Data Collection on ReCap/Magnum in Total Hip Replacement and Resurfacing

February 21, 2017 updated by: Zimmer Biomet

A Prospective, Multicentre Study Evaluating the Clinical Performance of the ReCap/Magnum in Total Hip Replacement and Resurfacing

Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing.

Study Overview

Status

Completed

Detailed Description

This observational study intends to collect efficacy and safety data on ReCap/Magnum in Total Hip Replacement and Resurfacing.

Study Type

Observational

Enrollment (Actual)

150

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

      • Amiens, France, 80000
        • CHU Amiens
      • Bordeaux, France
        • CHU Pellegrin Tripode
      • Grenoble, France
        • CHU Hopital Sud
      • Henin-beaumont, France
        • Polyclinique de Hénin Beaumont
      • Lievin, France
        • Polyclinique de Riaumont
      • Reims, France
        • Clinique Saint Andre

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

Non-Probability Sample

Study Population

Consecutive series of patients received Total Hip Replacement or Resurfacing with ReCap/Magnum for Their Respective Indications for Use/Intended Uses

Description

Inclusion Criteria:

Consecutive series of patients received Total Hip Replacement or Resurfacing with ReCap/Magnum for Its Respective Indications for Use/Intended Uses

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
M2A magnum
Consecutive series of patients received Total Hip Resurfacing with ReCap/Magnum
Recap Magnum
Consecutive series of patients received Total Hip Replacement with ReCap/Magnum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postel-Merle d'Aubigné (PMA), Harris Hip Score
Time Frame: 1yr and 2yr
1yr and 2yr

Secondary Outcome Measures

Outcome Measure
Time Frame
Complication
Time Frame: Any time
Any time
Survival
Time Frame: 1yr and 2yr
1yr and 2yr

Collaborators and Investigators

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

Sponsor

Collaborators

Investigators

  • Principal Investigator: Dominique Saragaglia, Pr, Hopital Sud - Echirolles

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

March 1, 2008

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 23, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • BMETEU.CR.FR04

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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