Scan Hip Evaluation

Hip Arthroplasty Clinical Trial

— ETOSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349179
• Other study ID #: CHU-089
• Status: Completed
• Phase: N/A
• First received: February 22, 2011
• Last updated: July 4, 2014
• Start date: December 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Metal on metal hip arthroplasty operated on 2002

• Age older than 40 years

Exclusion Criteria:

• Expectant mothers

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Arthroplasty

Intervention

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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Realization of a scan nine years after the surgery of total hip arthroplasty		after nine years	Yes
Secondary	Clinical results preoperative Postel Merle d'Aubigné, Harris score preoperative and SF12 scores preoperative (before the hip surgery)		after nine years	Yes
Secondary	Cooperating X-ray assessments and scan		after nine years	Yes
Secondary	Realization of a X-ray and a scan then comparison of the results obtained		after nine years	Yes
Secondary	Concentrations of cobalt: chrome and nickel in blood		after nine years	Yes
Secondary	Rate of survival of the prosthesis		after nine years	Yes