402 - Axial Presacral L4 to S1 Interbody Fusion Using AxiaLIF and Posterior...

#402 Axial Presacral L4 to S1 Interbody Fusion Using AxiaLIF and Posterior Instrumentation. Clinical Outcomes

General Session: Advocacy of MIS

Presented by: W. Tobler


W.D. Tobler (1), (2)
T.J. Raley (3)
N. Anand (4)
R.J. Nasca (5)
M.A. Melgar (6)

(1) University of Cincinnati, Neurosurgery, Cincinnati, OH, USA
(2) Mayfield Clinic, Cincinnati, OH, USA
(3) Advanced Spine and Pain, Arlington, VA, USA
(4) Cedars Sinai Medical Center, Los Angeles, CA, USA
(5) Orthopedic and Spine Surgery, Wilmington, NC, USA
(6) Tulane University, Neurosurgery, New Orleans, LA, USA


Introduction: The primary aim of this retrospective clinical series was to evaluate the clinical and radiographic outcomes of patients treated with a L4-S1 interbody fusion using an axial presacral approach.There are several methods of performing interbody fusions for various disorders of the lumbar spine unresponsive to non- operative treatment. Each requires exposure and removal of musculoligamentous and osseous structures and potential damage to neural and vascular tissue. The presacral axial approach spares disruption of these musculoligamentous and osseous structures as well as vascular and neurologic tissue to gain access to the intervertebral disc space for fusion.

Methods: Fifty-two patients from four clinical sites were selected if they underwent a L4-L5 and L5-S1 interbody fusion via a presacral approach with the AxiaLIF two level system (TranS1,Wilmington,NC) and had preoperative and postoperative clinical and radiographic follow-up of one year or more. Outcomes were measured using the 0 to 10 point Visual Analogue Scale (VAS), the 100 point Oswestry Disability Index (ODI) and Odom's Criteria. Flexion and extension radiographs and CT scans were used to evaluate fusion.

Result: All procedures were technically successful with no bowel injury, vascular injury, deep infection, neurologic complication, implant failure or subsidence noted. Median procedural blood loss was 220 cc and median length of hospital stay was 3 days. Mean back pain severity improved from 7.7±1.6 at baseline to 3.4±2.7 at the 2-year follow-up visit (p< 0.001), representing an average 56% improvement. Back pain severity clinical success, defined as a ≥30% improvement from baseline, was realized in 75% of patients at 2 years. Mean ODI scores improved from 60±16% at baseline to 35±27% at 2 years (p< 0.001), representing an average 42% improvement. ODI clinical success, defined as a ≥30% improvement from baseline, was realized in 50% of patients at 2 years. At final follow-up, 44 (85%) patients were rated as good or excellent, 6 as fair, and 2 as poor using Odom's criteria. Interbody fusion was observed in 97 (93.3%) of 104 treated interspaces at final follow-up. One patient's bone graft extravasated into the spinal canal during the procedure and was removed by laminectomy without any permanent neurologic deficit. Three patients had removal of misplaced facet screws. One patient had a laminectomy at 6 months for removal of a BMP induced cyst. One pedicle screw was repositioned.

Conclusions: Findings from this series of patients treated with a two level presacral interbody fusion stabilized with the AxiaLIF two level device showed improvement in pain and function without any significant complications at 29 months average follow-up.