A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

Susan Hassenbein

Status and phase: Withdrawn; Phase 4

Conditions: Acquired Deformities of Toe

Treatments: Procedure: Integra IPP-On PIP Fusion System; Procedure: Stryker Smart-Toe Implant; Procedure: Kirschner wire

Study type: Interventional

Funder types: Other

Identifiers

NCT01927952

IRB - 43245

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Kirschner wire

Active Comparator group

Description:

surgical fixation using a Kirschner wire

Treatment:

Procedure: Kirschner wire

Integra IPP-On PIP Fusion System

Active Comparator group

Description:

surgical fixation utilizing the Integra IPP-On PIP Fusion System

Treatment:

Procedure: Integra IPP-On PIP Fusion System

Stryker Smart-Toe implant

Active Comparator group

Description:

surgical fixation utilizing the Stryker Smart-Toe implant

Treatment:

Procedure: Stryker Smart-Toe Implant