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Prosthesis Loosening Imaging With Dual Energy and Tomosynthesis

NCT02874196 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2016-08-22

No results posted yet for this study

Summary

The purpose is to determine diagnostic performances of flat panel dual energy arthrography and arthro-tomosynthesis in identification of loosening of painful hip prosthesis, taking as reference the results of surgery performed 6 months after arthrography.

Secondary purposes are:

* To describe the level of concordance of each technique with the indication for surgery
* To study inter-technique concordance with kappa coefficient
* To study the relationship between density differential between 2 acquisitions and grey level on subtraction, i.e. subtraction quality according to metal

Conditions

  • Hip Prosthesis Imaging

Interventions

PROCEDURE

Standard arthrography

PROCEDURE

Dual energy arthrography

PROCEDURE

Arthro-tomosynthesis

PROCEDURE

Arthro-tomography

PROCEDURE

Surgery on painful prosthesis

Possibly performed during 6 months from arthrography

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Alain Blum · Service d'Imagerie Guilloz - CHU Nancy - France

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02874196 on ClinicalTrials.gov