Hip Prosthesis ImagingPLIDETNCT02874196
Prosthesis Loosening Imaging With Dual Energy and Tomosynthesis
A study testing Standard arthrography, Dual energy arthrography and Arthro-tomosynthesis in people with Hip Prosthesis Imaging, run by Central Hospital, Nancy, France at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Prosthesis Imaging
- What is being tested?
- Standard arthrography, Dual energy arthrography and Arthro-tomosynthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any contraindication to arthrography or injection of contrast agent
- Pregnant or possibly pregnant women
- Patient under guardianship
- Refusal or impossibility of informed consent
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Study of Diagnostic Performances of Dual Energy Imaging With Flat Detectors and Tomosynthesis in Identification of Loosening of Painful Hip Prosthesis
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
Read the 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.
- Conditions
- Hip Prosthesis Imaging
- Being tested
- Standard arthrography, Dual energy arthrography, Arthro-tomosynthesis, Arthro-tomography, Surgery on painful prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard arthrographyProcedure or surgery
Dual energy arthrographyProcedure or surgery
Arthro-tomosynthesisProcedure or surgery
Arthro-tomographyProcedure or surgery
Surgery on painful prosthesisProcedure or surgery
Possibly performed during 6 months from arthrography
| Study group | Role | What they receive |
|---|---|---|
| Patients with painful prosthesis | Experimental | Not described Receives: Procedure: Standard arthrography; Procedure: Dual energy arthrography; Procedure: Arthro-tomosynthesis; Procedure: Arthro-tomography; Procedure: Surgery on painful prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from day 0 up to 6 months
Secondary outcomes (1)
Comparison between density differential between 2 acquisitions and grey level on subtraction
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startJul 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Prosthesis ImagingStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Blum, Principal investigator, Service d'Imagerie Guilloz - CHU Nancy - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874196
- Sponsor's protocol ID
- 2011-A00677-34
- Acronym
- PLIDET
- Status last verified
- Aug 2016
- First submitted
- 17 Aug 2016
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Diagnostic Performances of Dual Energy Imaging With Flat Detectors and Tomosynthesis in Identification of Loosening of Painful Hip Prosthesis
- ClinicalTrials.gov ID
- NCT02874196
- Acronym / sponsor ID
- PLIDET / 2011-A00677-34
- Conditions
- Hip Prosthesis Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with painful prosthesis | Experimental | Procedure: Standard arthrography, Procedure: Dual energy arthrography, Procedure: Arthro-tomosynthesis, Procedure: Arthro-tomography, Procedure: Surgery on painful prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Any contraindication to arthrography or injection of contrast agent
- Pregnant or possibly pregnant women
- Patient under guardianship
- Refusal or impossibility of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard arthrography | Procedure or surgery | Patients with painful prosthesis |
| Dual energy arthrography | Procedure or surgery | Patients with painful prosthesis |
| Arthro-tomosynthesis | Procedure or surgery | Patients with painful prosthesis |
| Arthro-tomography | Procedure or surgery | Patients with painful prosthesis |
| Surgery on painful prosthesisPossibly performed during 6 months from arthrography | Procedure or surgery | Patients with painful prosthesis |
Primary outcome
Presence or absence of prosthesis loosening detected with 3 radiographic techniques (dual-energy arthrography, arthro-tomosynthesis and single-energy tomography) and surgery
Time frame: 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.
1 secondary outcome
Comparison between density differential between 2 acquisitions and grey level on subtraction
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Blum principal investigator
Service d'Imagerie Guilloz - CHU Nancy - France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard arthrography, Dual energy arthrography and Arthro-tomosynthesis in people with Hip Prosthesis Imaging, run by Central Hospital, Nancy, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of prosthesis loosening detected with 3 radiographic techniques (dual-energy arthrography, arthro-tomosynthesis and single-energy tomography) and surgery (time frame: from day 0 up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.