Clinical trial NCT01927952: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Acquired Deformities of Toe
Keywords: hammertoe
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2013-08-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Complications
timeFrame: change from baseline to 12 weeks
Secondary outcomes:
measure: Functional Outcome
timeFrame: change from baseline to 12 weeks
measure: Patient Satisfaction
timeFrame: change from baseline to 12 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Umur Aydogan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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
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.