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Investigation of the Added Value of a Big Toe Hinged Brace for the Treatment of Hallux Rigidus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00284284
Recruitment Status : Withdrawn
First Posted : January 31, 2006
Last Update Posted : May 12, 2009
Sponsor:
Information provided by:
University Hospital, Ghent

Tracking Information
First Submitted Date  ICMJE January 30, 2006
First Posted Date  ICMJE January 31, 2006
Last Update Posted Date May 12, 2009
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2006)
Mobility of the big toe joint
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2006)
Agility of the big toe joint
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of the Added Value of a Big Toe Hinged Brace for the Treatment of Hallux Rigidus
Official Title  ICMJE Investigation of the Added Value of a Big Toe Hinged Brace for the Treatment of Hallux Rigidus
Brief Summary Comparison of the added value of a rehabilitation brace to standard rehabilitation by physiotherapy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hallux Rigidus
Intervention  ICMJE Device: Use of a rehabilitation brace
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Estimated Enrollment  ICMJE
 (submitted: January 30, 2006)
50
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hallux rigidus

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Belgium
 
Administrative Information
NCT Number  ICMJE NCT00284284
Other Study ID Numbers  ICMJE 2005/171
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party René Verdonk, University Hospital Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rene Verdonk, MD, PhD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date April 2009

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