Ankle Fracture Treatment in the Elderly
This study is ongoing, but not recruiting participants.
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01444144
First received: September 26, 2011
Last updated: October 26, 2012
Last verified: October 2012
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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 2013 |
| Estimated Primary Completion Date: | March 2013 (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: | October 26, 2012 |
| 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 May 22, 2013