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Total disc replacement clinical outcomes superior to those of spinal fusion at 2 years

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GENEVA — Swedish spine researchers said total lumbar disc replacement should be given greater consideration as the new gold standard for surgical treatment of patients with chronic low back pain that is discogenic and unresponsive to conservative treatment.

Investigators from Stockholm Spine Center and University Hospital in Linköping, Sweden, compared the clinical outcomes of 152 patients who received either total disc replacement (TDR) or the more conventional lumbar fusion in a prospective, randomized, controlled comparison study.

All patients had failed a conservative treatment program, and low back pain was the predominant symptom, Svante Berg, MD, said at Spine Week 2008, here.

Of the 152 patients included in the study, 80 underwent TDR and 72 had instrumented fusion. The mean patient age was 40 years.

Patients who underwent TDR received the Maverick (Medtronic Spine), ProDisc (Synthes Spine) or Charité (DePuy Spine) disc implants.

The follow-up rate was 100% at 1 year and 97% at 2 years. All main clinical outcome parameters improved for both groups, the investigators reported.

"After the first year, the TDR patients showed a greater improvement in their Visual Analog Scale pain score, their Oswestry Disability Index score, the EuroQol score and global assessment score than the fusion group," Berg said. In the TDR group, 29% of patients reported total relief of their back pain compared to 10% in the fusion group.

Those differences between the groups continued at 2-year follow-up, he said.

"We did not see a statistically significant change in results between 1 and 2 years for the TDR group," he added. However, 15% of patients in the fusion group reported total relief of their back pain after 2 years.

Berg noted that while these early results offer support for the TDR approach, "we will continue to follow these patients to see if there is still a difference" over the longer term, he said.

For more information:

• Berg S, Tropp H, Holt RT, Majd ME. Comparison of total disc replacement with lumbar fusion surgery: A randomized controlled trial with 2-year follow-up. Paper C5. Presented at Spine Week 2008. May 26-31, 2008. Geneva, Switzerland.