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Completed

NCT Number: NCT01349179

Scan Hip Evaluation

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".

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Key information

Conditions

Hip Arthroplasty

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Expectant mothers

Treatment and study plan

Metal on metal hip arthroplasty operated on 2002

Device

The purpose of the study is to evaluate the presence of geodes acetabular and femoral with scan examination.

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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: ETOSA

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 6, 2011
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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