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Clinical Trials/NCT01349179
NCT01349179
Completed
N/A

Scan Evaluation at 9 Years of the Bone Acetabular Supporting Cups Without Cement (Couple Metal/Metal in Diameter 28 mm)

University Hospital, Clermont-Ferrand1 site in 1 country54 target enrollmentDecember 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hip Arthroplasty
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
54
Locations
1
Primary Endpoint
Realization of a scan nine years after the surgery of total hip arthroplasty
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The couple of friction metal-polyethylene is regarded as the couple of reference in spite of the osteolysis induced by the wear of the polyethylene which remains the independent factor of long-term failure. This is all the more true as the patients are young, thus justifying the recourse to alternate couples of friction. The Metasul® couple was introduced on the French market under its current form in 1995 (year of its marking EC). The use of a couple of friction metal-metal (MM) is justified because it would be likely to improve longevity of the total arthroplasties of the active subjects by the reduction in osteolysis related to the wear of polyethylene. Various studies highlight evolutions different according to the types of fixing acetabular; favourable results of the not cemented cups contrasting with unsealings and the evolutionary edgings of the Metasul® cups cemented of or the cups "of cemented Weber type".

Detailed Description

Radiographies standards allow the follow-up of the total prostheses of hip but those underestimate the incidence and the extension of osteolyses perished-acetabular which are generally asymptomatic initially. The lack of international consensus on the definition of the parameters of interpretation of the radiological follow-up of the PTH makes difficult the comparison of the various results. The purpose of the study is to evaluate the presence of geodes acetabular and femoral with scan examination.

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
September 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Metal on metal hip arthroplasty operated on 2002
  • Age older than 40 years

Exclusion Criteria

  • Expectant mothers

Outcomes

Primary Outcomes

Realization of a scan nine years after the surgery of total hip arthroplasty

Time Frame: after nine years

Secondary Outcomes

  • Clinical results preoperative Postel Merle d'Aubigné, Harris score preoperative and SF12 scores preoperative (before the hip surgery)(after nine years)
  • Cooperating X-ray assessments and scan(after nine years)
  • Realization of a X-ray and a scan then comparison of the results obtained(after nine years)
  • Rate of survival of the prosthesis(after nine years)
  • Concentrations of cobalt: chrome and nickel in blood(after nine years)

Study Sites (1)

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