[Justin]

The Spine Journal
Volume 8, Issue 5, Supplement 1, September-October 2008, Page 75S
Proceedings of the 23rd Annual Meeting of the North American Spine Society, NASS 24th Annual Meeting

Single Level ProDisc®-C Total Disc Replacement Up to Four Years Follow-up

Rudolf Bertagnoli MD, PhDa
aPro Spine ECSA, Straubing, Germany

BACKGROUND CONTEXT: Cervical total disc replacement (TDR) is an alternative to Anterior Cervical Discectomy and Fusion (ACDF) for the treatment of symptomatic cervical disc disease (SCDD). Cervical TDR has potential benefits of reducing adjacent level disc degeneration and maintaining range of motion (ROM) between vertebral bodies. Long-term study results are needed to quantify these benefits.

PURPOSE: The purpose of this study was to compare the 48 month follow-up data of the ProDisc®-C TDR to ACDF for the treatment of one level SCDD between C3-C7.

STUDY DESIGN/ SETTING: A prospective, consecutive case series.

PATIENT SAMPLE: 73 patients were treated with the ProDisc®-C TDR.

OUTCOME MEASURES: Patients reported outcomes using Neck Disability Index (NDI), Visual Analog Scale (VAS) Pain Intensity and Frequency (Neck and Arm), and SF-36 standardized questionnaires.

METHODS: Patients were assessed pre-operatively and post-operatively at 6 weeks, 3, 6, 12, 24, 36, and 48 months.

RESULTS: The median age of study patients was 46.4 years (range: 30–66 years) with an even gender distribution. The number of patients treated at each vertebral level was: C4-C5 (9); C5-C6 (35); C6-C7 (29). The mean operative time equaled 81.1 minutes; the mean blood loss was equal to 75.8 cc. The average pre-operative NDI score (51.2±18.4) was statistically significantly lower by 6 weeks post-operatively, and remained statistically lower out to 48 months (31.1±21.9). Average VAS neck pain and frequency scores improved from pre-operative levels (intensity: 7.33; frequency 8.36) to 48 months (intensity: 4.10; frequency 4.10). VAS arm pain and frequency scores improved from pre-operative levels (intensity: 6.7; frequency: 7.03) to 48 months (intensity: 2.0; frequency 2.2). VAS pain scores for neck and arm pain intensity and frequency were statistically significantly improved (p<0.05) at all post-operative time points. The SF-36 scores indicated improvement in physical and mental components at all follow-up time points. All but four patients were satisfied at all follow-up time points; of these patients, two had previous adjacent-level fusions, one was satisfied by 48 months, one was lost to follow-up after 12 months. At 48 months, ROM was maintained in >90% of patients. No device-related complications were noted and no re-operations were necessary.

CONCLUSIONS: Cervical TDR using the ProDisc®-C, as an alternative to ACDF, for SCDD, demonstrates statistically significant clinical improvement and provides long-term patient satisfaction.

FDA DEVICE/DRUG STATUS: Pro Disc C: Approved for this indication.

Copyright © 2008 Elsevier Inc. All rights reserved.