[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.

Study NCT00561847 Information provided by DePuy Orthopaedics

First Received: November 20, 2007 Last Updated: September 22, 2009 History of Changes

Tracking Information
First Received Date ^ICMJE	November 20, 2007
Last Updated Date	September 22, 2009
Start Date ^ICMJE	January 2007
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE (submitted: November 20, 2007)	1. American Orthopaedic Foot and Ankle Society (AOFAS) 2. Short Musculoskeletal Function Assessment (SMFA) 3. Foot and Ankle Ability Measure (FAAM) 4. Work Productivity and Activity Impairment Questionnaire-Specific Health Problem (WPAI-SHP) 5. X-ray [ Time Frame: Pre-operative, 6 weeks, 3, 6, 12 , 24 and 36 month intervals. ]
Change History	Complete list of historical versions of study NCT00561847 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	[Trial of device that is not approved or cleared by the U.S. FDA]
Official Title ^ICMJE
Brief Summary
Detailed Description
Study Phase
Study Type ^ICMJE
Study Design ^ICMJE
Condition ^ICMJE
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withheld
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE
Gender
Ages
Accepts Healthy Volunteers
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00561847
Responsible Party	Mary Panozzo, DePuy Orthopaedics, Inc.
Study ID Numbers ^ICMJE	05062
Study Sponsor ^ICMJE	DePuy Orthopaedics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	DePuy Orthopaedics
Verification Date
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP