A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes
Withdrawn before enrolling · Phase 4
Conditions studied: Acquired Deformities of Toe
In brief
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.
Key facts
- Study ID
- NCT01927952
- Run by
- Susan Hassenbein
- People needed
- 0
- Starts
- 2013-09-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2013-12-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Full record on ClinicalTrials.gov
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