Clinical Trial: A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes
Brief Summary: The purpose of this research project is to compare three different methods for fixation of hammertoe deformities: (1) Kirschner wire; (2) Integra IPP-ON PIP Fusion System; and (3) Stryker Smart-Toe implant.
Detailed Summary: This is a prospective, randomized study and will assist us in ascertaining which of the three tested interventions has the most beneficial outcome.
Sponsor: Susan Hassenbein
Current Primary Outcome: Complications [ Time Frame: change from baseline to 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Functional Outcome [ Time Frame: change from baseline to 12 weeks ]Will look at functional outcomes of patients as reported in the Foot and Ankle Ability Measure (FAAM) questionnaire administered to patients to assess their function pre- and post-surgery.
- Patient Satisfaction [ Time Frame: change from baseline to 12 weeks ]Will look at overall patient satisfaction with surgical care via a questionnaire administered to patients.
Original Secondary Outcome: Same as current
Information By: Milton S. Hershey Medical Center
Dates:
Date Received: August 19, 2013
Date Started: September 2013
Date Completion: December 2016
Last Updated: December 3, 2013
Last Verified: December 2013