Cargando…
Comparison of clinical and biomechanical outcomes between the kinematic and mechanical alignment methods in total knee arthroplasty: Protocol for a multicenter randomized controlled trial
INTRODUCTION: The concept of anatomic restoration has garnered considerable interest in the form of kinematically aligned total knee arthroplasty (KA-TKA). KA-TKAs have been reported to reproduce natural alignment and kinematics. However, few randomized controlled trials (RCTs) have compared the bio...
Autores principales: | , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8085889/ https://www.ncbi.nlm.nih.gov/pubmed/33981909 http://dx.doi.org/10.1016/j.conctc.2021.100775 |
_version_ | 1783686421279670272 |
---|---|
author | Takashima, Yoshinori Matsumoto, Tomoyuki Takayama, Koji Nakano, Naoki Kuroda, Yuichi Tsubosaka, Masanori Kamenaga, Tomoyuki Kikuchi, Kenichi Fujita, Masahiro Ikuta, Kemmei Anjiki, Kensuke Hayashi, Shinya Hashimoto, Shingo Maeda, Toshihisa Inokuchi, Takao Toda, Mitsunori Chin, Takaaki Kuroda, Ryosuke |
author_facet | Takashima, Yoshinori Matsumoto, Tomoyuki Takayama, Koji Nakano, Naoki Kuroda, Yuichi Tsubosaka, Masanori Kamenaga, Tomoyuki Kikuchi, Kenichi Fujita, Masahiro Ikuta, Kemmei Anjiki, Kensuke Hayashi, Shinya Hashimoto, Shingo Maeda, Toshihisa Inokuchi, Takao Toda, Mitsunori Chin, Takaaki Kuroda, Ryosuke |
author_sort | Takashima, Yoshinori |
collection | PubMed |
description | INTRODUCTION: The concept of anatomic restoration has garnered considerable interest in the form of kinematically aligned total knee arthroplasty (KA-TKA). KA-TKAs have been reported to reproduce natural alignment and kinematics. However, few randomized controlled trials (RCTs) have compared the biomechanical outcomes and the long-term clinical outcomes of KA-TKA with those of mechanically aligned TKA (MA-TKA). We aim to investigate the long-term clinical and biomechanical effects of KA-TKA and to determine whether KA-TKA or MA-TKA is more appropriate for primary TKA. METHODS: This trial will compare clinical and biomechanical outcomes of KA-TKA to those of MA-TKA. Two hundred patients will be enrolled in the RCT and randomized into KA-TKA or MA-TKA groups. Both the groups will be evaluated 1 week before the operation, on the day of the operation, 6 months after the operation, and 1, 5, and 10 years after the operation. The primary outcome is the difference between preoperative and 1-year postoperative functional activity scores of the 2011 Knee Society Score (2011 KSS) in both groups as well as the differences between the scores of both groups. The secondary outcomes will include differences in symptom, satisfaction, and expectation scores of the 2011 KSS, intraoperative kinematics evaluation, postoperative clinical outcomes and complications, pre- and postoperative gait analyses and radiograph evaluations between both KA-TKA and MA-TKA. |
format | Online Article Text |
id | pubmed-8085889 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-80858892021-05-11 Comparison of clinical and biomechanical outcomes between the kinematic and mechanical alignment methods in total knee arthroplasty: Protocol for a multicenter randomized controlled trial Takashima, Yoshinori Matsumoto, Tomoyuki Takayama, Koji Nakano, Naoki Kuroda, Yuichi Tsubosaka, Masanori Kamenaga, Tomoyuki Kikuchi, Kenichi Fujita, Masahiro Ikuta, Kemmei Anjiki, Kensuke Hayashi, Shinya Hashimoto, Shingo Maeda, Toshihisa Inokuchi, Takao Toda, Mitsunori Chin, Takaaki Kuroda, Ryosuke Contemp Clin Trials Commun Article INTRODUCTION: The concept of anatomic restoration has garnered considerable interest in the form of kinematically aligned total knee arthroplasty (KA-TKA). KA-TKAs have been reported to reproduce natural alignment and kinematics. However, few randomized controlled trials (RCTs) have compared the biomechanical outcomes and the long-term clinical outcomes of KA-TKA with those of mechanically aligned TKA (MA-TKA). We aim to investigate the long-term clinical and biomechanical effects of KA-TKA and to determine whether KA-TKA or MA-TKA is more appropriate for primary TKA. METHODS: This trial will compare clinical and biomechanical outcomes of KA-TKA to those of MA-TKA. Two hundred patients will be enrolled in the RCT and randomized into KA-TKA or MA-TKA groups. Both the groups will be evaluated 1 week before the operation, on the day of the operation, 6 months after the operation, and 1, 5, and 10 years after the operation. The primary outcome is the difference between preoperative and 1-year postoperative functional activity scores of the 2011 Knee Society Score (2011 KSS) in both groups as well as the differences between the scores of both groups. The secondary outcomes will include differences in symptom, satisfaction, and expectation scores of the 2011 KSS, intraoperative kinematics evaluation, postoperative clinical outcomes and complications, pre- and postoperative gait analyses and radiograph evaluations between both KA-TKA and MA-TKA. Elsevier 2021-04-15 /pmc/articles/PMC8085889/ /pubmed/33981909 http://dx.doi.org/10.1016/j.conctc.2021.100775 Text en © 2021 Published by Elsevier Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Article Takashima, Yoshinori Matsumoto, Tomoyuki Takayama, Koji Nakano, Naoki Kuroda, Yuichi Tsubosaka, Masanori Kamenaga, Tomoyuki Kikuchi, Kenichi Fujita, Masahiro Ikuta, Kemmei Anjiki, Kensuke Hayashi, Shinya Hashimoto, Shingo Maeda, Toshihisa Inokuchi, Takao Toda, Mitsunori Chin, Takaaki Kuroda, Ryosuke Comparison of clinical and biomechanical outcomes between the kinematic and mechanical alignment methods in total knee arthroplasty: Protocol for a multicenter randomized controlled trial |
title | Comparison of clinical and biomechanical outcomes between the kinematic and mechanical alignment methods in total knee arthroplasty: Protocol for a multicenter randomized controlled trial |
title_full | Comparison of clinical and biomechanical outcomes between the kinematic and mechanical alignment methods in total knee arthroplasty: Protocol for a multicenter randomized controlled trial |
title_fullStr | Comparison of clinical and biomechanical outcomes between the kinematic and mechanical alignment methods in total knee arthroplasty: Protocol for a multicenter randomized controlled trial |
title_full_unstemmed | Comparison of clinical and biomechanical outcomes between the kinematic and mechanical alignment methods in total knee arthroplasty: Protocol for a multicenter randomized controlled trial |
title_short | Comparison of clinical and biomechanical outcomes between the kinematic and mechanical alignment methods in total knee arthroplasty: Protocol for a multicenter randomized controlled trial |
title_sort | comparison of clinical and biomechanical outcomes between the kinematic and mechanical alignment methods in total knee arthroplasty: protocol for a multicenter randomized controlled trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8085889/ https://www.ncbi.nlm.nih.gov/pubmed/33981909 http://dx.doi.org/10.1016/j.conctc.2021.100775 |
work_keys_str_mv | AT takashimayoshinori comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT matsumototomoyuki comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT takayamakoji comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT nakanonaoki comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT kurodayuichi comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT tsubosakamasanori comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT kamenagatomoyuki comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT kikuchikenichi comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT fujitamasahiro comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT ikutakemmei comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT anjikikensuke comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT hayashishinya comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT hashimotoshingo comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT maedatoshihisa comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT inokuchitakao comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT todamitsunori comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT chintakaaki comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial AT kurodaryosuke comparisonofclinicalandbiomechanicaloutcomesbetweenthekinematicandmechanicalalignmentmethodsintotalkneearthroplastyprotocolforamulticenterrandomizedcontrolledtrial |