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

This study is currently recruiting participants.

Verified by Biomet, Inc., December 2009

First Received: September 23, 2008 Last Updated: December 11, 2009 History of Changes

Sponsor:	Biomet, Inc.
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00758355

Purpose

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

Condition
Total Hip Resurfacing Arthroplasty, Replacement, Hip

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Prospective, Multicentre Study Evaluating the Clinical Performance of the ReCap/Magnum in Total Hip Replacement and Resurfacing

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:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated 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

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

Contacts

Contact: Gregoire Edorh

+ 33 (0)4 75 75 91 19

Locations

France
CHU Pellegrin Tripode	Recruiting
Bordeaux, France
Contact: Dominique CHAUVEAUX, MD 05 56 79 56 79
Principal Investigator: Dominique Chauveaux, Ph - MD
Polyclinique de Hénin Beaumont	Recruiting
Henin-beaumont, France
Contact: Sylvain GUERIOT, MD 03.21.13.31.90
Sub-Investigator: Sylvain GUERIOT, MD
Principal Investigator: Philippe STAHL, MD
CHU Hôpital Sud	Recruiting
Grenoble, France
Contact: Dominique Saragaglia, Ph - MD
Principal Investigator: Dominique Saragaglia, Ph-MD
Polyclinique de Riaumont	Recruiting
Lievin, France
Contact: Didier Ghestem, MD
Principal Investigator: Didier Ghestem, MD
Clinique Saint Andre	Recruiting
Reims, France
Contact: Marc Ameil, MD
Sub-Investigator: Marc Ameil, MD

Sponsors and Collaborators

Biomet, Inc.

More Information

No publications provided

Responsible Party:	Biomet France ( Gregoire Edorh, Clinical Manager )
Study ID Numbers:	BMET FR 04
Study First Received:	September 23, 2008
Last Updated:	December 11, 2009
ClinicalTrials.gov Identifier:	NCT00758355 History of Changes
Health Authority:	France: French Data Protection Authority

ClinicalTrials.gov processed this record on February 08, 2010