An interventional study of Standard arthrography and Dual energy arthrography in Hip Prosthesis Imaging, sponsored by Central Hospital, Nancy, France. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-22.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic
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:
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.
Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Standard arthrography · Procedure: Dual energy arthrography · Procedure: Arthro-tomosynthesis · Procedure: Arthro-tomography · Procedure: Surgery on painful prosthesis
Possibly performed during 6 months from arthrography
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.
Time frame: from day 0 up to 6 months
Comparison between density differential between 2 acquisitions and grey level on subtraction
Time frame: day 0
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France