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The Development of Flat Foot After Ankle Fractures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00507910
First Posted: July 27, 2007
Last Update Posted: July 21, 2011
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.
Information provided by:
Ottawa Hospital Research Institute
  Purpose
In this study we are trying to determine the incidence of flat foot (also called pes planus) among patients who have had an ankle fracture. As compared to the general population, it is predicted that the incidence of pes planus will be higher among people who have fractured their ankle.

Condition
Pes Planus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pes Planus After Weber B and C Ankle Fractures

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Estimated Enrollment: 25
Study Start Date: December 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:
Pes planus may develop following ankle fractures due to additional injuries that are sustained at the time of ankle fracture. If this study can demonstrate an association, further research would investigate how to effectively treat the pes planus early to prevent it from becoming a symptomatic problem.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion Criteria:

Patients will be considered eligible if:

  • They have sustained Weber type B or C ankle fractures and needed open reduction
  • They are 18 years of age or older
  • They are expected to be full weight bearing for at least 4 months to allow the potential of supporting structures to stretch and pes planus to develop

Exclusion Criteria:

  • Patients will be excluded if they already have flat foot in their non-fractured foot.
  • Patients with bilateral ankle fractures
  • Patients who are not competent to sign a consent form
  • A second fracture to the ankle
  • Pathological fractures
  • Patients with underlying cancer.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507910


Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Alan Giachino OHRI
  More Information

Responsible Party: Dr. Allan Giachino, MD, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00507910     History of Changes
Other Study ID Numbers: OHREB2006542
First Submitted: July 25, 2007
First Posted: July 27, 2007
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by Ottawa Hospital Research Institute:
ankle fracture
pes planus

Additional relevant MeSH terms:
Ankle Fractures
Flatfoot
Fractures, Bone
Wounds and Injuries
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities