Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

[Trial of device that is not approved or cleared by the U.S. FDA]

This trial has been identified as being associated with a clinical device that has not been approved or cleared by the US Food and Drug Administration. Under the terms of US Public Law 110-85, Title VIII, Section 801, the details of this study are not available to the public.
Sponsor:
Information provided by:
[Redacted]
ClinicalTrials.gov Identifier:
NCT00754520
First received: September 16, 2008
Last updated: October 15, 2014
Last verified: NA

September 16, 2008
October 15, 2014
May 2009
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Composite Clinical Success (CCS) Rate as defined in the protocol [ Time Frame: 6 weeks, 6 months, annually up to 10 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00754520 on ClinicalTrials.gov Archive Site
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  • Oxford Hip Score [ Time Frame: 6 weeks, 6 months, annually up to 10 years ] [ Designated as safety issue: No ]
  • Womac Score [ Time Frame: 6 weeks, 6 months, annually up to 10 years ] [ Designated as safety issue: No ]
  • Metal Ion concentrations in blood and urine [ Time Frame: 6 weeks, 6 months, annually up to 10 years ] [ Designated as safety issue: Yes ]
  • Measurement of cellular markers in blood [ Time Frame: 6 weeks, 6 months, annually up to 10 years ] [ Designated as safety issue: Yes ]
  • Complications [ Time Frame: Any Time ] [ Designated as safety issue: Yes ]
  • Survivorship [ Time Frame: Any Time ] [ Designated as safety issue: Yes ]
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[Trial of device that is not approved or cleared by the U.S. FDA]
[Trial of device that is not approved or cleared by the U.S. FDA]
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withheld
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Contact information is only displayed when the study is recruiting subjects
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NCT00754520
EU11
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[Redacted]
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ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP