A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

This study has been withdrawn prior to enrollment.
(Study withdrawn from IRB approval process by PI)
Sponsor:
Information provided by (Responsible Party):
Susan Hassenbein, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01927952
First received: August 19, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Complications [ Time Frame: change from baseline to 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Functional Outcome [ Time Frame: change from baseline to 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: change from baseline to 12 weeks ] [ Designated as safety issue: No ]
    Will look at overall patient satisfaction with surgical care via a questionnaire administered to patients.


Enrollment: 0
Study Start Date: September 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 19, 2013
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
hammertoe

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

ClinicalTrials.gov processed this record on July 23, 2014