NCT03290586已完成不适用
Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis; the Evaluation of a Novel, Single Use Sterile, Disposable Delivery System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Union Rates
研究概览
简要总结
This is a longitudinal, multi-center study to be conducted in at least five institutions from the private surgeon offices. These surgeons will collect data from X-rays, wound complications \and hardware complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Painful Hallux Limitus or Rigidus
- •Painful Geriatric Hallux Valgus
- •Failed prior 1st MTP joint arthroplasty (hemi-total)
- •Arthritis of any etiology other than degenerative causes
排除标准
- •Age less than 18 years
- •Pregnant Females
- •Active or prior infection at the target joint
- •Immunocompromised patients
- •Patients unwilling to sign informed consent
- •Patient's unwilling to participate the in study protocol
- •Subject with known sensitivity to titanium implants
结局指标
主要结局
Union Rates
时间窗: 12 months
Confirm union rates comparable to existing outcomes complications with our proposed construct.
Hardware Failures
时间窗: 12 months
Evaluate hardware failures with our proposed construct.
Complications
时间窗: 12 months
Evaluate complications with the procedure
次要结局
- Cost Data(12 months)
研究者
John Levin
Principal Investigator
JEM Research Institute
研究点 (1)
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