Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled clinical trial

Presented at the 2009 Joint Spine Section Meeting

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The purpose of this study was to determine long-term clinical outcomes in patients undergoing anterior cervical surgery in which a cervical disc prosthesis was used to treat single-level degenerative cervical disc disease.


In this prospective, nonblinded study, 541 patients at 32 investigational sites were randomly assigned to 1 of 2 treatment groups. The results of the investigational group, in which patients received the Prestige disc prosthesis, were compared with those of the control group, in which patients underwent an instrumented interbody fusion. Data were collected preoperatively, intraoperatively, and at 1.5, 3, 6, 12, 24, 36, and 60 months postoperatively. To date, 271 patients have completed 5 years of clinical follow-up (144 investigational and 127 control patients).


Significant improvements in Neck Disability Index (NDI) scores, Physical Component Summary scores of the 36-Item Short-Form Health Survey, and neck and arm pain scores were achieved by 1.5 months in both groups and sustained at 5 years. The mean NDI improvements from preoperative scores were 35.4, 36.3, and 38.4 at 24, 36, and 60 months, respectively, in the investigational group. The corresponding mean NDI improvements were 33.9, 31.3, and 34.1 in the control group. The intergroup differences at both 36 and 60 months were significant (p = 0.008 and 0.022, respectively). The overall rates of maintenance or improvement in neurological status in the investigational group were 91.6%, 92.8%, and 95.0%, respectively, at 24, 36, and 60 months compared with 83.6%, 83.2%, and 88.9% in the control group (p = 0.006, 0.004, and 0.051, respectively). The implant effectively maintained angular motion, averaging more than 7.3° at 36 months and 6.5° at 60 months after surgery. No implant migration was observed up to 60 months. There were statistically significant differences between the investigational and control groups with regard to the rate of revision and supplemental fixation surgical procedures performed subsequent to the index procedure. Additional surgical procedures for adjacent-segment disease were observed in both treatment groups. Rates for surgery at adjacent levels trended lower in the investigational group (8 patients [11 surgeries]) compared with those in the control group (13 patients [16 surgeries]), but the differences were not statistically significant (p = 0.376). Some of the second surgeries involved both index and adjacent levels.


The Prestige disc maintains improved clinical outcomes and segmental motion after implantation at 5-year follow-up.

Abbreviations used in this paper:IDE = investigational device exemption; LOCF = last observation carried forward; NDI = Neck Disability Index; PCS = Physical Component Summary; SF-36 = 36-Item Short-Form Health Survey.

Article Information

Address correspondence to: J. Kenneth Burkus, M.D., The Hughston Clinic, 6262 Veterans Parkway, Columbus, Georgia, 31908-9517. email: jkb66@knology.net.

© AANS, except where prohibited by US copyright law.



  • View in gallery

    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. A: Dynamic lateral radiograph showing extension measurement technique. B: Dynamic lateral radiograph showing flexion measurement technique.

  • View in gallery

    Mean NDI scores in the investigational group (solid line) and control group (broken line).

  • View in gallery

    Mean neck pain scores in the investigational group (solid line) and control group (broken line).

  • View in gallery

    Mean arm pain scores in the investigational group (solid line) and control group (broken line).

  • View in gallery

    Mean SF-36 PCS scores in the investigational group (solid line) and control group (broken line).

  • View in gallery

    Neurological success rates in the investigational group (black bars) and control group (gray bars).

  • View in gallery

    Mean angular motion at index surgical level in the investigational group (solid line) and control group (broken line).



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