The Bryan cervical disc system

被引：11

作者：

Papadopoulos, S ^{[1
]}

机构：

[1] Barrow Neurol Inst, Phoenix, AZ 85013 USA

来源：

NEUROSURGERY CLINICS OF NORTH AMERICA | 2005年 / 16卷 / 04期

关键词：

D O I：

10.1016/j.nec.2005.06.003

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

In May 2002, an Investigational Device Exemption (IDE) was granted by the US Food and Drug Administration (FDA) for clinical evaluation of the Bryan Cervical Disc System. The trial was designed to demonstrate equivalence with anterior discectomy and interbody fusion with plate fixation. Trial enrollment of over 500 patients was completed in 2004, and 2-year follow-up data are currently being collected and analyzed in preparation for submission to the FDA. This article describes the Bryan prosthesis, reviews several preclinical and clinical studies, and reports on the IDE study.

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页码：629 / +

页数：9

相关论文

共 11 条

[1] Wear analysis of the Bryan Cervical Disc prosthesis [J].

Anderson, PA ;

Rouleau, JP ;

Bryan, VE ;

Carlson, CS .

SPINE, 2003, 28 (20) :S186-S194

[2]

Anderson Paul A, 2004, Spine J, V4, p303S, DOI 10.1016/j.spinee.2004.07.026

[3] Biomechanical study on the effect of cervical spine fusion on adjacent-level intradiscal pressure and segmental motion [J].

Eck, JC ;

Humphreys, SC ;

Lim, TH ;

Jeong, ST ;

Kim, JG ;

Hodges, SD ;

An, HS .

SPINE, 2002, 27 (22) :2431-2434

[4] A kinematic study of the cervical spine before and after segmental arthrodesis [J].

Fuller, DA ;

Kirkpatrick, JS ;

Emery, SE ;

Wilber, RG ;

Davy, DT .

SPINE, 1998, 23 (15) :1649-1656

[5] IN-VIVO INFLAMMATORY RESPONSE TO POLYMETHYLMETHACRYLATE PARTICULATE DEBRIS - EFFECT OF SIZE, MORPHOLOGY, AND SURFACE-AREA [J].

GELB, H ;

SCHUMACHER, HR ;

CUCKLER, J ;

BAKER, DG .

JOURNAL OF ORTHOPAEDIC RESEARCH, 1994, 12 (01) :83-92

[6] Long-term follow-up after interbody fusion of the cervical spine [J].

Goffin, J ;

Geusens, E ;

Vantomme, N ;

Quintens, E ;

Waerzeggers, Y ;

Depreitere, B ;

Van Calenbergh, F ;

van Loon, J .

JOURNAL OF SPINAL DISORDERS & TECHNIQUES, 2004, 17 (02) :79-85

[7] Preliminary clinical experience with the Bryan Cervical Disc Prosthesis [J].

Goffin, J ;

Casey, A ;

Kehr, P ;

Liebig, K ;

Lind, B ;

Logroscino, C ;

Pointillart, V ;

Van Calenbergh, F ;

van Loon, J .

NEUROSURGERY, 2002, 51 (03) :840-845

[8] Intermediate follow-up after treatment of degenerative disc disease with the Bryan Cervical Disc Prosthesis: Single-level and bi-level [J].

Goffin, J ;

Van Calenbergh, F ;

van Loon, J ;

Casey, A ;

Kehr, P ;

Liebig, K ;

Lind, B ;

Logroscino, C ;

Sgrambiglia, R ;

Pointillart, V .

SPINE, 2003, 28 (24) :2673-2678

[9] Radiculopathy and myelopathy at segments adjacent to the site of a previous anterior cervical arthrodesis [J].

Hilibrand, AS ;

Carlson, GD ;

Palumbo, MA ;

Jones, PK ;

Bohlman, HH .

JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME, 1999, 81A (04) :519-528

[10] Cervical arthroplasty in the management of spondylotic myelopathy [J].

Sekhon, LHS .

JOURNAL OF SPINAL DISORDERS & TECHNIQUES, 2003, 16 (04) :307-313