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A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

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ClinicalTrials.gov Identifier: NCT01927952
Recruitment Status : Withdrawn (Study withdrawn from IRB approval process by PI)
First Posted : August 23, 2013
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Acquired Deformities of Toe Procedure: Kirschner wire Procedure: Integra IPP-On PIP Fusion System Procedure: Stryker Smart-Toe Implant Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes
Study Start Date : September 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Kirschner wire
surgical fixation using a Kirschner wire
Procedure: Kirschner wire
Surgical fixation utiliziing Kirschner wire
Active Comparator: Integra IPP-On PIP Fusion System
surgical fixation utilizing the Integra IPP-On PIP Fusion System
Procedure: Integra IPP-On PIP Fusion System
surgical fixation utilizing the Integra IPP-On PIP Fusion System
Active Comparator: Stryker Smart-Toe implant
surgical fixation utilizing the Stryker Smart-Toe implant
Procedure: Stryker Smart-Toe Implant
surgical fixation utilizing the Stryker Smart-Toe Implant


Outcome Measures

Primary Outcome Measures :
  1. Complications [ Time Frame: 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 :
  1. Functional Outcome [ Time Frame: 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.

  2. Patient Satisfaction [ Time Frame: change from baseline to 12 weeks ]
    Will look at overall patient satisfaction with surgical care via a questionnaire administered to patients.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927952


Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Susan Hassenbein
Investigators
Principal Investigator: Umur Aydogan, MD Milton S. Hershey Medical Center
More Information

Publications:
Gadkari K, et al. A Prospective Comparison of a Permanent Intramedullary Device to K-Wire Fixation for Proximal Interphalangeal Joint Fusion: Early Results. Presented at AAOS Annual Meeting 2013, AOFAS Specialty Day

Responsible Party: Susan Hassenbein, Clinical Research Associate, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01927952     History of Changes
Other Study ID Numbers: IRB - 43245
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Keywords provided by Susan Hassenbein, Penn State Milton S. Hershey Medical Center:
hammertoe

Additional relevant MeSH terms:
Hammer Toe Syndrome
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases