TranS1 has completed first head-to-head retrospective study, designed for comparing its proprietary AxiaLIF pre-sacral interbody fusion procedure to Anterior Lumbar Interbody Fusion (ALIF).
The trial has enrolled 48 patients in each arm of the study and two independent spine surgeons evaluated 96 total patients at two year or greater follow up with thin slice CT scans.
To determine bridging bone between the vertebral bodies, strict radiographic criteria were employed in the trial.
The results demonstrated improved fusion rates with AxiaLIF over ALIF but the difference in the rates were not statistically significant.
TranS1 president and chief executive officer Ken Reali said the 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," Reali added.