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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01444144
Other study ID # 146-2011
Secondary ID
Status Completed
Phase N/A
First received September 26, 2011
Last updated September 29, 2017
Start date March 2011
Est. completion date April 3, 2011

Study information

Verified date September 2017
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date April 3, 2011
Est. primary completion date April 3, 2011
Accepts healthy volunteers No
Gender All
Age group 55 Years to 85 Years
Eligibility Inclusion Criteria:

- at least 55 years of age at time of surgery

- receiving treatment for ankle fractures

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Fracture union
Retrospective records review post-operatively until fracture resolved.

Locations

Country Name City State
United States UF&Shands Orthopaedics and Sports Medicine Institute Gainesville Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Status of Fracture Union Retrospective records review tracking ankle fractures post-operatively until fracture heals. Post-operatively until documentation of fracture healing, assessed up to seven months following surgery.
Secondary Post-operative Complications Retrospective record review tracking complications post-operatively until resolved. Post-operatively until documentation that complications resolved, assessed up to seven months following surgery.
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