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Clinical Trials/NCT02525809
NCT02525809
Completed
Not Applicable

Incidence of Dual Mobility Polyethylene Wear in Total Hip Prosthesis. Randomised Study Versus Fixed Insert by Radiostereometric Analysis.

University Hospital, Caen0 sites82 target enrollmentMarch 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Hip Replacement
Sponsor
University Hospital, Caen
Enrollment
82
Primary Endpoint
Measuring the penetration of the femoral head in the polyethylene inserts by radiostereometric analysis (RSA)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, observation showed that the dislocation is not a rare complication (2-4%) and the lifetime of the implants is limited due to aseptic loosening.

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
August 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients older men or women 60-75 years
  • with a primary or secondary osteoarthritis or osteonecrosis
  • having a functional disorder requiring the installation of a total hip prosthesis of primary

Exclusion Criteria

  • patients aged 76 years or more
  • protected adults
  • resumption of PTH
  • cephalic prosthesis recovery or intermediate
  • resumption of cupules
  • primary or secondary malignant tumor of the hip

Outcomes

Primary Outcomes

Measuring the penetration of the femoral head in the polyethylene inserts by radiostereometric analysis (RSA)

Time Frame: change over baseline and 3 years

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