Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem (MOM)
This study has been terminated.
(Components were recalled by Depuy)
Sponsor:
Capital District Health Authority, Canada
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01422564
First received: August 12, 2011
Last updated: March 6, 2012
Last verified: May 2007
| Tracking Information | |||||
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| First Received Date ICMJE | August 12, 2011 | ||||
| Last Updated Date | March 6, 2012 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Revision Rate [ Time Frame: 4 years ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01422564 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem | ||||
| Official Title ICMJE | A Randomized Multicentre Clinical Trial Comparing The Metal on Metal Hip System Versus The Metal on Highly Crossed Linked Polyethylene System | ||||
| Brief Summary | This trial will evaluate the 36mm or greater metal head on metal hip system and compare it to the 32mm or 28mm metal head on polyethylene (liner) hip system in patients receiving a primary cementless total hip replacement. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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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 | Terminated | ||||
| Enrollment ICMJE | 41 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01422564 | ||||
| Other Study ID Numbers ICMJE | RL 006, Contract | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Capital District Health Authority, Canada | ||||
| Study Sponsor ICMJE | Capital District Health Authority, Canada | ||||
| Collaborators ICMJE | University Health Network, Toronto | ||||
| Investigators ICMJE |
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| Information Provided By | Capital District Health Authority, Canada | ||||
| Verification Date | May 2007 | ||||
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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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