A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemptions Study of Lumbar Total Disc Replacement With the CHARITÉ™ Artificial Disc Versus Lumbar Fusion: Part I: Evaluation of Clinical Outcomes


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Abstract

Study Design.A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial.Objectives.The purpose of this study was to compare the safety and effectiveness of lumbar total disc replacement, using the CHARITÉ™ artificial disc (DePuy Spine, Raynham, MA), with anterior lumbar interbody fusion, for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment.Summary of Background Data.Reported results of lumbar total disc replacement have been favorable, but studies have been limited to retrospective case series and/or small sample sizes.Methods.Three hundred four (304) patients were enrolled in the study at 14 centers across the United States and randomized in a 2:1 ratio to treatment with the CHARITÉ™ artificial disc or the control group, instrumented anterior lumbar interbody fusion. Data were collected pre- and perioperatively at 6 weeks and at 3, 6, 12, and 24 months following surgery. The key clinical outcome measures were a Visual Analog Scale assessing back pain, the Oswestry Disability Index questionnaire, and the SF-36 Health Survey.Results.Patients in both groups improved significantly following surgery. Patients in the CHARITÉ™ artificial disc group recovered faster than patients in the control group. Patients in the CHARITÉ™ artificial discgroup had lower levels of disability at every time interval from 6 weeks to 24 months, compared with the control group, with statistically lower pain and disability scores at all but the 24 month follow-up (P < 0.05). At the 24-month follow-up period, a significantly greater percentage of patients in the CHARITÉ™ artificial disc group expressed satisfaction with their treatment and would have the same treatment again, compared with the fusion group (P < 0.05). The hospital stay was significantly shorter in the CHARITÉ™ artificial disc group (P < 0.05). The complication rate was similar between both groups.Conclusions.This prospective, randomized, multicenter study demonstrated that quantitative clinical outcome measures following lumbar total disc replacement with the CHARITÉ™ artificial disc are at least equivalent to clinical outcomes with anterior lumbar interbody fusion. These results support earlier reports in the literature that total disc replacement with the CHARITÉ™ artificial disc is a safe and effective alternative to fusion for the surgical treatment of symptomatic disc degeneration in properly indicated patients. The CHARITÉ™ artificial disc group demonstrated statistically significant superiority in two major economic areas, a 1-day shorter hospitalization, and a lower rate of reoperations (5.4% compared with 9.1%). At 24 months, the investigational group had a significantly higher rate of satisfaction (73.7%) than the 53.1% rate of satisfaction in the control group (P = 0.0011). This prospective randomized multicenter study also demonstrated an increase in employment of 9.1% in the investigational group and 7.2% in the control group.

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