Prosthesis Loosening Imaging With Dual Energy and Tomosynthesis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02874196

Acronym

PLIDET

Enrollment

Registered

2016-08-22

Start date

2012-07-31

Completion date

2015-09-30

Last updated

2016-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Prosthesis Imaging

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.

Interventions

PROCEDUREStandard arthrography

PROCEDUREDual energy arthrography

PROCEDUREArthro-tomosynthesis

PROCEDUREArthro-tomography

PROCEDURESurgery on painful prosthesis

Possibly performed during 6 months from arthrography

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Comparison between density differential between 2 acquisitions and grey level on subtraction	day 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026