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

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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.


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
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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mi
from
Hershey, PA
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