Evaluation of Implant Survival in Patients With a Pinnacle Ultamet Device in Conventional Total Hip Joint Replacement

September 23, 2016 updated by: DePuy International

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-les-Bains, France, 73100
        • Clinique HERBERT
      • Ales, France, 30104
        • Clinique Bonnefon
      • Niort, France, 79021
        • Centre Hospitalier Georges Renon
      • Rouen, France, 76000
        • Clinique Saint Hilaire
      • Royan, France, 17200
        • Clinique Pasteur
      • Saint Etienne, France, 42013
        • Clinique Mutualiste Saint Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients susceptible to receive a PINNACLE® ULTAMET™ implant

Description

Inclusion Criteria:

  • Patients susceptible to receive a PINNACLE® ULTAMET™ implant as per routine practice

Exclusion Criteria:

  • Patient refusal to participate to the data collection
  • Pregnant woman
  • Patients age is less than 18 years old
  • The planned intervention is a revision of a previous intervention on the studied hip joint
  • Previous metal implant, except for pure titanium or titanium alloys
  • Exposure to cobalt and chromium that could influence serum metal ions levels
  • Planned bilateral intervention
  • Patient residing outside France
  • Patient not implanted with a Pinnacle(R) ULTAMET(TM)

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hip arthroplasty
Patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease or true femoral cervical fracture.
Device: Total Hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survival Rate
Time Frame: up to 5 years
Implant Survival Rate as the duration of PINNACLE® ULTAMET™ implantation for the follow-up duration, free of revision surgery, whatever the cause.
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris Hip Score
Time Frame: pre-operative, 1, 2, 3, 5 years
Measure of hip function using the Harris Hip Score
pre-operative, 1, 2, 3, 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cobalt and Chromium serum concentration
Time Frame: 3 to 6 Months, 1, 2, 3, 5 years
Descriptive analysis of patient serum concentration of Cobalt and Chromium
3 to 6 Months, 1, 2, 3, 5 years
Adverse Event Frequency
Time Frame: Per-operative, 3 to 6 Months, 1, 2, 3, 5 years
Descriptive Analysis of Adverse Event Frequency for the duration of the study.
Per-operative, 3 to 6 Months, 1, 2, 3, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy International

Investigators

  • Principal Investigator: Jean-Marie Toupin, MD, Clinique Saint Hilaire Rouen, France 76000

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

September 12, 2012

First Posted (ESTIMATE)

September 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 26, 2016

Last Update Submitted That Met QC Criteria

September 23, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27062008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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