CClinicalTrials.gg
CompletedNCT01349179ETOSAUpdated Jul 8, 2014

Scan Hip Evaluation

An interventional study of Metal on metal hip arthroplasty operated on 2002 in Hip Arthroplasty, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2014-07-08.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Non-randomized
Sex
All
01

Study 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".

Read the 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.

02

Conditions studied

  • Hip Arthroplasty

Keywords

  • Hip
  • Arthroplasty
  • Metal on metal
  • operated on 2002
03

In context

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Expectant mothers
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (actual)

Interventions

  • DeviceMetal 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.

06

What researchers measure

Primary outcomes

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

    Time frame: after nine years

Secondary outcomes

  1. Clinical results preoperative Postel Merle d'Aubigné, Harris score preoperative and SF12 scores preoperative (before the hip surgery)

    Time frame: after nine years

  2. Cooperating X-ray assessments and scan

    Time frame: after nine years

  3. Realization of a X-ray and a scan then comparison of the results obtained

    Time frame: after nine years

  4. Concentrations of cobalt: chrome and nickel in blood

    Time frame: after nine years

  5. Rate of survival of the prosthesis

    Time frame: after nine years

07

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01349179
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
May 6, 2011
Start date
Dec 2010
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Jul 8, 2014

Study contacts

Stéphane DESCAMPS, MD
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion