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Prosthesis Loosening Imaging With Dual Energy and Tomosynthesis (PLIDET)

C

Central Hospital, Nancy, France

Status

Completed

Conditions

Hip Prosthesis Imaging

Treatments

Procedure: Surgery on painful prosthesis
Procedure: Arthro-tomosynthesis
Procedure: Dual energy arthrography
Procedure: Standard arthrography
Procedure: Arthro-tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT02874196
2011-A00677-34

Details and patient eligibility

About

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

Full 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.

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

66 participants in 1 patient group

Patients with painful prosthesis
Experimental group
Treatment:
Procedure: Arthro-tomography
Procedure: Surgery on painful prosthesis
Procedure: Arthro-tomosynthesis
Procedure: Standard arthrography
Procedure: Dual energy arthrography

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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