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Clinical and radiographic outcomes with L4–S1 axial lumbar interbody fusion (AxiaLIF) and posterior instrumentation: a multicenter study

INTRODUCTION: Previous studies have confirmed the benefits and limitations of the presacral retroperitoneal approach for L5–S1 interbody fusion. The purpose of this study was to determine the safety and effectiveness of the minimally invasive axial lumbar interbody approach (AxiaLIF) for L4–S1 fusio...

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Autores principales: Tobler, William D, Melgar, Miguel A, Raley, Thomas J, Anand, Neel, Miller, Larry E, Nasca, Richard J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3787926/
https://www.ncbi.nlm.nih.gov/pubmed/24092998
http://dx.doi.org/10.2147/MDER.S48442
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author Tobler, William D
Melgar, Miguel A
Raley, Thomas J
Anand, Neel
Miller, Larry E
Nasca, Richard J
author_facet Tobler, William D
Melgar, Miguel A
Raley, Thomas J
Anand, Neel
Miller, Larry E
Nasca, Richard J
author_sort Tobler, William D
collection PubMed
description INTRODUCTION: Previous studies have confirmed the benefits and limitations of the presacral retroperitoneal approach for L5–S1 interbody fusion. The purpose of this study was to determine the safety and effectiveness of the minimally invasive axial lumbar interbody approach (AxiaLIF) for L4–S1 fusion. METHODS: In this retrospective series, 52 patients from four clinical sites underwent L4–S1 interbody fusion with the AxiaLIF two-level system with minimum 2-year clinical and radiographic follow-up (range: 24–51 months). Outcomes included back pain severity (on a 10-point scale), the Oswestry Disability Index (ODI), and Odom’s criteria. Flexion and extension radiographs, as well as computed tomography scans, were evaluated to determine fusion status. Longitudinal outcomes were assessed with repeated measures analysis of variance. RESULTS: Mean subject age was 52 ± 11 years and the male:female ratio was 1:1. Patients sustained no intraoperative bowel or vascular injury, deep infection, or neurologic complication. Median procedural blood loss was 220 cc and median length of hospital stay was 3 days. At 2-year follow-up, mean back pain had improved 56%, from 7.7 ± 1.6 at baseline to 3.4 ± 2.7 (P < 0.001). Back pain clinical success (ie, ≥30% improvement from baseline) was achieved in 39 (75%) patients at 2 years. Mean ODI scores improved 42%, from 60% ± 16% at baseline to 35% ± 27% at 2 years (P < 0.001). ODI clinical success (ie, ≥30% improvement from baseline) was achieved in 26 (50%) patients. At final follow-up, 45 (87%) patients were rated as good or excellent, five as fair, and two as poor by Odom’s criteria. Interbody fusion observed on imaging was achieved in 97 (93%) of 104 treated interspaces. During follow-up, five patients underwent reoperation on the lumbar spine, including facet screw removal (two), laminectomy (two), and transforaminal lumbar interbody fusion (one). CONCLUSION: The AxiaLIF two-level device is a safe, effective treatment adjunct for patients with L4–S1 disc pathology resistant to conservative treatments.
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spelling pubmed-37879262013-10-03 Clinical and radiographic outcomes with L4–S1 axial lumbar interbody fusion (AxiaLIF) and posterior instrumentation: a multicenter study Tobler, William D Melgar, Miguel A Raley, Thomas J Anand, Neel Miller, Larry E Nasca, Richard J Med Devices (Auckl) Original Research INTRODUCTION: Previous studies have confirmed the benefits and limitations of the presacral retroperitoneal approach for L5–S1 interbody fusion. The purpose of this study was to determine the safety and effectiveness of the minimally invasive axial lumbar interbody approach (AxiaLIF) for L4–S1 fusion. METHODS: In this retrospective series, 52 patients from four clinical sites underwent L4–S1 interbody fusion with the AxiaLIF two-level system with minimum 2-year clinical and radiographic follow-up (range: 24–51 months). Outcomes included back pain severity (on a 10-point scale), the Oswestry Disability Index (ODI), and Odom’s criteria. Flexion and extension radiographs, as well as computed tomography scans, were evaluated to determine fusion status. Longitudinal outcomes were assessed with repeated measures analysis of variance. RESULTS: Mean subject age was 52 ± 11 years and the male:female ratio was 1:1. Patients sustained no intraoperative bowel or vascular injury, deep infection, or neurologic complication. Median procedural blood loss was 220 cc and median length of hospital stay was 3 days. At 2-year follow-up, mean back pain had improved 56%, from 7.7 ± 1.6 at baseline to 3.4 ± 2.7 (P < 0.001). Back pain clinical success (ie, ≥30% improvement from baseline) was achieved in 39 (75%) patients at 2 years. Mean ODI scores improved 42%, from 60% ± 16% at baseline to 35% ± 27% at 2 years (P < 0.001). ODI clinical success (ie, ≥30% improvement from baseline) was achieved in 26 (50%) patients. At final follow-up, 45 (87%) patients were rated as good or excellent, five as fair, and two as poor by Odom’s criteria. Interbody fusion observed on imaging was achieved in 97 (93%) of 104 treated interspaces. During follow-up, five patients underwent reoperation on the lumbar spine, including facet screw removal (two), laminectomy (two), and transforaminal lumbar interbody fusion (one). CONCLUSION: The AxiaLIF two-level device is a safe, effective treatment adjunct for patients with L4–S1 disc pathology resistant to conservative treatments. Dove Medical Press 2013-09-18 /pmc/articles/PMC3787926/ /pubmed/24092998 http://dx.doi.org/10.2147/MDER.S48442 Text en © 2013 Tobler et al. This work is published by Dove Medical Press Ltd, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Ltd, provided the work is properly attributed.
spellingShingle Original Research
Tobler, William D
Melgar, Miguel A
Raley, Thomas J
Anand, Neel
Miller, Larry E
Nasca, Richard J
Clinical and radiographic outcomes with L4–S1 axial lumbar interbody fusion (AxiaLIF) and posterior instrumentation: a multicenter study
title Clinical and radiographic outcomes with L4–S1 axial lumbar interbody fusion (AxiaLIF) and posterior instrumentation: a multicenter study
title_full Clinical and radiographic outcomes with L4–S1 axial lumbar interbody fusion (AxiaLIF) and posterior instrumentation: a multicenter study
title_fullStr Clinical and radiographic outcomes with L4–S1 axial lumbar interbody fusion (AxiaLIF) and posterior instrumentation: a multicenter study
title_full_unstemmed Clinical and radiographic outcomes with L4–S1 axial lumbar interbody fusion (AxiaLIF) and posterior instrumentation: a multicenter study
title_short Clinical and radiographic outcomes with L4–S1 axial lumbar interbody fusion (AxiaLIF) and posterior instrumentation: a multicenter study
title_sort clinical and radiographic outcomes with l4–s1 axial lumbar interbody fusion (axialif) and posterior instrumentation: a multicenter study
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3787926/
https://www.ncbi.nlm.nih.gov/pubmed/24092998
http://dx.doi.org/10.2147/MDER.S48442
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