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NCT01818466 Clinical Trial

Anterior Tibiotalar Arthrodesis With Blade Plate Fixation

Arthritis Clinical Trial

Official title:
Anterior Tibiotalar Arthrodesis With Blade Plate Fixation in Treatment of Post-traumatic Arthritis Secondary to Pilon Fracture

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01818466
Other study ID # 57171
Secondary ID
Status Withdrawn
Phase N/A
First received February 5, 2013
Last updated June 27, 2016
Start date November 2012
Est. completion date May 2016

Study information
Verified date June 2016
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the clinical and radiographic outcomes of patients who have previously undergone tibiotalar arthrodesis using an anterior approach with blade-plate fixation for tibiotalar arthritis secondary to injury to the articular surface of the distal tibia.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- All patients whom have undergone anterior ankle arthrodesis with a blade plate construct, performed by a single surgeon, between January 2003 and July 2011 at the University of Utah or Primary Childrens Medical Center (PCMC) will be eligible for inclusion.

Exclusion Criteria:

- Any patient who is not 18 years of age or older will not be eligible for the study.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Utah

Outcome
Type Measure Description Time frame Safety issue
Primary Outcome Questionnaires relating to the patients current condition These questionnaires will include the FAOS, FADI, SF-36, PromisCAT, SMFA, and the DRAM. 1 Year after Surgery No
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