A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

Phase 4

Withdrawn

• Conditions: Acquired Deformities of Toe
• Interventions: Procedure: Kirschner wire; Procedure: Stryker Smart-Toe Implant; Procedure: Integra IPP-On PIP Fusion System

• Registration Number: NCT01927952
• Lead Sponsor: Susan Hassenbein

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.

Study Timeline

• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-20
• Study First Posted: 2013-08-23
• Study Start: 2013-09
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kirschner wire	Kirschner wire	surgical fixation using a Kirschner wire
Stryker Smart-Toe implant	Stryker Smart-Toe Implant	surgical fixation utilizing the Stryker Smart-Toe implant
Integra IPP-On PIP Fusion System	Integra IPP-On PIP Fusion System	surgical fixation utilizing the Integra IPP-On PIP Fusion System

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States