Completed

Prospective, Multicentric, Observational Cohort Study for the Evaluation of Implant Survival in Patients With a Metal-on-Metal Pinnacle(R) Ultamet(TM) Device in Conventional Total Hip Joint Replacement.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Device Data

Collected from today forward - Prospective
Device
Who is being recruted

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2009
See protocol details

Summary

Principal SponsorDePuy International
Last updated: September 26, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2009

Actual date on which the first participant was enrolled.

The objective is to evaluate the implant survival rate for patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease and true femoral cervical fracture.

NCT01684631
Principal SponsorDePuy International
Last updated: September 26, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

107 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
Patients susceptible to receive a PINNACLE ULTAMETTM implant as per routine practice
9 exclusion criteria prevent from participating
Exposure to cobalt and chromium that could influence serum metal ions levels
Patient not implanted with a Pinnacle(R) ULTAMET(TM)
Patient refusal to participate to the data collection
Patient residing outside France
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Clinique Herbert

Aix-les-Bains, FranceOpen Clinique Herbert in Google Maps

Clinique Bonnefon

Alès, France

Centre Hospitalier Georges Renon

Niort, France

Clinique Saint Hilaire

Rouen, France
Completed6 Study Centers