Skip to content

Scan Hip Evaluation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01349179
Acronym
ETOSA
Enrollment
54
Registered
2011-05-06
Start date
2010-12-31
Completion date
2011-09-30
Last updated
2014-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthroplasty

Keywords

Hip, Arthroplasty, Metal on metal, operated on 2002

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.

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.

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.

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Expectant mothers

Design outcomes

Primary

MeasureTime frame
Realization of a scan nine years after the surgery of total hip arthroplastyafter nine years

Secondary

MeasureTime frame
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 scanafter nine years
Realization of a X-ray and a scan then comparison of the results obtainedafter nine years
Concentrations of cobalt: chrome and nickel in bloodafter nine years
Rate of survival of the prosthesisafter nine years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026