Ankle Fracture Treatment in the Elderly

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01444144
First received: September 26, 2011
Last updated: November 11, 2013
Last verified: November 2013
  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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Retrospective record review tracking complications post-operatively until resolved.


Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (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

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01444144     History of Changes
Other Study ID Numbers: 146-2011
Study First Received: September 26, 2011
Last Updated: November 11, 2013
Health Authority: United States: Institutional Review Board

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
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014