A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes

NCT01927952 | Withdrawn Phase 4

• 1 other identifier: IRB - 43245
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Deformities of Toe

Keywords

hammertoe

Outcome Measures

Primary Outcomes (1)

• 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.

  change from baseline to 12 weeks

Secondary Outcomes (2)

• Functional Outcome

  change from baseline to 12 weeks

• Patient Satisfaction

  change from baseline to 12 weeks

Study Arms (3)

Kirschner wire

ACTIVE COMPARATOR

surgical fixation using a Kirschner wire

Procedure: Kirschner wire

Integra IPP-On PIP Fusion System

ACTIVE COMPARATOR

surgical fixation utilizing the Integra IPP-On PIP Fusion System

Procedure: Integra IPP-On PIP Fusion System

Stryker Smart-Toe implant

ACTIVE COMPARATOR

surgical fixation utilizing the Stryker Smart-Toe implant

Procedure: Stryker Smart-Toe Implant

Interventions

Kirschner wire PROCEDURE

Surgical fixation utiliziing Kirschner wire

Kirschner wire

Integra IPP-On PIP Fusion System PROCEDURE

surgical fixation utilizing the Integra IPP-On PIP Fusion System

Integra IPP-On PIP Fusion System

Stryker Smart-Toe Implant PROCEDURE

surgical fixation utilizing the Stryker Smart-Toe Implant

Stryker Smart-Toe implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Susan Hassenbein: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (10)

• 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.

  PMID: 10694020 BACKGROUND

• 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.

  PMID: 3656240 BACKGROUND

• 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.

  PMID: 8520664 BACKGROUND

• 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.

  PMID: 22381341 BACKGROUND

• 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.

  PMID: 8563920 BACKGROUND

• 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.

  PMID: 15132935 BACKGROUND

• 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.

  PMID: 7550962 BACKGROUND

• 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.

  PMID: 22224327 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 16309613 BACKGROUND

MeSH Terms

Conditions

Hammer Toe Syndrome

Interventions

Bone Wires

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Umur Aydogan, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Associate

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 23, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

US (1)