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Patients with artificial cervical discs maintain clinical outcomes at 7 years follow-up

Cervical disc arthroplasty was associated with better NDI scores and less neck pain compared to ACDF at long-term follow-up, researchers said.

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SAN FRANCISCO — A recent study showed that clinical and radiographic outcomes 7 years after patients underwent 1-level cervical disc replacement were better than those in patients who underwent anterior cervical discectomy and fusion.

“It is the largest 7 year prospective randomized data of any of the arthroplasty studies. Segmental motion is maintained at 7 years, and for those patients in whom we have follow-up they did have a statistically lower rate of adjacent segment degeneration,” Praveen V. Mummaneni, MD, FAANS, said at the American Association of Neurological Surgeons Annual Meeting, here.

A disc implant versus fusion

Mummaneni and colleagues compared the 7-year clinical outcomes of 276 patients in the study’s investigational group who underwent anterior cervical discectomy and arthroplasty with the Prestige Cervical Disc (Medtronic; Memphis, Tenn.) to 265 control group patients who underwent anterior cervical discectomy and fusion (ACDF). Clinical and radiographic evaluations were performed preoperatively, intraoperatively, and at 1.5 months, 3 months, 6 months, 12 months, 24 months, 36 months, 60 months and 84 months.

At the 5 year follow-up in the investigational group, 220 patients remained, Mummaneni said. Two patients died, five patients withdrew from the study and 49 patients were lost to follow-up. By the 84 month follow-up, 15 fewer patients were available for the analysis, he said.
In the control group, 183 patients remained at the 7-year follow up, with patients not completing the study for about the same reasons.

Scores improve with disc implants

Throughout the 7 years of follow-up, Mummaneni and colleagues tracked the patients’ neck range of motion, Neck Disability Index (NDI) scores, neck pain scores and neurological status.

“If you look at the arm pain scores between the groups they were initially very high, and they get much better, and then basically stay excellent through the final follow-up time point. There is no statistical difference at 84 months between the ACDF and arthroplasty,” Mummaneni said. “If you look at neck pain early on, you did not see much of a statistical difference. At the 2 year time point, 3 year time point, there still is not much statistical difference. At 60-months and 84 month time point, though, we are seeing statistical improvement in neck pain in the arthroplasty group as compared to the ACDF, and this may be because of the revision surgery rates. The NDI score at 60 [months] and 80-months months is statistically better in the arthroplasty group as well, and that again might be due to repeat operations.”

Mummaneni and colleagues reported neurological success rates at the 84 month time point were similar in the two groups.

Postoperatively, the implant effectively maintained average angular motion of 6.67° at 60 months and 6.75° at 84 months. Patients in the ACDF group did not have any range of motion at the fused segment, according to the study abstract.

Investigators observed one implant migration at 84 months.

“Rates for surgery at the index level trended lower in the investigational group (11/276; 4%) when compared to the control group (29/265; 10.9%), 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. 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,” Mummaneni and colleagues wrote.

The authors concluded the Prestige disc implant maintains improved clinical outcomes at the 7-year follow up. – by Robert Linnehan