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.
This is a prospective, randomized study and will assist us in ascertaining which of the three tested interventions has the most beneficial outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Surgical fixation utiliziing Kirschner wire
surgical fixation utilizing the Integra IPP-On PIP Fusion System
surgical fixation utilizing the Stryker Smart-Toe Implant
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Complications
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.
Time frame: change from baseline to 12 weeks
Functional Outcome
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.
Time frame: change from baseline to 12 weeks
Patient Satisfaction
Will look at overall patient satisfaction with surgical care via a questionnaire administered to patients.
Time frame: change from baseline to 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.