Radiological Measurement of Femoral Stem Version Using Lateral Decubitus Method: A Prospective Study

March 28, 2016 updated by: Kyung-Hoi Koo, Seoul National University Bundang Hospital
The purpose of this study was to develop a radiological method to measure stem anteversion and to determine its validity and reliability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Version of the femoral stem is an important factor influencing the risk of dislocation after total hip replacement (THR) as well as the position of the acetabular component. However, there is no radiological method of measuring stem anteversion described in the literature. Investigators propose a radiological method to measure stem version and have assessed its reliability and validity. In 40 patients who underwent THR, a hip radiograph and CT scan were taken to measure stem anteversion.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeounggi-do
      • Seongnam-Si, Gyeounggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients who underwent THR between October 2015 and December 2015

Description

Inclusion Criteria:

  • Investigators recruited 40 consecutive patients who underwent THR between October 2015 and December 2015

Exclusion Criteria:

  • patients who could not extend the hip because of a residual flexion contracture.
  • who had a flexion contracture of the knee or who could not flex the hip to 90° even after THR were excluded because participants could not adopt the posture required for the particular radiographs and CT scans.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
stem anteversion
a hip lateral radiograph and CT scan were taken to measure stem anteversion
Radiation: Radiological measurement of femoral stem version
particular radiographs( lateral decubitus view) and CT scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stem anteversion of the hip radiograph(decubitus lateral view)
Time Frame: postoperative 4days
postoperative 4days
stem anteversion of the CT scan
Time Frame: postoperative 4days
postoperative 4days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation between stem anteversion of the decubitus lateral view and stem version of the CT scan
Time Frame: postoperative 4days
to determine ICC(intraclass coefficient, correlation coefficient)
postoperative 4days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Kyung-Hoi Koo, professor, Director, Head of Orthopaedics, Seoul National university Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Ante-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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