Prosthesis Loosening Imaging With Dual Energy and Tomosynthesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-09-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Hip Prosthesis Imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with painful prosthesis

Group Type EXPERIMENTAL

Standard arthrography

Intervention Type PROCEDURE

Dual energy arthrography

Intervention Type PROCEDURE

Arthro-tomosynthesis

Intervention Type PROCEDURE

Arthro-tomography

Intervention Type PROCEDURE

Surgery on painful prosthesis

Intervention Type PROCEDURE

Possibly performed during 6 months from arthrography

Interventions

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Standard arthrography

Intervention Type PROCEDURE

Dual energy arthrography

Intervention Type PROCEDURE

Arthro-tomosynthesis

Intervention Type PROCEDURE

Arthro-tomography

Intervention Type PROCEDURE

Surgery on painful prosthesis

Possibly performed during 6 months from arthrography

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No