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Equivalence of cervical disc replacement device to discectomy shown in IDE study

Data presented on same day FDA letter of approvability for Pro-Disc-C released.

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AUSTIN, Texas — Two-year results of an investigational device exemption study on total disc replacement using the ProDisc-C cervical indicate noninferiority to anterior cervical discectomy and fusion for neck and arm pain relief.

In a multicenter trial, investigators studied 209 patients with single-level cervical disc disease who were randomized to receive either anterior cervical discectomy and fusion (ACDF) or total disc replacement with ProDisc-C (Synthes). The investigators found similar preoperative demographics between the groups, but discovered significantly greater OR time and blood loss in the ProDisc-C group.

Postoperatively, in both groups they found significantly lower VAS scores for arm pain intensity and frequency and VAS scores for neck pain intensity and frequency than preoperative scores throughout the study, but found no significant differences between the groups for these scores. The investigators also found similar improvements in neck disability index scores for the groups and discovered comparable neurological success and patient satisfaction. The study also revealed that the ProDisc-C group had an average range of motion of 9.3° at the operative level compared to 8.4° preoperatively.

“ACDF has always been a tough operation to beat,” Daniel Murrey, MD, said during his presentation at the North American Spine Society 22nd Annual Meeting. “The study was designed not to prove superiority, but equivalence of ProDisc-C to ADCF in terms of neurological improvement, in terms of reduction of neck and arm pain and also to maintain motion. The study was successful in proving these points.”

“Somewhat surprising to us was the way in which ProDisc-C outperformed ACDF,” he said. “We found fewer complications, fewer reoperations and a reduction of the long-term medication usage.” They discovered that two of the ProDisc-C patients required reoperation compared to nine in the fusion group. An analysis of medication usage also revealed that 94% of ProDisc-C patients were off strong narcotics at 2 years postoperatively compared to 77% of the fusion group.

On the same day as Murrey's presentation, Synthes announced it had received an approvable letter from the FDA for the device. The Pre-Market Approval (PMA) request was sent to the agency in January of this year, the company stated in a press release.

“The letter means that the FDA has concluded its review of the ProDisc-C PMA, and has determined that the device is safe and effective for use in replacing a diseased and/or degenerated intervertebral disc of the cervical spine in patients with symptomatic cervical disc disease,” the company wrote.

For more information:

• Murrey D, Janssen ME, Delamarter RB, et al. Twenty-four month results from the prospective, randomized multicenter IDE trial of ProDisc-C versus ACDF. Paper #62. Presented at the North American Spine Society 22nd Annual Meeting. Oct. 23-27, 2007. Austin, Texas.