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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Biomet France SARL
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00758355
First received: September 23, 2008
Last updated: February 10, 2014
Last verified: February 2014
  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 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:
  • Complication [ Time Frame: Any time ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: 1yr and 2yr ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: March 2008
Estimated Study Completion Date: February 2018
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Biomet, Inc.
Biomet France SARL
Investigators
Principal Investigator: Dominique Saragaglia, Pr Hopital Sud - Echirolles
  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: February 10, 2014
Health Authority: France: French Data Protection Authority

ClinicalTrials.gov processed this record on August 28, 2014