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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02598700
Other study ID # Pro00066248
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2016
Est. completion date October 2018

Study information

Verified date June 2019
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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Study Design


Locations

Country Name City State
United States Duke Medical Plaza Page Road Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary Presence of lumbar pathology degenerative disc disease, posterior degenerative disease, osteophytosis, ankylosing spondylitis, scoliosis, or flat back syndrome 1 year
Secondary Previous lumbar surgery - fusion type posterior, anterior, or combined 1 year
Secondary Previous lumbar surgery - length of fusion number of fusion levels 1 year
Secondary Total hip arthroplasty dislocation presence of dislocation 1 year
Secondary Other total hip arthroplasty complication loosening, fracture, or infection 1 year
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