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A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

Primary Purpose

Acquired Deformities of Toe

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Kirschner wire

Integra IPP-On PIP Fusion System

Stryker Smart-Toe Implant

About this trial

This is an interventional treatment trial for Acquired Deformities of Toe focused on measuring hammertoe

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Kirschner wire

Integra IPP-On PIP Fusion System

Stryker Smart-Toe implant

Arm Description

surgical fixation using a Kirschner wire

surgical fixation utilizing the Integra IPP-On PIP Fusion System

surgical fixation utilizing the Stryker Smart-Toe implant

Outcomes

Primary Outcome Measures

Complications

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

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

Will look at overall patient satisfaction with surgical care via a questionnaire administered to patients.

Full Information

NCT ID

NCT01927952

First Posted

August 19, 2013

Last Updated

December 3, 2013

Sponsor

Susan Hassenbein

1. Study Identification

Unique Protocol Identification Number

NCT01927952

Brief Title

A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

Official Title

A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Withdrawn

Why Stopped

Study withdrawn from IRB approval process by PI

Study Start Date

September 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Susan Hassenbein

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acquired Deformities of Toe

Keywords

hammertoe

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Kirschner wire

Arm Type

Active Comparator

Arm Description

surgical fixation using a Kirschner wire

Arm Title

Integra IPP-On PIP Fusion System

Arm Type

Active Comparator

Arm Description

surgical fixation utilizing the Integra IPP-On PIP Fusion System

Arm Title

Stryker Smart-Toe implant

Arm Type

Active Comparator

Arm Description

surgical fixation utilizing the Stryker Smart-Toe implant

Intervention Type

Procedure

Intervention Name(s)

Kirschner wire

Intervention Description

Surgical fixation utiliziing Kirschner wire

Intervention Type

Procedure

Intervention Name(s)

Integra IPP-On PIP Fusion System

Intervention Description

surgical fixation utilizing the Integra IPP-On PIP Fusion System

Intervention Type

Procedure

Intervention Name(s)

Stryker Smart-Toe Implant

Intervention Description

surgical fixation utilizing the Stryker Smart-Toe Implant

Primary Outcome Measure Information:

Title

Complications

Description

Time Frame

change from baseline to 12 weeks

Secondary Outcome Measure Information:

Title

Functional Outcome

Description

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.

Time Frame

change from baseline to 12 weeks

Title

Patient Satisfaction

Description

Will look at overall patient satisfaction with surgical care via a questionnaire administered to patients.

Time Frame

change from baseline to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Umur Aydogan, MD

Organizational Affiliation

Milton S. Hershey Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn State Milton S. Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10694020

Citation

Coughlin MJ, Dorris J, Polk E. Operative repair of the fixed hammertoe deformity. Foot Ankle Int. 2000 Feb;21(2):94-104. doi: 10.1177/107110070002100202.

Results Reference

background

PubMed Identifier

3656240

Citation

Reece AT, Stone MH, Young AB. Toe fusion using Kirschner wire. A study of the postoperative infection rate and related problems. J R Coll Surg Edinb. 1987 Jun;32(3):158-9. No abstract available.

Results Reference

background

PubMed Identifier

8520664

Citation

Zingas C, Katcherian DA, Wu KK. Kirschner wire breakage after surgery of the lesser toes. Foot Ankle Int. 1995 Aug;16(8):504-9. doi: 10.1177/107110079501600809.

Results Reference

background

PubMed Identifier

22381341

Citation

Klammer G, Baumann G, Moor BK, Farshad M, Espinosa N. Early complications and recurrence rates after Kirschner wire transfixion in lesser toe surgery: a prospective randomized study. Foot Ankle Int. 2012 Feb;33(2):105-12. doi: 10.3113/FAI.2012.0105.

Results Reference

background

PubMed Identifier

8563920

Citation

Lehman DE, Smith RW. Treatment of symptomatic hammertoe with a proximal interphalangeal joint arthrodesis. Foot Ankle Int. 1995 Sep;16(9):535-41. doi: 10.1177/107110079501600904.

Results Reference

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PubMed Identifier

15132935

Citation

Caterini R, Farsetti P, Tarantino U, Potenza V, Ippolito E. Arthrodesis of the toe joints with an intramedullary cannulated screw for correction of hammertoe deformity. Foot Ankle Int. 2004 Apr;25(4):256-61. doi: 10.1177/107110070402500411.

Results Reference

background

PubMed Identifier

7550962

Citation

Sarrafian SK. Correction of fixed hammertoe deformity with resection of the head of the proximal phalanx and extensor tendon tenodesis. Foot Ankle Int. 1995 Jul;16(7):449-51. doi: 10.1177/107110079501600714.

Results Reference

background

PubMed Identifier

22224327

Citation

Konkel KF, Sover ER, Menger AG, Halberg JM. Hammer toe correction using an absorbable pin. Foot Ankle Int. 2011 Oct;32(10):973-8. doi: 10.3113/FAI.2011.0973.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

16309613

Citation

Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113.

Results Reference

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A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

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