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Disc replacement shows statistical superiority over interbody fusion devices

The metal-on-metal total disc replacement group had better mean improvements in SF-36 PCS and ODI scores at all postoperative time points in lumbar study.

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AUSTIN, Texas — A new Level 1 study indicates statistical superiority for total disc replacement using a two-piece, metal-on-metal device compared to anterior lumbar interbody fusion performed using bone graft in a cage device in patients with single-level symptomatic degenerative disc disease.

In a prospective, randomized, multicenter trial, investigators studied nearly 600 patients who received either total disc replacement (TDR) using the Maverick prosthesis (Medtronic) or anterior lumbar interbody fusion (ALIF) using bone graft and an LT-CAGE (Medtronic, Sofamor Danek) up to 24 months postoperatively. The investigational device exemption trial included patients with single-level symptomatic degenerative disc disease (DDD) who failed 6 months of conservative care.

The investigators discovered that the TDR group showed statistically better improvements compared to the fusion group in the Oswestry Disability Index (ODI), SF-36 PCS, back pain and patient satisfaction scores at all postoperative follow-up points.

"If we look at ODI success as a 15-point improvement, this is the first study to ever have any group of patients to have greater than 80% success," said Matthew F. Gornet, MD, in a presentation at the North American Spine Society 22nd Annual Meeting, held here. "The Maverick [group] was able to do so at 6 months on. More importantly, statistically superiority was concluded for the Maverick for 15-point improvement at 24 months compared to our fusion control [group]," he said.

The TDR group also returned to work 21 days earlier, and 86% of the patients reported that they would undergo the procedure again vs. 73% of the fusion group.

The investigators used a composite measure of variables to determine the primary study endpoint, which was basically overall study success, Gornet said. "The conclusion supported not only non-inferiority but superiority for Maverick compared to our fusion control."

For more information:

• Gornet MF, Burkus JK, Mathews HH, et al. MAVERICK total disc replacement vs. anterior lumbar interbody fusion with the INFUSE bone graft/LT-CAGE device: A prospective, randomized, controlled, multicenter IDE trial. Paper #1. Presented at the North American Spine Society 22nd Annual Meeting. Oct. 23-27, 2007. Austin, Texas. He has indicated that he is not a Medtronic consultant and received no financial remuneration from them for this study.