Measurement and Quantitative Correlation of Spinopelvic Parameters and Acetabular Cup Orientation Between Standing and Sitting to Define a Better Functional Anteversion Safe Zone in Total Hip Arthroplasty
Sponsor study identifier
observational
37
1 country
1
Study Start
February 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2018
Actual (reported)Study Completion
October 2018
Actual (reported)In total hip arthroplasty, cup anteversion is an important factor in stability. Lewinnek's safe zone and functional anteversion are often used to assess appropriate orientation. However, these approaches do not consider the effect of the spinopelvic chain and lumbar mobility when in the seated position. This study will measure functional anteversion when standing and sitting with patient-specific computer models and define a quantitative relationship between the change in functional anteversion and spinopelvic parameters. This will challenge the historical paradigm of the safe zone and provide a tool to define anteversion based on a patient's mechanics and reduce risk of dislocation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 5, 2015
Actual (reported)November 6, 2015
Actual (reported)February 2016
Date type not reportedThis date has not been verified as actual or estimated.
October 2018
Actual (reported)October 2018
Actual (reported)Quantitative correlation between change functional anteversion and change in pelvic tilt using patient-specific measurements and computer models.
A quantitative relationship will be generated correlating change in cup anteversion (change in degrees) to change in pelvic tilt (change in degrees) at given inclinations (degrees) as simulated in the model. Statistical analysis will then be performed. Significance of changes between standing and sitting in pelvic tilt and cup anteversion will be assessed with t-test or non-parametric equivalent if appropriate with significance p\<0.05. The effect of change in pelvic tilt on change in functional anteversion will be tested using a two-tailed Pearson product moment.
1 year
Quantitative correlation between change functional anteversion and change in lumbar lordosis using patient-specific measurements and computer models.
A quantitative relationship will be generated correlating change in cup anteversion (change in degrees) to change in lumbar lordosis (change in degrees). Statistical analysis will then be performed. Significance of changes between standing and sitting in lumbar lordosis and cup anteversion will be assessed with t-test or non-parametric equivalent if appropriate with significance p\<0.05. The effect of change in lumbar lordosis on change in functional anteversion will be tested using a two-tailed Pearson product moment.
1 year
Presence of lumbar pathology
1 year
Previous lumbar surgery - fusion type
1 year
Previous lumbar surgery - length of fusion
1 year
Total hip arthroplasty dislocation
1 year
Other total hip arthroplasty complication
1 year
All patients who have undergone THA with the appropriate pre-operative CT for planning and those who are candidates for primary THA for osteoarthritis will be contacted for recruitment. Those with inflammatory arthritides or neuromuscular disorders will not be eligible for the study. Women of childbearing age will also be excluded from this study. Base on the power analysis below, the investigators anticipate eighty-four (84) patients will be enrolled into this study.
Duke Medical Plaza Page Road
Durham, North Carolina, 27703, United States
Thorsten Seyler, MD
Duke University
37 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2015
First Posted
November 6, 2015
Study Start
February 2016
Date type not reportedThis date has not been verified as actual or estimated.
Analysis of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component
Contact the study team to confirm eligibility.
Primary Completion
October 2018
Actual (reported)Study Completion
October 2018
Actual (reported)Last Updated
June 7, 2019
Record last verified: 2019-06
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Source: ClinicalTrials.gov.
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