## Protocol Section
### Identification Module
**NCT ID:** NCT01349179

**Acronym:** ETOSA

**Brief Title:** Scan Hip Evaluation

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

#### Organization Study ID Info
**ID:** CHU-089
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Clermont-Ferrand
### Status Module
#### Completion Date
**Date:** 2011-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-07-08

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-07-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-09

**Type:** ACTUAL

#### Start Date
**Date:** 2010-12

**Status Verified Date:** 2014-07

#### Study First Post Date
**Date:** 2011-05-06
**Type:** ESTIMATED
**Study First Submit Date:** 2011-02-22
**Study First Submit QC Date:** 2011-05-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Clermont-Ferrand

#### Responsible Party

**Type:** SPONSOR

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hip Arthroplasty

**Keywords:**

- Hip

- Arthroplasty

- Metal on metal

- operated on 2002

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 54

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

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

**Name:** Metal on metal hip arthroplasty operated on 2002

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Realization of a scan nine years after the surgery of total hip arthroplasty

**Time Frame:** after nine years

#### Secondary Outcomes

**Measure:** Clinical results preoperative Postel Merle d'Aubigné, Harris score preoperative and SF12 scores preoperative (before the hip surgery)

**Time Frame:** after nine years

**Measure:** Cooperating X-ray assessments and scan

**Time Frame:** after nine years

**Measure:** Realization of a X-ray and a scan then comparison of the results obtained

**Time Frame:** after nine years

**Measure:** Concentrations of cobalt: chrome and nickel in blood

**Time Frame:** after nine years

**Measure:** Rate of survival of the prosthesis

**Time Frame:** after nine years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* Expectant mothers

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Clermont-Ferrand

**Country:** France

**Facility:** CHU Clermont-Ferrand

**Zip:** 63003

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital, Clermont-Ferrand

**Name:** Stéphane DESCAMPS, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
