Status:

COMPLETED

Prospective Randomized Evaluation of a Two and Three Piece Total Ankle Replacement

Lead Sponsor:

Duke University

Conditions:

Ankle Osteoarthritis

Eligibility:

All Genders

18-95 years

Phase:

NA

Brief Summary

This is a randomized study to prospectively compare and evaluate the functional outcome and patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either the STAR or Sal...

Eligibility Criteria

Inclusion

  • Adult patients (age \> 18 years) who will benefit from a total ankle replacement, as determined by Drs. Nunley, DeOrio, or Easley, with the aid of the physical exam and routine radiography treated at Duke University Medical Center and who have no medical conditions that would represent contraindications to surgery or anesthesia will be asked to participate in this study.

Exclusion

  • The only excluded patients will be those who do not choose to participate in this study, have a weight greater than 250lbs, or do not meet the minimum age of 18 years.

Key Trial Info

Start Date :

October 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 4 2020

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT01504438

Start Date

October 1 2011

End Date

March 4 2020

Last Update

May 5 2021

Active Locations (1)

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1

Duke Medical Plaza Page Road

Durham, North Carolina, United States, 27703