The authors report the results of a prospective randomized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion (ACDF) in patients treated for symptomatic single-level cervical degenerative disc disease (DDD).
Five hundred forty-one patients with single-level cervical DDD and radiculopathy were enrolled at 32 sites and randomly assigned to one of two treatment groups: 276 patients in the investigational group underwent anterior cervical discectomy and decompression and arthroplasty with the PRESTIGE ST Cervical Disc System (Medtronic Sofamor Danek); 265 patients in the control group underwent decompressive ACDF. Eighty percent of the arthroplasty-treated patients (223 of 276) and 75% of the control patients (198 of 265) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery.
Analysis of all currently available postoperative 12- and 24-month data indicated a two-point greater improvement in the neck disability index score in the investigational group than the control group. The arthroplasty group also had a statistically significant higher rate of neurological success (p = 0.005) as well as a lower rate of secondary revision surgeries (p = 0.0277) and supplemental fixation (p = 0.0031). The mean improvement in the 36-Item Short Form Health Survey Physical Component Summary scores was greater in the investigational group at 12 and 24 months, as was relief of neck pain. The patients in the investigational group returned to work 16 days sooner than those in the control group, and the rate of adjacent-segment reoperation was significantly lower in the investigational group as well (p = 0.0492, log-rank test). The cervical disc implant maintained segmental sagittal angular motion averaging more than 7°. In the investigational group, there were no cases of implant failure or migration.
The PRESTIGE ST Cervical Disc System maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success, improved clinical outcomes, and a reduced rate of secondary surgeries compared with ACDF.
Abbreviations used in this paper:ACDF = anterior cervical discectomy and fusion; DDD = degenerative disc disease; DSH = disc space height; FDA = Food and Drug Administration; MCS = Mental Component Summary; NDI = neck disability index; PCS = Physical Component Summary; SF-36 = 36-Item Short Form Health Survey; VB = vertebral body.
Address reprint requests to: Praveen V. Mummaneni, M.D., Department of Neurological Surgery, University of California, San Francisco, 505 Parnassus Avenue, M-779, Box 0112, San Francisco, California 94143. email:
BohlmanHHEmerySEGoodfellowDBJonesPK: Robinson anterior cervical discectomy and arthrodesis for cervical radiculopathy. Long-term follow-up of one hundred and twenty-two patients. J Bone Joint Surg Am75:1298–13071993
DmitrievAECunninghamBWHuNSellGVignaFMcAfeePC: Adjacent level intradiscal pressure and segmental kinematics following a cervical total disc arthroplasty: an in vitro human cadaveric model. Spine30:1165–11722005
GoffinJVan CalenberghFvan LoonJCaseyAKehrPLiebigK: Intermediate follow-up after treatment of degenerative disc disease by the Bryan Cervical Disc Prosthesis: single-level and bi-level. Spine28:2673–26782003
GoffinJvan LoonJVan CalenberghFPletsC: Long-term results after anterior cervical fusion and osteosynthetic stabilization for fractures and/or dislocations of the cervical spine. J Spinal Disord8:499–5081995
KulkarniVRajshekharVRaghuramL: Accelerated spondylotic changes adjacent to the fused segment following central cervical corpectomy: magnetic resonance imaging study evidence. J Neurosurg100:1 Suppl2–62004
McHorneyCAWareJEJrLuJFSherbourneCD: The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliuability across diverse patient groups. Med Care32:40–661994
WigfieldCCGillSNelsonRLangdonIMetcalfNRobertsonJ: Influence of an artificial cervical joint compared with fusion on adjacent-level motion in the treatment of degenerative cervical disc disease. J Neurosurg96:1 Suppl17–212002
WigfieldCCSkrzypiecDJackowskiAAdamsMA: Internal stress distribution in cervical intervertebral discs: the influence of an artificial cervical joint and simulated anterior interbody fusion. J Spinal Disord Tech16:441–4492003