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ProDisc-L arthroplasty superior to fusion for degenerative disc disease at 2 years

Investigators in the IDE study reported pain relief, less blood loss with artificial disc surgery.
By Susan M. Rapp
1st on the web (October 4, 2006)

October 2006

SEATTLE — An artificial lumbar disc prosthesis provides better postoperative function compared to fusion as a treatment for patients with degenerative disc disease, a multicenter study found.

Rick B. Delamarter, MD, associate clinical professor in the department of surgery, University of California-Los Angeles School of Medicine, conducted the study with colleagues at 17 centers in the United States under an FDA investigational device exemption (IDE). The prospective trial compared outcomes between the ProDisc-L (Synthes Inc.) implant and circumferential fusion in 242 patients.

Researchers randomly assigned 162 patients to treatment with the device, which surgeons implanted at L3-S1, and assigned 80 patients to fusion at the same levels. Most patients were operated on at L5-S1, said Delamarter, who presented the results at the North American Spine Society 21st Annual Meeting, here.

Both groups had significant improvements in Oswestry Low Back Disability Index (ODI) scores and Visual Analog Scale (VAS) scores at all postoperative follow-ups out to 2 years compared to baseline scores (P<.0001). However, 64% of patients treated with ProDisc-L reported a 15-point improvement in ODI scores vs. 45% of fusion patients (P<.04), according to the study.

Patients treated with the ProDisc-L also experienced half as much blood loss during surgery compared to fusion patients, Delamarter noted. Patients treated with the ProDisc-L had a mean blood loss of 204 ± 231.3 cc vs. 465 ± 440 cc for fusion patients (P<.0001), according to the study.

Both groups had similarly low complication rates and postop infections. Surgeons performed reoperations in 4% of ProDisc-L-treated patients and in 5% of fusion patients, according to the study.

"ProDisc was superior to fusion, even at a fusion rate of 97%," Delamarter said.

For more information:

* Delamarter RB, Zigler J, Spivak J, et al. Lumbar total disc replacement with the ProDisc-L artificial disc versus fusion: A prospective randomized multi-center Food and Drug Administration IDE trial. #113. Presented at the North American Spine Society 21st Annual Meeting. Sept. 26-30, 2006. Seattle.