Cargando…
Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial
BACKGROUND: The 360° fusion of lumbar segments is a common and well-researched therapy to treat various diseases of the spine. But it changes the biomechanics of the spine and may cause adjacent segment disease (ASD). Among the many techniques developed to avoid this complication, one appears promis...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4161882/ https://www.ncbi.nlm.nih.gov/pubmed/25189113 http://dx.doi.org/10.1186/1471-2474-15-294 |
_version_ | 1782334613480275968 |
---|---|
author | Siewe, Jan Bredow, Jan Oppermann, Johannes Koy, Timmo Delank, Stefan Knoell, Peter Eysel, Peer Sobottke, Rolf Zarghooni, Kourosh Röllinghoff, Marc |
author_facet | Siewe, Jan Bredow, Jan Oppermann, Johannes Koy, Timmo Delank, Stefan Knoell, Peter Eysel, Peer Sobottke, Rolf Zarghooni, Kourosh Röllinghoff, Marc |
author_sort | Siewe, Jan |
collection | PubMed |
description | BACKGROUND: The 360° fusion of lumbar segments is a common and well-researched therapy to treat various diseases of the spine. But it changes the biomechanics of the spine and may cause adjacent segment disease (ASD). Among the many techniques developed to avoid this complication, one appears promising. It combines a rigid fusion with a flexible pedicle screw system (hybrid instrumentation, “topping off”). However, its clinical significance is still uncertain due to the lack of conclusive data. METHODS/DESIGN: The study is a randomized, therapy-controlled, two-centre trial conducted in a clinical setting at two university hospitals. If they meet the criteria, outpatients presenting with degenerative disc disease, facet joint arthrosis or spondylolisthesis will be included in the study and randomized into two groups: a control group undergoing conventional fusion surgery (PLIF - posterior lumbar intervertebral fusion), and an intervention group undergoing fusion surgery using a new flexible pedicle screw system (PLIF + “topping off”), which was brought on the market in 2013. Follow-up examination will take place immediately after surgery, after 6 weeks and after 6, 12, 24 and 36 months. An ongoing assessment will be performed every year. Outcome measurements will include quality of life and pain assessments using validated questionnaires (ODI - Ostwestry Disability Index, SF-36™ - Short Form Health Survey 36, COMI - Core Outcome Measure Index). In addition, clinical and radiologic ASD, sagittal balance parameters and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications (e.g. implant failure), adverse events, and serious adverse events will be monitored and documented throughout the study. DISCUSSION: New hybrid “topping off” systems might improve the outcome of lumbar spine fusion. But to date, there is a serious lack of and a great need of convincing data on safety or efficacy, including benefits and harms to the patients, of these systems. Health care providers are particularly interested in such data as these implants are much more expensive than conventional implants. In such a case, randomized clinical trials are the best way to evaluate benefits and risks. TRIAL REGISTRATION: NCT01852526 |
format | Online Article Text |
id | pubmed-4161882 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-41618822014-09-13 Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial Siewe, Jan Bredow, Jan Oppermann, Johannes Koy, Timmo Delank, Stefan Knoell, Peter Eysel, Peer Sobottke, Rolf Zarghooni, Kourosh Röllinghoff, Marc BMC Musculoskelet Disord Study Protocol BACKGROUND: The 360° fusion of lumbar segments is a common and well-researched therapy to treat various diseases of the spine. But it changes the biomechanics of the spine and may cause adjacent segment disease (ASD). Among the many techniques developed to avoid this complication, one appears promising. It combines a rigid fusion with a flexible pedicle screw system (hybrid instrumentation, “topping off”). However, its clinical significance is still uncertain due to the lack of conclusive data. METHODS/DESIGN: The study is a randomized, therapy-controlled, two-centre trial conducted in a clinical setting at two university hospitals. If they meet the criteria, outpatients presenting with degenerative disc disease, facet joint arthrosis or spondylolisthesis will be included in the study and randomized into two groups: a control group undergoing conventional fusion surgery (PLIF - posterior lumbar intervertebral fusion), and an intervention group undergoing fusion surgery using a new flexible pedicle screw system (PLIF + “topping off”), which was brought on the market in 2013. Follow-up examination will take place immediately after surgery, after 6 weeks and after 6, 12, 24 and 36 months. An ongoing assessment will be performed every year. Outcome measurements will include quality of life and pain assessments using validated questionnaires (ODI - Ostwestry Disability Index, SF-36™ - Short Form Health Survey 36, COMI - Core Outcome Measure Index). In addition, clinical and radiologic ASD, sagittal balance parameters and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications (e.g. implant failure), adverse events, and serious adverse events will be monitored and documented throughout the study. DISCUSSION: New hybrid “topping off” systems might improve the outcome of lumbar spine fusion. But to date, there is a serious lack of and a great need of convincing data on safety or efficacy, including benefits and harms to the patients, of these systems. Health care providers are particularly interested in such data as these implants are much more expensive than conventional implants. In such a case, randomized clinical trials are the best way to evaluate benefits and risks. TRIAL REGISTRATION: NCT01852526 BioMed Central 2014-09-05 /pmc/articles/PMC4161882/ /pubmed/25189113 http://dx.doi.org/10.1186/1471-2474-15-294 Text en © Siewe et al.; licensee BioMed Central Ltd. 2014 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. |
spellingShingle | Study Protocol Siewe, Jan Bredow, Jan Oppermann, Johannes Koy, Timmo Delank, Stefan Knoell, Peter Eysel, Peer Sobottke, Rolf Zarghooni, Kourosh Röllinghoff, Marc Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial |
title | Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial |
title_full | Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial |
title_fullStr | Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial |
title_full_unstemmed | Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial |
title_short | Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial |
title_sort | evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4161882/ https://www.ncbi.nlm.nih.gov/pubmed/25189113 http://dx.doi.org/10.1186/1471-2474-15-294 |
work_keys_str_mv | AT siewejan evaluationofefficacyofanewhybridfusiondevicearandomizedtwocentrecontrolledtrial AT bredowjan evaluationofefficacyofanewhybridfusiondevicearandomizedtwocentrecontrolledtrial AT oppermannjohannes evaluationofefficacyofanewhybridfusiondevicearandomizedtwocentrecontrolledtrial AT koytimmo evaluationofefficacyofanewhybridfusiondevicearandomizedtwocentrecontrolledtrial AT delankstefan evaluationofefficacyofanewhybridfusiondevicearandomizedtwocentrecontrolledtrial AT knoellpeter evaluationofefficacyofanewhybridfusiondevicearandomizedtwocentrecontrolledtrial AT eyselpeer evaluationofefficacyofanewhybridfusiondevicearandomizedtwocentrecontrolledtrial AT sobottkerolf evaluationofefficacyofanewhybridfusiondevicearandomizedtwocentrecontrolledtrial AT zarghoonikourosh evaluationofefficacyofanewhybridfusiondevicearandomizedtwocentrecontrolledtrial AT rollinghoffmarc evaluationofefficacyofanewhybridfusiondevicearandomizedtwocentrecontrolledtrial |