with Total Disc Replacement and ACDF: Results from an FDA IDE Clinical Trial through 60 months [abstract]. Proceedings of the 15th Annual International Society for the Advancement of Spine Surgery. April 15-17, San Diego, CA. Davis RJ, Hisey MS, Bae HW, Kim KD, Nunley PD: Overall Success Maintenance in Cervical Disc Arthroplasty and ACDF Patients at One and Two Levels: Results from an FDA IDE Clinical Trial at Two and Five Years [abstract]. Proceedings of the 15th Annual International Society for the Advancement of Spine Surgery. April 15-17, San Diego, CA.

5 ISASS 2014 Hisey M, Davis R, Hoffman G, Bae HW, Kim KD, Gaede SE, Nunley P: Cervical Total Disc Replacement versus ACDF: Results from a FDA IDE Clinical Trial through 48 Months [abstract]. Proceedings of the 14th Annual International Society for the Advancement of Spine Surgery. April 30-May 1, Miami Beach, FL. Davis R, Hoffman G, Bae HW, Hisey M, Kim KD, Gaede SE, Nunley P: Two-Level Cervical Total Disc Replacement versus ACDF: Results of a Prospective, Randomized, Clinical Trial with 48 Months Follow-up Bae HW, Davis R, Hoffman G, Hisey M, Kim KD, Gaede SE, Nunley P: One-Level versus Two-Level Cervical Disc Arthroplasty: Comparative Results from a FDA IDE Clinical Trial with Four-Year Follow-up [abstract]. Proceedings of the 14th Annual International Society for the Advancement of Spine Surgery. April 30- May 1, Miami Beach, FL. Hisey M, Davis R, Hoffman G, Bae HW, Kim KD, Gaede SE, Nunley P: Sagittal Alignment of One-Level TDR and ACDF Patients: An Analysis of Patient Outcomes from a Randomized, Prospective, Clinical Trial Davis R, Hoffman G, Bae HW, Hisey M, Kim KD, Gaede SE, Nunley P: Sagittal Alignment of Two-Level TDR Patients: An Analysis of Patient Outcomes from an FDA IDE Randomized, Prospective, Clinical Trial l Simela A, Kanim L, Kim J, Bae HW: What Specific Questions are Responsible in Driving NDI Superiority of Two-level Anterior Disc Replacement Over Two-level Fusion. Post Hoc Item Analysis of Self-reported Outcomes of Two-level Cervical Disc Arthroplasty (CDA, Mobi-C ) vs. Two-level ACDF Treated Patients from the IDE US-RCT [abstract]. Proceedings of the 14th Annual International Society for the Advancement of Spine Surgery.