Lumbar spine arthroplasty: early results using the ProDisc II: a prospective randomized trial of arthroplasty versus fusion.

ABSTRACT

This study represents the first 39 patients with at least 6-month follow-up enrolled in a prospective randomized Food and Drug Administration study evaluating the safety and efficacy of the ProDisc II versus the control, a 360 degrees lumbar spinal fusion. Data were collected preoperatively and at 6 weeks, 3 months, and 6 months postoperatively. Visual Analog Scale (VAS), Oswestry Low Back Pain Disability Questionnaire (ODQ), and patient satisfaction rates were evaluated at these intervals, as well as range of motion, return to work, and recreational and ambulatory status. There were 28 ProDisc patients and 11 who underwent fusion. Six patients had two-level surgery. Estimated blood loss (ProDisc = 69 mL versus fusion = 175 mL) and operative time (ProDisc = 75 minutes versus fusion = 219 minutes) were significantly different (P < 0.01). Hospital stays were shorter (ProDisc = 2.1 days versus fusion = 3.5 days [P < 0.01]) for ProDisc patients. There was a significantly greater reduction in the ODQ scores at 3 months in the ProDisc group compared with the fusion group (P < 0.05). No difference was noted in VAS. A trend was identified at 6 months in patient satisfaction rates favoring ProDisc versus fusion (P = 0.08), and motion was significantly improved in ProDisc patients compared with the fusion group (P = 0.02). Ambulatory status as well as recreational activity improved faster in the ProDisc group. The data suggest that total disc arthroplasty may be an attractive option as opposed to lumbar fusion for the surgical treatment of disabling mechanical low back pain secondary to lumbar disc disease.