A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes
Status: | Not yet recruiting |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/30/2013 |
Start Date: | September 2013 |
End Date: | December 2016 |
Contact: | Umur Aydogan, MD |
Email: | uaydogan@hmc.psu.edu |
Phone: | (717) 531-5638 |
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.
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
We found this trial at
1
site
500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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