Scan Hip Evaluation

NCT01349179 | Completed

• 1 other identifier: CHU-089
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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".

Conditions

Hip Arthroplasty

Keywords

Hip; Arthroplasty; Metal on metal; operated on 2002

Outcome Measures

Primary Outcomes (1)

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

  after nine years

Secondary Outcomes (5)

• 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

• Concentrations of cobalt: chrome and nickel in blood

  after nine years

• Rate of survival of the prosthesis

  after nine years

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Expectant mothers

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

• Stéphane DESCAMPS, MD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: May 6, 2011
• Study Start: December 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

FR (1)