A Clinical Investigation of Recovery Following Hip Resurfacing or Total Hip Arthroplasty

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

Biomet, Inc. ( Biomet Orthopedics, LLC )

ClinicalTrials.gov Identifier:

NCT00585988

First received: December 21, 2007

Last updated: June 27, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 21, 2007
Last Updated Date	June 27, 2012
Start Date ^ICMJE	June 2007
Estimated Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 21, 2007)	Functional Tests [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00585988 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Investigation of Recovery Following Hip Resurfacing or Total Hip Arthroplasty
Official Title ^ICMJE	Functional Recovery Following Hip Resurfacing or Total Hip Arthroplasty in Patients Matched By Age, Gender, and Activity Level
Brief Summary	The primary purpose of this study is to compare early functional outcomes in patients undergoing hip resurfacing and total hip arthroplasty with the M2a-Magnum™ using more objective measures of function.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Osteoarthritis Rheumatoid Arthritis Arthritis Traumatic Arthritis
Intervention ^ICMJE	Device: Hip Resurfacing System This arm will utilize a hip resurfacing system. Device: M2a-Magnum™ Large Metal Articulation This arm will utilize the M2a-Magnum™ implant system.
Study Arm (s)	1 Intervention: Device: Hip Resurfacing System 2 Intervention: Device: M2a-Magnum™ Large Metal Articulation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	0
Estimated Completion Date	September 2010
Estimated Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients requiring hip arthroplasty Exclusion Criteria: Patients with sensory, neurological, or general health conditions that alter perception of their limb in space Patients with vestibular disorders
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	Not Provided
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT00585988
Other Study ID Numbers ^ICMJE	292-U-010
Has Data Monitoring Committee	No
Responsible Party	Biomet, Inc. ( Biomet Orthopedics, LLC )
Study Sponsor ^ICMJE	Biomet Orthopedics, LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biomet, Inc.
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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