A Clinical Investigation of Recovery Following Hip Resurfacing or Total Hip Arthroplasty
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ClinicalTrials.gov Identifier: NCT00585988 |
Recruitment Status
:
Withdrawn
First Posted
: January 4, 2008
Last Update Posted
: June 21, 2017
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Sponsor:
Biomet Orthopedics, LLC
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )
Tracking Information | |||
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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 |
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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Withdrawn | ||
Actual Enrollment ICMJE |
0 | ||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |