Prosthesis Loosening Imaging With Dual Energy and Tomosynthesis

Hip Prosthesis Imaging Clinical Trial

— PLIDET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02874196
• Other study ID #: 2011-A00677-34
• Status: Completed
• Phase: N/A
• First received: August 17, 2016
• Last updated: August 17, 2016
• Start date: July 2012
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hip Prosthesis Imaging

Intervention

Procedure:
• Standard arthrography

• Dual energy arthrography

• Arthro-tomosynthesis

• Arthro-tomography

• Surgery on painful prosthesis
Possibly performed during 6 months from arthrography

Locations

Country	Name	City	State
France	CHU de Nancy	Nancy
France	SINCAL	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of prosthesis loosening detected with 3 radiographic techniques (dual-energy arthrography, arthro-tomosynthesis and single-energy tomography) and surgery	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	No
Secondary	Comparison between density differential between 2 acquisitions and grey level on subtraction		day 0	No