Scan Hip Evaluation (ETOSA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01349179
First received: February 22, 2011
Last updated: October 17, 2011
Last verified: October 2011
  Purpose

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".


Condition Intervention
Hip Arthroplasty
Device: Metal on metal hip arthroplasty operated on 2002

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Scan Evaluation at 9 Years of the Bone Acetabular Supporting Cups Without Cement (Couple Metal/Metal in Diameter 28 mm)

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Realization of a scan nine years after the surgery of total hip arthroplasty [ Time Frame: after nine years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical results preoperative Postel Merle d'Aubigné, Harris score preoperative and SF12 scores preoperative (before the hip surgery) [ Time Frame: after nine years ] [ Designated as safety issue: Yes ]
  • Cooperating X-ray assessments and scan [ Time Frame: after nine years ] [ Designated as safety issue: Yes ]
  • Realization of a X-ray and a scan then comparison of the results obtained [ Time Frame: after nine years ] [ Designated as safety issue: Yes ]
  • Concentrations of cobalt: chrome and nickel in blood [ Time Frame: after nine years ] [ Designated as safety issue: Yes ]
  • Rate of survival of the prosthesis [ Time Frame: after nine years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Metal on metal hip arthroplasty operated on 2002
    The purpose of the study is to evaluate the presence of geodes acetabular and femoral with scan examination.
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Expectant mothers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349179

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Stéphane DESCAMPS, MD University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01349179     History of Changes
Other Study ID Numbers: CHU60089
Study First Received: February 22, 2011
Last Updated: October 17, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Hip
Arthroplasty
Metal on metal
operated on 2002

ClinicalTrials.gov processed this record on April 14, 2014