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

This study has been completed.
Sponsor:
Collaborator:
Biomet France SARL
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00758355
First received: September 23, 2008
Last updated: July 18, 2016
Last verified: July 2016

September 23, 2008
July 18, 2016
March 2008
December 2013   (final data collection date for primary outcome measure)
Postel-Merle d'Aubigné (PMA), Harris Hip Score [ Time Frame: 1yr and 2yr ] [ Designated as safety issue: No ]
Postel-Merle d'Aubigné (PMA), Harris Hip Score [ Time Frame: 5 yr ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00758355 on ClinicalTrials.gov Archive Site
  • Complication [ Time Frame: Any time ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: 1yr and 2yr ] [ Designated as safety issue: Yes ]
Complication [ Time Frame: Any time ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Data Collection on ReCap/Magnum in Total Hip Replacement and Resurfacing
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.
This observational study intends to collect efficacy and safety data on ReCap/Magnum in Total Hip Replacement and Resurfacing.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Consecutive series of patients received Total Hip Replacement or Resurfacing with ReCap/Magnum for Their Respective Indications for Use/Intended Uses
Total Hip Resurfacing
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
June 2016
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00758355
BMETEU.CR.FR04
No
Not Provided
Not Provided
Biomet, Inc.
Biomet, Inc.
Biomet France SARL
Principal Investigator: Dominique Saragaglia, Pr Hopital Sud - Echirolles
Biomet, Inc.
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP