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Clinical performance of an elastomeric lumbar disc replacement: Minimum 12 months follow-up
BACKGROUND: Elastomeric disc replacements have been developed to restore normal shock absorption and physiologic centers of rotation to the degenerated disc. The Physio-L Artificial Lumbar Disc is an elastomeric disc which uses a compliant polycarbonate-polyurethane core with enhanced endurance prop...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier, Inc.
2010
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4365609/ https://www.ncbi.nlm.nih.gov/pubmed/25802645 http://dx.doi.org/10.1016/j.esas.2009.12.002 |
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author | Pimenta, Luiz Springmuller, Raul Lee, Casey K. Oliveira, Leonardo Roth, Sandra E. Ogilvie, William F. |
author_facet | Pimenta, Luiz Springmuller, Raul Lee, Casey K. Oliveira, Leonardo Roth, Sandra E. Ogilvie, William F. |
author_sort | Pimenta, Luiz |
collection | PubMed |
description | BACKGROUND: Elastomeric disc replacements have been developed to restore normal shock absorption and physiologic centers of rotation to the degenerated disc. The Physio-L Artificial Lumbar Disc is an elastomeric disc which uses a compliant polycarbonate-polyurethane core with enhanced endurance properties. The objective of this study was to evaluate the safety and efficacy of the Physio-L through a 12-month follow-up period in a prospective, nonrandomized clinical trial. METHODS: Twelve patients who met the inclusion/exclusion criteria were enrolled in the study. Eight patients received a single implant (L5-S1) and 4 received a 2-level implantation (L4-5 and L5-S1). Patients were assessed preoperatively and postoperatively at 6 weeks and 3, 6, and 12 months. Primary outcomes included the VAS, ODI, a radiographic analysis of implant condition, incidence of major complications, and reoperations. Secondary outcomes included SF-36, ROM at index and adjacent levels and disc height. RESULTS: All patients completed the 12-month follow-up evaluations. Through 12 months, the Physio-L devices have remained intact with no evidence of subsidence, migration, or expulsion. VAS low-back pain and ODI scores improved significantly at all follow-up periods compared to preoperative scores. The range of motion of 13.3° ± 5.5° at the index level was considered normal. Overall, patients were satisfied with an average score of 83.5 ± 26.8 mm. When comparing the device to other artificial discs, the current device showed a clinically relevant improvement in both ODI and VAS scores at all follow-up time points. Statistically significant improvements in both scores were observed at 12 months (P < .05). CONCLUSION: The Physio-L is safe and efficacious, as demonstrated by improved pain relief and functional recovery without any implant failures, significant device related complications, or adverse incidents. The clinical results for VAS and ODI were superior to other marketed artificial lumbar discs such as the Charité and ProDisc-L at the same follow-up timeframes. |
format | Online Article Text |
id | pubmed-4365609 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | Elsevier, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-43656092015-03-23 Clinical performance of an elastomeric lumbar disc replacement: Minimum 12 months follow-up Pimenta, Luiz Springmuller, Raul Lee, Casey K. Oliveira, Leonardo Roth, Sandra E. Ogilvie, William F. SAS J Lumbar Arthroplasty BACKGROUND: Elastomeric disc replacements have been developed to restore normal shock absorption and physiologic centers of rotation to the degenerated disc. The Physio-L Artificial Lumbar Disc is an elastomeric disc which uses a compliant polycarbonate-polyurethane core with enhanced endurance properties. The objective of this study was to evaluate the safety and efficacy of the Physio-L through a 12-month follow-up period in a prospective, nonrandomized clinical trial. METHODS: Twelve patients who met the inclusion/exclusion criteria were enrolled in the study. Eight patients received a single implant (L5-S1) and 4 received a 2-level implantation (L4-5 and L5-S1). Patients were assessed preoperatively and postoperatively at 6 weeks and 3, 6, and 12 months. Primary outcomes included the VAS, ODI, a radiographic analysis of implant condition, incidence of major complications, and reoperations. Secondary outcomes included SF-36, ROM at index and adjacent levels and disc height. RESULTS: All patients completed the 12-month follow-up evaluations. Through 12 months, the Physio-L devices have remained intact with no evidence of subsidence, migration, or expulsion. VAS low-back pain and ODI scores improved significantly at all follow-up periods compared to preoperative scores. The range of motion of 13.3° ± 5.5° at the index level was considered normal. Overall, patients were satisfied with an average score of 83.5 ± 26.8 mm. When comparing the device to other artificial discs, the current device showed a clinically relevant improvement in both ODI and VAS scores at all follow-up time points. Statistically significant improvements in both scores were observed at 12 months (P < .05). CONCLUSION: The Physio-L is safe and efficacious, as demonstrated by improved pain relief and functional recovery without any implant failures, significant device related complications, or adverse incidents. The clinical results for VAS and ODI were superior to other marketed artificial lumbar discs such as the Charité and ProDisc-L at the same follow-up timeframes. Elsevier, Inc. 2010-03-01 /pmc/articles/PMC4365609/ /pubmed/25802645 http://dx.doi.org/10.1016/j.esas.2009.12.002 Text en © 2010 SAS - The International Society for the Advancement of Spine Surgery. Published by Elsevier Inc. All rights reserved. http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-Noncommercial 3.0 Unported License, permitting all non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Lumbar Arthroplasty Pimenta, Luiz Springmuller, Raul Lee, Casey K. Oliveira, Leonardo Roth, Sandra E. Ogilvie, William F. Clinical performance of an elastomeric lumbar disc replacement: Minimum 12 months follow-up |
title | Clinical performance of an elastomeric lumbar disc replacement: Minimum 12 months follow-up |
title_full | Clinical performance of an elastomeric lumbar disc replacement: Minimum 12 months follow-up |
title_fullStr | Clinical performance of an elastomeric lumbar disc replacement: Minimum 12 months follow-up |
title_full_unstemmed | Clinical performance of an elastomeric lumbar disc replacement: Minimum 12 months follow-up |
title_short | Clinical performance of an elastomeric lumbar disc replacement: Minimum 12 months follow-up |
title_sort | clinical performance of an elastomeric lumbar disc replacement: minimum 12 months follow-up |
topic | Lumbar Arthroplasty |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4365609/ https://www.ncbi.nlm.nih.gov/pubmed/25802645 http://dx.doi.org/10.1016/j.esas.2009.12.002 |
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