A blinded, three-arm randomised trial assessing joint function and measuring three-dimensional knee joint kinematics in individuals six months after a total knee joint replacement; comparing a medially stabilised design, to standard fixed bearing conventional designs – posterior stabilising and cruciate retaining
Background: No randomised trial exists to assess the relative prosthetic performance of three fixed bearing total knee joint replacement construct designs through clinical functional outcomes and biomechanical gait analysis at six months after the index procedure. Methods: The design of a double bli...
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Published in | International Journal of Clinical Trials Vol. 5; no. 1; p. 37 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
Published |
23.01.2018
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Online Access | Get full text |
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Abstract | Background: No randomised trial exists to assess the relative prosthetic performance of three fixed bearing total knee joint replacement construct designs through clinical functional outcomes and biomechanical gait analysis at six months after the index procedure.
Methods: The design of a double blinded, prospective, randomised trial with three parallel patient groups is presented. Patients reviewed in consultant clinic with radiographic and clinical diagnosis of osteoarthritis of the knee, with the condition deemed severe enough to require a total knee joint replacement (TKJR) are eligible. Subjects enrolled in the trial are randomised to one of the three TKJR construct designs approximately ten days prior to scheduled date of surgery. Each subject is then followed up for at least twelve months. Repeated measure of Analysis of Variance (ANOVA), and Analysis of Covariance (ANCOVA) will be utilised to uncover any clinical functional differences in each trial group in each time interval.
Results: Differences in clinical functional scores at each time interval compared to pre-intervention, as well as between group differences in clinical functional scores at each time interval will be examined. At six months after the operation, biomechanical measurements of joint motion, ground reaction forces, and muscle electromyographic (EMG) activity will be recorded simultaneously from each subject for four test conditions: level walking, stair ascent, stair descent, and chair rise.
Conclusions: This randomised trial is designed to better understand the relationships between the clinical functional outcomes and replaced knee kinematics in three fixed bearing total knee replacement construct designs at six months postoperatively. |
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AbstractList | Background: No randomised trial exists to assess the relative prosthetic performance of three fixed bearing total knee joint replacement construct designs through clinical functional outcomes and biomechanical gait analysis at six months after the index procedure.
Methods: The design of a double blinded, prospective, randomised trial with three parallel patient groups is presented. Patients reviewed in consultant clinic with radiographic and clinical diagnosis of osteoarthritis of the knee, with the condition deemed severe enough to require a total knee joint replacement (TKJR) are eligible. Subjects enrolled in the trial are randomised to one of the three TKJR construct designs approximately ten days prior to scheduled date of surgery. Each subject is then followed up for at least twelve months. Repeated measure of Analysis of Variance (ANOVA), and Analysis of Covariance (ANCOVA) will be utilised to uncover any clinical functional differences in each trial group in each time interval.
Results: Differences in clinical functional scores at each time interval compared to pre-intervention, as well as between group differences in clinical functional scores at each time interval will be examined. At six months after the operation, biomechanical measurements of joint motion, ground reaction forces, and muscle electromyographic (EMG) activity will be recorded simultaneously from each subject for four test conditions: level walking, stair ascent, stair descent, and chair rise.
Conclusions: This randomised trial is designed to better understand the relationships between the clinical functional outcomes and replaced knee kinematics in three fixed bearing total knee replacement construct designs at six months postoperatively. |
Author | Pandy, Marcus Young, Tony J. Gray, Hans Dowsey, Michelle M. Guan, Shangyuanye Choong, Peter F. |
Author_xml | – sequence: 1 givenname: Michelle M. surname: Dowsey fullname: Dowsey, Michelle M. – sequence: 2 givenname: Marcus surname: Pandy fullname: Pandy, Marcus – sequence: 3 givenname: Tony J. orcidid: 0000-0001-9519-9195 surname: Young fullname: Young, Tony J. – sequence: 4 givenname: Hans surname: Gray fullname: Gray, Hans – sequence: 5 givenname: Shangyuanye surname: Guan fullname: Guan, Shangyuanye – sequence: 6 givenname: Peter F. surname: Choong fullname: Choong, Peter F. |
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CitedBy_id | crossref_primary_10_3389_fsurg_2018_00025 crossref_primary_10_1016_j_arth_2020_01_085 crossref_primary_10_1002_jor_24613 |
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Title | A blinded, three-arm randomised trial assessing joint function and measuring three-dimensional knee joint kinematics in individuals six months after a total knee joint replacement; comparing a medially stabilised design, to standard fixed bearing conventional designs – posterior stabilising and cruciate retaining |
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