AxiaLIF vs. ALIF: Retrospective Results
Walter Eisner • Wed, August 8th, 2012
How does TranS1 Inc.'s AxiaLIF (Axial Lumbar Interbody Fusion) pre-sacral interbody fusion procedure compare to ALIF (Anterior Lumbar Interbody Fusion) for effectiveness and safety.
According to the first head-to-head retrospective study, AxiaLIF demonstrated improved fusion rates over ALIF, but the difference in rates were not statistically significant.
TranS1 Inc. announced the results of the study on August 2.
Two independent spine surgeons evaluated 96 total patients, with 48 patients in each arm, at two year or greater follow up with thin slice CT scans.
Adverse Event Comparison
The combined review of both surgeons demonstrated the results. Strict radiographic criteria were employed to determine bridging bone between the vertebral bodies. Perhaps most interestingly given concerns over the AxiaLIF approach, the AxiaLIF cohort experienced no serious adverse events, compared with the ALIF cohort, which reported two serious adverse events. Ten sites contributed patients to this study.
Ken Reali, president and CEO of TranS1, stated, "This study represents an important contribution to the growing base of clinical research on pre-sacral interbody fusion. TranS1 is committed to clinical studies demonstrating the safety, efficacy and cost effectiveness of AxiaLIF."
The study represented the use of AxiaLIF 1L (L5-S1) with pedicular fixation versus ALIF (L5-S1) with pedicular fixation. Follow-up time points ranged from a minimum of two years to a maximum of six years for the AxiaLIF group and two years to nine-year follow-up for the ALIF group.
In an AxiaLIF approach, the surgeon accesses the patient’s lower back through an approximately one-inch incision next to the tailbone. The center of the degenerated disc is removed, and bone growth material is inserted in its place. This material helps bone growth over time in order to fuse the spine.
With the ALIF, a traditionally open procedure, the surgeon enters through the abdomen to access the lower portion of the spine.
The study will be submitted for publication by lead author Peter G. Whang, M.D., Associate Professor of Orthopaedics and Rehabilitation at Yale University, to a peer-reviewed spine journal. Preliminary data on a subset of patients was recently presented as a poster at the International Meeting of Spine Techniques (IMAST), which was held in Istanbul, Turkey on July 19-21.