Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial

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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.

Article Information

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:

© AANS, except where prohibited by US copyright law.



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    Artist's rendering of the PRESTIGE ST Cervical Disc System implanted in the cervical spine.

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    A: Artist's rendering (lateral view) of the cervical spine with implant in place. Sagittal-plane angulation is measured using the Cobb method. A line is drawn perpendicular to the superior and inferior endplates of the adjacent vertebrae. B and C: Dynamic lateral radiographs show flexion (B) and extension (C) measurement techniques.

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    Graphic and tabular summaries of follow-up rates.

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    Graphic and tabular representations of NDI scores. The NDI was used to measure the effects of neck pain on a patient's function in performing activities of daily living. (The probability values were derived using an analysis of variance. One-sided probability values are reported here. The preoperative score is treated as a covariate in the analysis.)

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    Bar graph demonstrating NDI score success. The NDI success criterion is a function of the preoperative NDI score. A minimum 15-point postoperative improvement in NDI score was required to be deemed a successful outcome.

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    Bar graphs showing the SF-36 PCS scores (upper) and MCS scores (lower). The PCS score reflects the Physical Functioning, Role–Physical Bodily Pain, and General Health outcomes; the MCS score represents Vitality, Social Functioning, Role–Emotional, and Mental Health outcomes. (The probability values were derived using an analysis of covariance. One-sided probability values are reported here. The preoperative score is treated as a covariate in analysis.)

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    Bar graphs demonstrating the neck pain (upper) and arm pain (lower) scores. Numeric rating scales were used to assess neck/arm pain intensity and duration. (The probability values were derived using an analysis of covariance. One-sided probability values are reported here. The preoperative score is treated as a covariate in analysis.)

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    Bar graph showing mean neurological success rates, which were based on maintenance or improvement in postoperative neurological functioning compared with preoperative status. The superiority probability values were calculated using the Fisher exact test. One-sided superiority probability values are reported here.

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    Line graph demonstrating segmental sagittal angular motion at the treated level.

  • View in gallery

    Bar graph providing a summary of overall clinical success rates.



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