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Study Status: Withdrawn
Recruit Status: Withdrawn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 ]

Will look at number of participants with complications/adverse events including: floating toe, recurrence of hammertoe, soft tissue infection, medial/lateral mal-alignment at PIP joint, plantar flexion/hyperextension mal-alignment at DIP joint, rotation of toe and need for revision surgery.


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