Incidence of Dual Mobility Polyethylene Wear in Total Hip Prosthesis. Randomised Study Versus Fixed Insert by Radiostereometric Analysis.
NCT ID: NCT02525809
Last Updated: 2020-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2010-03-31
2015-08-31
Brief Summary
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The evaluation process used in this study will be the extent of penetration of the metal femoral head in the cup and micro mobility metal back by radiostereometric analysis (RSA) whose precision provides early results (2 3 years), long before wear and migration are measurable by conventional radiological means. The main objective will be to compare, 2 years after the intervention, the penetration of the metal femoral head in 3 types of inserts: two dual mobility inserts, one at tripod attachment (Novae E®), the other press fit pure (Sunfit®), and a fixed insert (Quartz®).
This is a randomized controlled trial. 105 patients will be enrolled (35 in each group). Patients will be included in each of the two participating centers (Amiens, Caen). The analysis will be made in RSA D7 + 2, 6 months 1, 12 months 1 24 months 1. An assessment will be made to 3 years if the analysis requires it to 2 years.
Analysis of pictures will be centralized in Caen and performed with specific software after transferring images via a secure network.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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mobility insert with tripod attachment (Novae E®)
mobility insert with tripod attachment (Novae E®)
Novae E®
mobility insert with press fit pure (Sunfit®)
mobility insert with press fit pure (Sunfit®)
Sunfit®
fixed insert (Quartz®).
fixed insert (Quartz®).
Quartz®
Interventions
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Novae E®
Sunfit®
Quartz®
Eligibility Criteria
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Inclusion Criteria
* with a primary or secondary osteoarthritis or osteonecrosis
* having a functional disorder requiring the installation of a total hip prosthesis of primary
Exclusion Criteria
* protected adults
* resumption of PTH
* cephalic prosthesis recovery or intermediate
* resumption of cupules
* primary or secondary malignant tumor of the hip
60 Years
75 Years
ALL
No
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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Other Identifiers
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08-114
Identifier Type: -
Identifier Source: org_study_id
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