Acquired Deformities of Toe Clinical Trial
Official title:
A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Susan Hassenbein |
United States,
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. — View Citation
Coughlin MJ, Dorris J, Polk E. Operative repair of the fixed hammertoe deformity. Foot Ankle Int. 2000 Feb;21(2):94-104. — View 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
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. — View 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. — View Citation
Lehman DE, Smith RW. Treatment of symptomatic hammertoe with a proximal interphalangeal joint arthrodesis. Foot Ankle Int. 1995 Sep;16(9):535-41. — View 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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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. | change from baseline to 12 weeks | No |
| Secondary | Patient Satisfaction | Will look at overall patient satisfaction with surgical care via a questionnaire administered to patients. | change from baseline to 12 weeks | No |