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J. Kenneth Burkus, Vincent C. Traynelis, Regis W. Haid Jr., and Praveen V. Mummaneni

Object

The authors assess the long-term safety and efficacy of cervical disc replacement with the Prestige Cervical Disc in a prospective, randomized, multicenter trial at 7 years of follow-up.

Methods

At 31 investigational sites, 541 patients with single-level cervical disc disease with radiculopathy were randomized to 1 of 2 treatment groups: 276 investigational group patients underwent anterior cervical discectomy and arthroplasty with the Prestige disc, and 265 control group patients underwent anterior cervical discectomy and fusion. Clinical outcomes included Neck Disability Index, the 36-Item Short-Form Health Survey, and neck and arm pain scores. Radiographs were assessed for angle of motion and fusion. Clinical and radiographic outcomes were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, 24, 36, 60, and 84 months.

Results

Of the 541 patients treated, 395 patients (73%; 212 investigational and 183 control patients) completed 7 years of clinical follow-up. Significant improvements achieved by 1.5 months in both groups were sustained at 7 years. In the investigational group, mean Neck Disability Index improvements from preoperative scores were 38.2 and 37.5 at 60 and 84 months, respectively. In the control group, the corresponding means were 33.8 and 31.9. The differences between the investigational and control groups at the 60-month and 84-month periods were significant (p = 0.014 and 0.002, respectively). The overall rates of maintenance or improvement in neurological status in the investigational group were significantly higher: 92.2% and 88.2% at 60 months and 84 months, respectively, compared with 85.7% and 79.7% in the control group (p = 0.017 and 0.011, respectively). At 84 months, the percentage of working patients in the investigational group was 73.9%, and in the control group, 73.1%. Postoperatively, the implant effectively maintained average angular motion of 6.67° at 60 months and 6.75° at 84 months. Cumulative rates for surgery at the index level were lower (p < 0.001) in the investigational group (11 [4.8%] of 276) when compared with the control group (29 [13.7%] of 265) (based on life-table method), and there were statistical differences between the investigational and control groups with specific regard to the rate of subsequent revision and supplemental fixation surgical procedures. Rates for additional surgical procedures that involved adjacent levels were lower in the investigational group than in the control group (11 [4.6%] of 276 vs 24 [11.9%] of 265, respectively).

Conclusions

Cervical disc arthroplasty has the potential for preserving motion at the operated level while providing biomechanical stability and global neck mobility and may result in a reduction in adjacent-segment degeneration. The Prestige Cervical Disc maintains improved clinical outcomes and segmental motion after implantation at 7-year follow-up. Clinical trial registration no. NCT00642876 (ClinicalTrials.gov).

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J. Kenneth Burkus, Regis W. Haid Jr., Vincent C. Traynelis, and Praveen V. Mummaneni

Object

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.

Methods

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).

Results

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.

Conclusions

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

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Praveen V. Mummaneni, J. Kenneth Burkus, Regis W. Haid, Vincent C. Traynelis, and Thomas A. Zdeblick

Object

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).

Methods

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.

Conclusions

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.

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Shabbar F. Danish and Paul J. Marcotte