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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758355
First Posted: September 25, 2008
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biomet France SARL
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose
Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing.

Condition
Total Hip Resurfacing

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Zimmer Biomet:

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

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

Enrollment: 150
Study Start Date: March 2008
Study Completion Date: June 2016
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

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 Submitted: September 23, 2008
First Posted: September 25, 2008
Last Update Posted: February 23, 2017
Last Verified: January 2017