Radiological Measurement of Femoral Stem Version Using La... | NCT02554149

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

NCT02554149

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Mar 29, 2016Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Arthroplasty
Total Hip Replacement

Interventions

Radiological measurement of femoral stem version

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Sep 15, 2015

First Submission Date that Met QC Criteria

Sep 17, 2015

First Posted Date

Sep 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2016

Last Update Posted Date

Mar 29, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kyung-Hoi Koo, Director, Head of Orthopaedics, Principal Investigator, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
stem anteversion		a hip lateral radiograph and CT scan were taken to measure stem anteversion	Radiation: Radiological measurement of femoral stem version

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiological measurement of femoral stem version	Radiation	particular radiographs( lateral decubitus view) and CT scans	stem anteversion

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients who underwent THR between October 2015 and December 2015

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyung-Hoi Koo, professor	Director, Head of Orthopaedics, Seoul National university Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul national University Bundang Hospital		Seongnam-si	Gyeounggi-do	463-707	South Korea