Prosthesis Loosening Imaging With Dual Energy and Tomosynthesis (PLIDET)

August 17, 2016 updated by: Central Hospital, Nancy, France

Study of Diagnostic Performances of Dual Energy Imaging With Flat Detectors and Tomosynthesis in Identification of Loosening of Painful Hip Prosthesis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hip arthroplasty has become one of the most performed orthopedic procedures. Actual average lifetime of total hip prosthesis is approximately 15 years. Some complications are inevitable. Total hip prosthesis imaging, performed to search for a complication or wear, is difficult and depends on many techniques. Subtracted arthrography is a good technique but its access is limited because it needs an angiography room.

In this study patients undergo standard arthrography, dual energy arthrography, arthro-tomosynthesis and arthro-tomography.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

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

  • France
      • Nancy, France
        • CHU de Nancy
      • Nancy, France
        • SINCAL

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients sent for arthro-tomography of painful prosthesis, without contraindications to arthrography or injection of contrast agent
  • Aware and cooperative
  • Signed informed consent
  • Affiliation to social security

Exclusion Criteria:

  • Any contraindication to arthrography or injection of contrast agent
  • Pregnant or possibly pregnant women
  • Patient under guardianship
  • Refusal or impossibility of informed consent

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with painful prosthesis
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence or absence of prosthesis loosening detected with 3 radiographic techniques (dual-energy arthrography, arthro-tomosynthesis and single-energy tomography) and surgery
Time Frame: from day 0 up to 6 months

Gold standard is presence or absence of prosthesis loosening revealed with surgery performed after 6 months from arthrography.

Data of patients undergone surgery and not are collected and analyzed. Any clinical or imagery sign of loosening in non-operated patient, will be classified as loosening. A surgery decision for suspicion of loosening will be considered loosening.
from day 0 up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison between density differential between 2 acquisitions and grey level on subtraction
Time Frame: day 0
day 0

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Alain Blum, Service d'Imagerie Guilloz - CHU Nancy - France

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

July 1, 2012

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (ESTIMATE)

August 22, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 22, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2011-A00677-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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