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

Tracking Information
First Submitted Date ICMJE	December 21, 2007
First Posted Date ICMJE	January 4, 2008
Last Update Posted Date	June 21, 2017
Study 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 ]
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 Applicable
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (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 Arms	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Recruitment Status ICMJE	Withdrawn
Actual Enrollment ICMJE; (submitted: February 29, 2012)	0
Original Estimated Enrollment ICMJE; (submitted: December 21, 2007)	150
Estimated Study 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
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	United States
Administrative Information
NCT Number ICMJE	NCT00585988
Other Study ID Numbers ICMJE	292-U-010
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Zimmer Biomet ( Biomet Orthopedics, LLC )
Study Sponsor ICMJE	Biomet Orthopedics, LLC
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Zimmer Biomet
Verification Date	June 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP