Scan Hip Evaluation

Not Applicable

Completed

• Conditions: Hip Arthroplasty

• Registration Number: NCT01349179
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-05-05
• Study First Posted: 2011-05-06
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-04
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

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

Exclusion Criteria

• Expectant mothers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France