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Ankle Fracture Treatment in the Elderly

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01444144
First Posted: September 30, 2011
Last Update Posted: October 3, 2017
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 (Responsible Party):
University of Florida
  Purpose
The purpose of this study is to track surgical outcomes and post-operative course in patients 55 years of age or older treated for ankle fractures.

Condition Intervention
Ankle Fracture Other: Fracture union

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Ankle Fracture Treatment in the Elderly, at Risk Population

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Status of Fracture Union [ Time Frame: Post-operatively until documentation of fracture healing, assessed up to seven months following surgery. ]
    Retrospective records review tracking ankle fractures post-operatively until fracture heals.


Secondary Outcome Measures:
  • Post-operative Complications [ Time Frame: Post-operatively until documentation that complications resolved, assessed up to seven months following surgery. ]
    Retrospective record review tracking complications post-operatively until resolved.


Enrollment: 118
Actual Study Start Date: March 2011
Study Completion Date: April 3, 2011
Primary Completion Date: April 3, 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ankle Fracture
Patients aged 55 years at time of surgery undergoing treatment for ankle fractures.
Other: Fracture union
Retrospective records review post-operatively until fracture resolved.

Detailed Description:
This study seeks to describe and track surgical outcomes associated with the use of a minimally invasive surgical technique used to treat ankle fractures in at-risk patients 55 years of age or older
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
At-risk population, at least 55 years of age at time of surgery receiving treatment for ankle fractures.
Criteria

Inclusion Criteria:

  • at least 55 years of age at time of surgery
  • receiving treatment for ankle fractures

Exclusion Criteria:

  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): NCT01444144


Locations
United States, Florida
UF&Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Kalia K Sadasivan, M.D. University of Florida Department of Orthopaedics and Rehabilitation
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01444144     History of Changes
Other Study ID Numbers: 146-2011
First Submitted: September 26, 2011
First Posted: September 30, 2011
Last Update Posted: October 3, 2017
Last Verified: September 2017

Keywords provided by University of Florida:
Ankle
Fracture
Elderly
At-risk Population
Ankle Fracture in at-risk elderly population

Additional relevant MeSH terms:
Fractures, Bone
Ankle Fractures
Wounds and Injuries