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Nexus Evaluation Primary Trident II UNcemented shEll (NEPTUNE): a longitudinal cohort study of the hydroxyapatite coated Trident II acetabular system in total hip arthroplasty
AIMS: The primary aim of this study is to assess the survival of the uncemented hydroxyapatite (HA) coated Trident II acetabular component as part of a hybrid total hip arthroplasty (THA) using a cemented Exeter stem. The secondary aims are to assess the complications, joint-specific function, healt...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The British Editorial Society of Bone & Joint Surgery
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10581835/ https://www.ncbi.nlm.nih.gov/pubmed/37848192 http://dx.doi.org/10.1302/2633-1462.410.BJO-2023-0052 |
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author | Hamilton, David F. Gaston, Paul Macpherson, Gavin J. Simpson, Philip Clement, Nick D. |
author_facet | Hamilton, David F. Gaston, Paul Macpherson, Gavin J. Simpson, Philip Clement, Nick D. |
author_sort | Hamilton, David F. |
collection | PubMed |
description | AIMS: The primary aim of this study is to assess the survival of the uncemented hydroxyapatite (HA) coated Trident II acetabular component as part of a hybrid total hip arthroplasty (THA) using a cemented Exeter stem. The secondary aims are to assess the complications, joint-specific function, health-related quality of life, and radiological signs of loosening of the acetabular component. METHODS: A single-centre, prospective cohort study of 125 implants will be undertaken. Patients undergoing hybrid THA at the study centre will be recruited. Inclusion criteria are patients suitable for the use of the uncemented acetabular component, aged 18 to 75 years, willing and able to comply with the study protocol, and provide informed consent. Exclusion criteria includes patients not meeting study inclusion criteria, inadequate bone stock to support fixation of the prosthesis, a BMI > 40 kg/m(2), or THA performed for pain relief in those with severely restricted mobility. RESULTS: Implant survival, complications, functional outcomes and radiological assessment up to ten years following index THA (one, two, five, seven, and ten years) will be performed. Functional assessment will include the Oxford Hip Score, Forgotten Joint Score, 12-Item Short Form Health Survey, EuroQol five-dimension health questionnaire, and pain and patient satisfaction. Radiological assessment with assess for acetabula lucent lines, lysis, and loosening according to DeLee and Charnley zones. CONCLUSION: This study is part of a stepwise introduction of a new device to orthopaedic practice, and careful monitoring of implants should be carried out as part of the Beyond Compliance principles. The results of this study will provide functional, radiological, and survival data to either support the ongoing use of the HA acetabulum or highlight potential limitations of this new implant before wide adoption. Cite this article: Bone Jt Open 2023;4(10):782–790. |
format | Online Article Text |
id | pubmed-10581835 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | The British Editorial Society of Bone & Joint Surgery |
record_format | MEDLINE/PubMed |
spelling | pubmed-105818352023-10-18 Nexus Evaluation Primary Trident II UNcemented shEll (NEPTUNE): a longitudinal cohort study of the hydroxyapatite coated Trident II acetabular system in total hip arthroplasty Hamilton, David F. Gaston, Paul Macpherson, Gavin J. Simpson, Philip Clement, Nick D. Bone Jt Open Protocol AIMS: The primary aim of this study is to assess the survival of the uncemented hydroxyapatite (HA) coated Trident II acetabular component as part of a hybrid total hip arthroplasty (THA) using a cemented Exeter stem. The secondary aims are to assess the complications, joint-specific function, health-related quality of life, and radiological signs of loosening of the acetabular component. METHODS: A single-centre, prospective cohort study of 125 implants will be undertaken. Patients undergoing hybrid THA at the study centre will be recruited. Inclusion criteria are patients suitable for the use of the uncemented acetabular component, aged 18 to 75 years, willing and able to comply with the study protocol, and provide informed consent. Exclusion criteria includes patients not meeting study inclusion criteria, inadequate bone stock to support fixation of the prosthesis, a BMI > 40 kg/m(2), or THA performed for pain relief in those with severely restricted mobility. RESULTS: Implant survival, complications, functional outcomes and radiological assessment up to ten years following index THA (one, two, five, seven, and ten years) will be performed. Functional assessment will include the Oxford Hip Score, Forgotten Joint Score, 12-Item Short Form Health Survey, EuroQol five-dimension health questionnaire, and pain and patient satisfaction. Radiological assessment with assess for acetabula lucent lines, lysis, and loosening according to DeLee and Charnley zones. CONCLUSION: This study is part of a stepwise introduction of a new device to orthopaedic practice, and careful monitoring of implants should be carried out as part of the Beyond Compliance principles. The results of this study will provide functional, radiological, and survival data to either support the ongoing use of the HA acetabulum or highlight potential limitations of this new implant before wide adoption. Cite this article: Bone Jt Open 2023;4(10):782–790. The British Editorial Society of Bone & Joint Surgery 2023-10-18 /pmc/articles/PMC10581835/ /pubmed/37848192 http://dx.doi.org/10.1302/2633-1462.410.BJO-2023-0052 Text en © 2023 Hamilton et al. https://creativecommons.org/licenses/by-nc-nd/4.0/https://online.boneandjoint.org.uk/TDMThis is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (CC BY-NC-ND 4.0) licence, which permits the copying and redistribution of the work only, and provided the original author and source are credited. See https://creativecommons.org/licenses/by-nc-nd/4.0/ |
spellingShingle | Protocol Hamilton, David F. Gaston, Paul Macpherson, Gavin J. Simpson, Philip Clement, Nick D. Nexus Evaluation Primary Trident II UNcemented shEll (NEPTUNE): a longitudinal cohort study of the hydroxyapatite coated Trident II acetabular system in total hip arthroplasty |
title | Nexus Evaluation Primary Trident II UNcemented shEll (NEPTUNE): a longitudinal cohort study of the hydroxyapatite coated Trident II acetabular system in total hip arthroplasty |
title_full | Nexus Evaluation Primary Trident II UNcemented shEll (NEPTUNE): a longitudinal cohort study of the hydroxyapatite coated Trident II acetabular system in total hip arthroplasty |
title_fullStr | Nexus Evaluation Primary Trident II UNcemented shEll (NEPTUNE): a longitudinal cohort study of the hydroxyapatite coated Trident II acetabular system in total hip arthroplasty |
title_full_unstemmed | Nexus Evaluation Primary Trident II UNcemented shEll (NEPTUNE): a longitudinal cohort study of the hydroxyapatite coated Trident II acetabular system in total hip arthroplasty |
title_short | Nexus Evaluation Primary Trident II UNcemented shEll (NEPTUNE): a longitudinal cohort study of the hydroxyapatite coated Trident II acetabular system in total hip arthroplasty |
title_sort | nexus evaluation primary trident ii uncemented shell (neptune): a longitudinal cohort study of the hydroxyapatite coated trident ii acetabular system in total hip arthroplasty |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10581835/ https://www.ncbi.nlm.nih.gov/pubmed/37848192 http://dx.doi.org/10.1302/2633-1462.410.BJO-2023-0052 |
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