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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ankle Fractures
Wounds and Injuries

ClinicalTrials.gov processed this record on August 20, 2014