CompletedNot Applicable

Prosthesis Loosening Imaging With Dual Energy and Tomosynthesis

France66 participantsStarted 2012-07

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

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

Timeframe: from day 0 up to 6 months

Trial details

NCT IDNCT02874196

SponsorCentral Hospital, Nancy, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09

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