A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes
NCT ID: NCT01927952
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2013-09-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Kirschner wire
surgical fixation using a Kirschner wire
Kirschner wire
Surgical fixation utiliziing Kirschner wire
Integra IPP-On PIP Fusion System
surgical fixation utilizing the Integra IPP-On PIP Fusion System
Integra IPP-On PIP Fusion System
surgical fixation utilizing the Integra IPP-On PIP Fusion System
Stryker Smart-Toe implant
surgical fixation utilizing the Stryker Smart-Toe implant
Stryker Smart-Toe Implant
surgical fixation utilizing the Stryker Smart-Toe Implant
Interventions
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Kirschner wire
Surgical fixation utiliziing Kirschner wire
Integra IPP-On PIP Fusion System
surgical fixation utilizing the Integra IPP-On PIP Fusion System
Stryker Smart-Toe Implant
surgical fixation utilizing the Stryker Smart-Toe Implant
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Susan Hassenbein
OTHER
Responsible Party
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Susan Hassenbein
Clinical Research Associate
Principal Investigators
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Umur Aydogan, MD
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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
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.
Other Identifiers
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IRB - 43245
Identifier Type: -
Identifier Source: org_study_id