Scan Hip Evaluation (ETOSA)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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".
| Condition | Intervention |
|---|---|
|
Hip Arthroplasty |
Device: Metal on metal hip arthroplasty operated on 2002 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Scan Evaluation at 9 Years of the Bone Acetabular Supporting Cups Without Cement (Couple Metal/Metal in Diameter 28 mm) |
- Realization of a scan nine years after the surgery of total hip arthroplasty [ Time Frame: after nine years ] [ Designated as safety issue: Yes ]
- Clinical results preoperative Postel Merle d'Aubigné, Harris score preoperative and SF12 scores preoperative (before the hip surgery) [ Time Frame: after nine years ] [ Designated as safety issue: Yes ]
- Cooperating X-ray assessments and scan [ Time Frame: after nine years ] [ Designated as safety issue: Yes ]
- Realization of a X-ray and a scan then comparison of the results obtained [ Time Frame: after nine years ] [ Designated as safety issue: Yes ]
- Concentrations of cobalt: chrome and nickel in blood [ Time Frame: after nine years ] [ Designated as safety issue: Yes ]
- Rate of survival of the prosthesis [ Time Frame: after nine years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
-
Device: Metal on metal hip arthroplasty operated on 2002
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Metal on metal hip arthroplasty operated on 2002
- Age older than 40 years
Exclusion Criteria:
- Expectant mothers
Contacts and Locations| France | |
| CHU Clermont-Ferrand | |
| Clermont-Ferrand, France, 63003 | |
| Principal Investigator: | Stéphane DESCAMPS, MD | University Hospital, Clermont-Ferrand |
More Information
No publications provided
| Responsible Party: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT01349179 History of Changes |
| Other Study ID Numbers: | CHU60089 |
| Study First Received: | February 22, 2011 |
| Last Updated: | October 17, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
Hip Arthroplasty Metal on metal operated on 2002 |
ClinicalTrials.gov processed this record on May 19, 2013