Acquired Deformities of Toe
Conditions
Keywords
hammertoe
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 description
This is a prospective, randomized study and will assist us in ascertaining which of the three tested interventions has the most beneficial outcome.
Interventions
PROCEDUREKirschner wire
Surgical fixation utiliziing Kirschner wire
PROCEDUREIntegra IPP-On PIP Fusion System
surgical fixation utilizing the Integra IPP-On PIP Fusion System
PROCEDUREStryker Smart-Toe Implant
surgical fixation utilizing the Stryker Smart-Toe Implant
Sponsors
Susan Hassenbein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcome | 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 | change from baseline to 12 weeks | Will look at overall patient satisfaction with surgical care via a questionnaire administered to patients. |
Countries
United States
Outcome results
None listed