[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:
NCT00561847
First received: November 20, 2007
Last updated: April 2, 2013
Last verified: NA

November 20, 2007
April 2, 2013
January 2007
Not Provided
Not Provided
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. ]
Complete list of historical versions of study NCT00561847 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
[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]
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withheld
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00561847
05062
Not Provided
[Redacted]
[Redacted]
Not Provided
Not Provided
[Redacted]
Not Provided

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP