A Prospective Randomized Comparison of Three Methods for Fixation of Hammertoes
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Complications
研究概览
简要总结
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.
详细描述
This is a prospective, randomized study and will assist us in ascertaining which of the three tested interventions has the most beneficial outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Complications
时间窗: change from baseline to 12 weeks
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.
次要结局
- Functional Outcome(change from baseline to 12 weeks)
- Patient Satisfaction(change from baseline to 12 weeks)
研究者
Susan Hassenbein
Clinical Research Associate
Milton S. Hershey Medical Center