NCT02552173

Brief Summary

Investigators prospectively evaluate the accuracy of intraoperative stem anteversion in 40consecutive total hip arthroplasties.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

September 15, 2015

Last Update Submit

March 28, 2016

Conditions

Arthroplasty Total Hip Replacement

Outcome Measures

Primary Outcomes (1)

  • Intraopertive surgeon's estimation and postoperative CT scan were taken to measure stem anteversion

    postoperative 4days

Secondary Outcomes (1)

  • The correlation between stem anteversion of intraopertive surgeon's estimation and stem version postoperative CT scan

    postoperative 4days

Study Arms (1)

stem anteversion

intraoperative surgeon's estimation and postopertive CT sacn were taken to measure stem anteversion

Radiation: The Relationship Between Operative and Radiologic Stem Version

Interventions

The Relationship Between Operative and Radiologic Stem VersionRADIATION

intraopertive surgeon's estimation and postoperative CT scan

stem anteversion

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Between October 2015 and December 2015, 40 consecutive patients who underwent primary cementless total hip arthroplasty agreed to undergo a postoperative computed tomography scan.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national University Bundang Hospital

Seongnam-si, Gyeounggi-do, 463-707, South Korea

Location

Study Officials

  • Kyung-Hoi Koo, professor

    Director, Head of Orthopaedics, Seoul National university Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Orthopaedics, Principal Investigator, Professor

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 17, 2015

Study Start

October 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations

KR(1)