Cervical Disc Arthroplasty with Prestige LP Disc Versus Anterior Cervical Discectomy and Fusion: Seven-Year Outcomes

被引:57
作者
Gornet, Matthew F. [1 ]
Burkus, J. Kenneth [2 ]
Shaffrey, Mark E. [3 ]
Nian, Hui [4 ]
Harrell, Frank E., Jr. [4 ]
机构
[1] Orthoped Ctr St Louis, St Louis, MO USA
[2] Hughston Clin, Wilderness Spine Serv, Columbus, GA USA
[3] Univ Virginia, Dept Neurosurg, Charlottesville, VA 22903 USA
[4] Vanderbilt Univ, Sch Med, Dept Biostat, Nashville, TN 37235 USA
关键词
CERVICAL DISC ARTHROPLASTY; ANTERIOR CERVICAL DISCETOMY AND FUSION; ARTIFICAL CERVICAL DISC; CERVICAL RADICULoPATHY; CERVICAL MYELOPATHY; ADJACENT LEVEL DISEASE;
D O I
10.14444/3024
中图分类号
R61 [外科手术学];
学科分类号
摘要
Background Cervical disc arthroplasty (CDA) has emerged as an alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of cervical pathologies. Studies are on-going to assess the long term outcomes of CDA. This study assessed the safety and efficacy of the Prestige((R)) LP Disc at 84-months follow up. Methods Prospective data from 280 CDA patients with single-level cervical disc disease with radiculopathy or myelopathy were compared with 265 historical control ACDF patients. Clinical and radiographic follow up was completed preoperatively, intraoperatively, and at intervals up to 84 months. Results Follow-up rate was 75.9% for CDA and 70.0% for ACDF patients. Statistical improvements (p<0.001) in Neck Disability Index (NDI), neck/arm pain, and SF-36 were achieved by 1.5 months in both groups and maintained through 84 months. At 84 months, 86.1% of CDA versus 80.1% of ACDF patients achieved NDI success, (>= 15-point improvement over baseline). Mean NDI score improvements exceeded 30 points in both groups. SF-36 PCS/MCS mean improvements were 13.1 +/- 11.9/8.2 +/- 12.3 points for CDA and 10.7 +/- 11.8/8.3 +/- 13.6 points for ACDF. Neurological success was 92.8% for CDA and 79.7% for ACDF patients. The rate of Overall Success was 74.9% for CDA and 63.2% for ACDF. At 84 months, 17.5% of CDA and 16.6% of ACDF patients had a possibly implant-or implant-surgical procedure-related adverse event. Eighteen (6.4%) CDA and 29 (10.9%) ACDF patients had a second surgery at the index level. In CDA patients, mean angular motion at the target level was maintained at 24 (7.5 degrees) and 84 (6.9 degrees) months. Bridging bone was reported in 5.9%/9.5%/10.2%/13.0% of CDA patients at 24/36/60/84 months. Change in mean preoperative angulation of the adjacent segment above/below the index level was1.06 +/- 4.39/1.25 +/- 4.06 for CDA and (-0.23)+/- 5.37/1.25 +/- 5.07 for ACDF patients. At 84 months, 90.9% of CDA and 85.6% of ACDF patients were satisfied with the results of their treatment. Conclusions Prestige LP maintained significantly improved clinical outcomes and segmental motion; statistical superiority of CDA was concluded for overall
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页数:21
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共 32 条
[1]   Cervical Degenerative Disease Systematic Review of Economic Analyses [J].
Alvin, Matthew D. ;
Qureshi, Sheeraz ;
Klineberg, Eric ;
Riew, K. Daniel ;
Fischer, Dena J. ;
Norvell, Daniel C. ;
Mroz, Thomas E. .
SPINE, 2014, 39 (22S) :S53-S64
[2]   Comparison of Clinical Outcomes of 1-and 2-Level Total Disc Replacement [J].
Bae, Hyun W. ;
Kim, Kee D. ;
Nunley, Pierce Dalton ;
Jackson, Robert J. ;
Hisey, Michael S. ;
Davis, Reginald J. ;
Hoffman, Gregory A. ;
Gaede, Steven E. ;
Danielson, Guy O., III ;
Peterson, Daniel L. ;
Stokes, John M. ;
Araghi, Ali .
SPINE, 2015, 40 (11) :759-766
[3]   Recurrent laryngeal nerve injury with anterior cervical spine surgery - Risk with laterality of surgical approach [J].
Beutler, WJ ;
Sweeney, CA ;
Connolly, PJ .
SPINE, 2001, 26 (12) :1337-1342
[4]   Reoperations in Cervical Total Disc Replacement Compared With Anterior Cervical Fusion Results Compiled From Multiple Prospective Food and Drug Administration Investigational Device Exemption Trials Conducted at a Single Site [J].
Blumenthal, Scott L. ;
Ohnmeiss, Donna D. ;
Guyer, Richard D. ;
Zigler, Jack E. .
SPINE, 2013, 38 (14) :1177-1182
[5]   ROBINSON ANTERIOR CERVICAL DISKECTOMY AND ARTHRODESIS FOR CERVICAL RADICULOPATHY - LONG-TERM FOLLOW-UP OF 100 AND 22 PATIENTS [J].
BOHLMAN, HH ;
EMERY, SE ;
GOODFELLOW, DB ;
JONES, PK .
JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME, 1993, 75A (09) :1298-1307
[6]   Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial [J].
Burkus, J. Kenneth ;
Traynelis, Vincent C. ;
Haid, Regis W., Jr. ;
Mummaneni, Praveen V. .
JOURNAL OF NEUROSURGERY-SPINE, 2014, 21 (04) :516-528
[7]   Delayed Hyper-Reactivity to Metal Ions After Cervical Disc Arthroplasty A Case Report and Literature Review [J].
Cavanaugh, David A. ;
Nunley, Pierce D. ;
Kerr, Eubulus J., III ;
Werner, David J. ;
Jawahar, Ajay .
SPINE, 2009, 34 (07) :E262-E265
[8]   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].
Davis, Reginald J. ;
Nunley, Pierce Dalton ;
Kim, Kee D. ;
Hisey, Michael S. ;
Jackson, Robert J. ;
Bae, Hyun W. ;
Hoffman, Gregory A. ;
Gaede, Steven E. ;
Danielson, Guy O., III ;
Gordon, Charles ;
Stone, Marcus B. .
JOURNAL OF NEUROSURGERY-SPINE, 2015, 22 (01) :15-25
[9]  
Delamarter Rick B, 2010, SAS J, V4, P122, DOI 10.1016/j.esas.2010.09.001
[10]   Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study [J].
Gornet, Matthew F. ;
Burkus, J. Kenneth ;
Shaffrey, Mark E. ;
Argires, Perry J. ;
Nian, Hui ;
Harrell, Frank E., Jr. .
JOURNAL OF NEUROSURGERY-SPINE, 2015, 23 (05) :558-573