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A Clinical Investigation of Recovery Following Hip Resurfacing or Total Hip Arthroplasty
This study has been withdrawn prior to enrollment.
Sponsor:
Biomet Orthopedics, LLC
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00585988
First received: December 21, 2007
Last updated: June 19, 2017
Last verified: June 2017
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | December 21, 2007 | ||
| Last Updated Date | June 19, 2017 | ||
| 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 Provided | ||
| 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 | ||
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* 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 | ||
| 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:
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 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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