A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

Study Overview
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Brief Summary
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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 Description
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This is a prospective, randomized study and will assist us in ascertaining which of the three tested interventions has the most beneficial outcome.

Official Title
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A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

Conditions
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Acquired Deformities of Toe

Intervention / Treatment
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* Procedure: Kirschner wire
* Procedure: Integra IPP-On PIP Fusion System
* Procedure: Stryker Smart-Toe Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects (greater than or equal to 18 years of age) diagnosed with hammertoe deformity, acquired (ICD9 734.5) requiring surgical fixation Subject has given voluntary, written informed consent to participate in this clinical investigation. Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits Subject must be comfortable with speaking, reading, and understanding questions and providing responses in an available translated language. Exclusion Criteria: Subjects less than 18 years of age Subjects with peripheral or central neurologic disease causing neurologic symptoms, including pain, dysthesia, or numbness of the operative leg Subjects diagnosed with complicated diabetes mellitus with noted neuropathy, diagnosed by the 10-g monofilament test Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kirschner wire<br>surgical fixation using a Kirschner wire | Procedure: Kirschner wire<br>* Surgical fixation utiliziing Kirschner wire<br>|
| Active Comparator: Integra IPP-On PIP Fusion System<br>surgical fixation utilizing the Integra IPP-On PIP Fusion System | Procedure: Integra IPP-On PIP Fusion System<br>* surgical fixation utilizing the Integra IPP-On PIP Fusion System<br>|
| Active Comparator: Stryker Smart-Toe implant<br>surgical fixation utilizing the Stryker Smart-Toe implant | Procedure: Stryker Smart-Toe Implant<br>* surgical fixation utilizing the Stryker Smart-Toe Implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | change from baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | change from baseline to 12 weeks | 
| Patient Satisfaction | Will look at overall patient satisfaction with surgical care via a questionnaire administered to patients. | change from baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hammertoe