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

Arthroplasty Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554149
• Other study ID #: Ante-001
• Status: Completed
• Phase: N/A
• First received: September 15, 2015
• Last updated: March 28, 2016
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study was to develop a radiological method to measure stem anteversion and to determine its validity and reliability.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthroplasty
• Total Hip Replacement

Intervention

Radiation:
• Radiological measurement of femoral stem version
particular radiographs( lateral decubitus view) and CT scans

Locations

Country	Name	City	State
Korea, Republic of	Seoul national University Bundang Hospital	Seongnam-Si	Gyeounggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stem anteversion of the hip radiograph(decubitus lateral view)		postoperative 4days	Yes
Primary	stem anteversion of the CT scan		postoperative 4days	Yes
Secondary	The correlation between stem anteversion of the decubitus lateral view and stem version of the CT scan	to determine ICC(intraclass coefficient, correlation coefficient)	postoperative 4days	Yes