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Similar clinical results seen with lumbar disc device and interbody fusion at 5-year follow-up

The longer-term findings of the IDE study confirm those seen at 2-years postoperative follow-up.

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AUSTIN, Texas — The 5-year results of an investigational device exemption study comparing total disc replacement using the Charité disc to anterior lumbar interbody fusion with Bagby and Kuslich (BAK) cages indicate no significant differences between the groups regarding clinical outcomes.

However, significantly more patients in the Charité disc (DePuy) group were working full-time and less were on long-term disability, according to Richard D. Guyer, MD.

Guyer presented results of the multicenter study at the North American Spine Society 22nd Annual Meeting, held here.

The study followed 38 patients who received total disc replacement with the Charité disc and 14 patients who underwent anterior lumbar interbody fusion (ALIF) with BAK (Sulzer Medica) cages. Using the FDA's criteria for success, investigators found a 58% overall success rate for the Charité disc group and a 51% overall success rate for the ALIF group.

Also, both groups had significant improvements in the Oswestry Disability Index (ODI), Short Form-36 (SF-36) and visual analog scale (VAS) scores over baseline at 5 years postop, with no significant differences between the groups.

"The 5-year data was consistent with the 2-year data," Guyer said. "There's no difference between the two groups. However, there was a statistically greater rate of full-time employment and a lower rate of long-term disability."

Of the patients in the Charité disc group, 66% worked full-time compared to 47% of the ALIF group. In addition, only 8% of the Charité disc group were on long-term disability vs. 21% of the ALIF group.

"The mean range of motion was not statistically different compared to 2-year data. This level-one study [provides] the only randomized, controlled data for arthroplasty with 5-year follow-up at the present time and hopefully will set the standard for all major studies," Guyer said.

For more information:

• Richard D. Guyer, MD, has indicated that he receives royalties from DePuy.
• Guyer RD, Banco R, Geisler F. Lumbar arthroplasty vs. anterior interbody fusion at one-level: Clinical results at five-year follow-up from the IDE study of the Charité Artificial Disc. #170. Presented at the North American Spine Society 22nd Annual Meeting. Oct. 23-27, 2007. Austin, Texas.