- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00758355
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
Conditions
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
-
-
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Amiens, France, 80000
- CHU Amiens
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Bordeaux, France
- CHU Pellegrin Tripode
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Grenoble, France
- CHU Hopital Sud
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Henin-beaumont, France
- Polyclinique de Hénin Beaumont
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Lievin, France
- Polyclinique de Riaumont
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Reims, France
- Clinique Saint Andre
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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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