A Controlled Prospective Outcome Study of Implantable Electrical Stimulation With Spinal Instrumentation in a High-Risk Spinal Fusion Population

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Abstract

Study Design.

A series of 65 instrumented patients without stimulation were compared with a later series of 65 patients with instrumentation and implantable electrical stimulation. The groups were evaluated for risk factors, age, diagnostic groups, levels fused, and radiographic and clinical success.

Objectives.

To test the efficacy of electrical stimulation in instrumented high-risk lumbar fusions.

Summary of Background Data.

Spinal instrumentation and implantable electrical stimulation have been shown to improve fusion success rates.

Methods.

All patients were instrumented via pedicle screws and autologous bone graft. Diagnostic groups were evaluated, and the risk factors in each group were identified and compared. Postoperation management and follow-up regimen were similar in each group. Radiographs were evaluated via Dawson's criteria and confirmed by an independent radiologist. Clinical success was evaluated via the Modified Smiley-Webster Scale and confirmed by a second orthopedic surgeon.

Results.

Fusion success was 95.6% in the stimulated group compared with 87% in the nonstimulated group (P = 0.05). Clinical success was 91% in the stimulated group and 79% in the nonstimulated group (P = 0.02). In a workers' compensation subset, fusion success was 93% in the stimulated group and 81% in the nonstimulated group. Clinical success was 57% in the stimulated group and 46% in the nonstimulated group.

Conclusions.

The results from using both instrumentation and electrical stimulation in a high-risk pool of patients show a statistically significant difference, with higher rates of fusion and clinical success than in a similar pool that did not receive stimulation.

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