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Prospective Randomized Controlled Trial of The Stabilis Stand Alone Cage (SAC) Versus Bagby and Kuslich (BAK) Implants for Anterior Lumbar Interbody Fusion

William Lavelle,1 Robert F. McLain,2 Candace Rufo-Smith,2 David P. Gurd2

1SUNY Upstate Medical University, New York; 2The Cleveland Clinic, Ohio

Abstract

Background 

Degenerative disc disease is common and debilitating for many patients. If conservative extensive care fails, anterior lumbar interbody fusion has proven to be an alternative form of surgical management. The Stabilis Stand Alone Cage(SAC) was introduced as a method to obtain stability and fusion. The purpose of this study was to determine whether the Stabilis Stand Alone Cage (SAC) is comparable in safety and efficacy to the Bagby and Kuslich (BAK) device.

Methods 

As part of a prospective, randomized, controlled FDA trial, 73 patients underwent anterior interbody fusion using either the SAC(56%) or the BAK device (44%).

Results 

Background characteristics were similar between the two groups. There was no significant difference between the SAC and BAK groups in mean operative time or mean blood loss during surgery. Adverse event rates did not differ between the groups. Assessment of plain radiographs could not confirm solid fusion in 63% of control and 71% of study patients. Functional scores from Owestry and SF-36 improved in both groups by the two-year follow-up. There were no significant differences between the SAC and BAK patients with respect to outcome.

Conclusions 

Both the Stabilis Stand Alone Cage and the BAK Cage provided satisfactory improvement in function and pain relief, despite less than expected radiographic fusion rates. The apparent incongruency between fusion rates and functional outcomes suggests that either radiographs underestimate the true incidence of fusion, or that patients are obtaining good pain relief and improved function despite a lower rate of fusion than previously reported. This was a Level III study.

keywords: 
anterior interbody fusion, Bagby and Kuslich Device (BAK), functional improvement, MOS 36 Item Short Form Health Survey (SF-36), Owestry scores, perioperative outcome, radiographic outcome, re-operation, Stabilis Stand Alone Cage (SAC), VAS scores
Volume 8 Article 8
doi: 
10.14444/1008