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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: January 7, 2013
Last verified: January 2013
History of Changes
  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:
  • 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 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

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
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: January 7, 2013
Health Authority: France: French Data Protection Authority

ClinicalTrials.gov processed this record on May 19, 2013