Prosthesis Loosening Imaging With Dual Energy and Tomosynthesis

Not Applicable

Completed

• Conditions: Hip Prosthesis Imaging
• Interventions: Procedure: Standard arthrography; Procedure: Dual energy arthrography; Procedure: Arthro-tomosynthesis; Procedure: Arthro-tomography; Procedure: Surgery on painful prosthesis

• Registration Number: NCT02874196
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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

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 Timeline

• Study Start: 2012-07
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-08
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-17
• Last Update Submitted: 2016-08-17
• Study First Posted: 2016-08-22
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with painful prosthesis	Arthro-tomography	-
Patients with painful prosthesis	Surgery on painful prosthesis	-
Patients with painful prosthesis	Standard arthrography	-
Patients with painful prosthesis	Arthro-tomosynthesis	-
Patients with painful prosthesis	Dual energy arthrography	-

Primary Outcome Measures

Name	Time	Method
Presence or absence of prosthesis loosening detected with 3 radiographic techniques (dual-energy arthrography, arthro-tomosynthesis and single-energy tomography) and surgery	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.

Secondary Outcome Measures

Name	Time	Method
Comparison between density differential between 2 acquisitions and grey level on subtraction	day 0

Trial Locations

Locations (2)

SINCAL; 🇫🇷 Nancy, France

CHU de Nancy; 🇫🇷 Nancy, France