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

This study is ongoing, but not recruiting participants.

First Received on September 23, 2008. Last Updated on December 5, 2011 History of Changes

Sponsor:	Biomet, Inc.
Collaborator:	Biomet France SARL
Information provided by (Responsible Party):	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00758355

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:

MedlinePlus related topics: Hip Replacement

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Postel-Merle d'Aubigné (PMA), Harris Hip Score [ Time Frame: 1yr and 2yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Enrollment:	150
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Consecutive series of patients received Total Hip Resurfacing with ReCap/Magnum
2 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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758355

Locations

France
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

Biomet, Inc.

Biomet France SARL

More Information

No publications provided

Responsible Party:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00758355 History of Changes
Other Study ID Numbers:	BMET FR 04
Study First Received:	September 23, 2008
Last Updated:	December 5, 2011
Health Authority:	France: French Data Protection Authority

ClinicalTrials.gov processed this record on February 09, 2012