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

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ClinicalTrials.gov Identifier: NCT00758355
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing.

Condition or disease
Total Hip Resurfacing

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

Study Design

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the ReCap/Magnum in Total Hip Replacement and Resurfacing
Study Start Date : March 2008
Primary Completion Date : December 2013
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Postel-Merle d'Aubigné (PMA), Harris Hip Score [ Time Frame: 1yr and 2yr ]

Secondary Outcome Measures :
  1. Complication [ Time Frame: Any time ]
  2. Survival [ Time Frame: 1yr and 2yr ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758355


Locations
France
CHU Amiens
Amiens, France, 80000
CHU Pellegrin Tripode
Bordeaux, France
CHU Hôpital Sud
Grenoble, France
Polyclinique de Hénin Beaumont
Henin-beaumont, France
Polyclinique de Riaumont
Lievin, France
Clinique Saint Andre
Reims, France
Sponsors and Collaborators
Zimmer Biomet
Biomet France SARL
Investigators
Principal Investigator: Dominique Saragaglia, Pr Hopital Sud - Echirolles
More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00758355     History of Changes
Other Study ID Numbers: BMETEU.CR.FR04
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: January 2017