Elsevier

The Spine Journal

Volume 10, Issue 9, Supplement, September 2010, Pages S139-S140
The Spine Journal

2-Year Results from Four IDE Study Sites: CerviCore® Intervertebral Disc vs. Fusion

https://doi.org/10.1016/j.spinee.2010.07.359Get rights and content

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Background context

The CerviCore® Intervertebral Disc is intended to replace a single cervical intervertebral disc between C3 and C7 in skeletally mature patients, increase and maintain disc height, reduce upper extremity radicular symptoms, improve function, and permit movement of the treated spine segment.

Purpose

This study compares the CerviCore® Intervertebral Disc to the gold standard of ACDF, for single-level treatment of cervical radicular symptoms.

Study design/setting

Data was collected from four of the CerviCore® IDE study sites, which was a multi-center, prospective, randomized, controlled clinical trial conducted at 25 centers in the United States.

Patient sample

At our four sites, data is available for: 49 CerviCore® patients and 49 ACDF patients at baseline and 31 CerviCore® and 26 ACDF patients at 2 years.

Outcome measures

Functionality was assessed with NDI and upper extremity pain was measured using worse arm (at pre-op) VAS.

Methods

Subjects who qualified were evaluated pre-operatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months post-operatively. Complications and adverse events were evaluated over the course of the clinical trial.

Results

Within each treatment group, the mean NDI and Worse Arm VAS results were significantly different from pre-op at all visits up to 2 years (p<.0001). The mean NDI scores (CerviCore® vs. fusion) were: 54 vs. 53 at pre-op. At 2 years, mean scores were 13 vs. 17. Differences between and within groups were not significant. The mean Worse Arm VAS scores were: 77 vs. 69 at pre-op and 16 vs. 17 at the 2 year follow-up. The difference between groups was significant at 6 weeks (p=.0483), where CerviCore®

Conclusions

Both treatments resulted in clinical improvement with CerviCore patients showing more improvement initially. Moreover, CerviCore had less surgical interventions then control. These preliminary results suggest that the CerviCore® Intervertebral Disc may be an alternative treatment for radiculopathy. Full study data is needed to confirm the findings of this small sample size.

FDA device/drug status

CerviCore Intervertebral Disc: Investigational/Not approved.

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