Prospective Study to Evaluate the Continued Safety and Effectiveness of the QuickFix Small Staple to Correct Hallux Valgus Interphalangeus
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change of Foot and Ankle Ability Measure (FAAM Sport)
研究概览
简要总结
The prospective, post-market, single-center clinical study will include 45 subjects who are candidates for surgery using the Arthrex QuickFix Small Staple for Akin osteotomy to correct hallux valgus interphalangeus. The purpose of the study is to evaluate the continued safety and effectiveness of the device. Device-related adverse events as well as patient reported outcomes (VAS, FFI, FAAM, VR-12) will be collected up to 1 year postoperative.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subject requires surgery using the Arthrex QuickFix Small Staple for Akin osteotomy.
- •Subject is 18 years of age or older.
- •Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).
- •Subject signed informed consent and is willing and able to comply with all study requirements.
排除标准
- •Insufficient quantity or quality of bone.
- •Blood supply limitations and previous infections which may retard healing.
- •Foreign-body sensitivity.
- •Any active infection or blood supply limitations.
- •Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
- •Subjects that are skeletally immature.
结局指标
主要结局
Change of Foot and Ankle Ability Measure (FAAM Sport)
时间窗: preoperatively, 3 months, 6 months and 12 months postoperative
Measuring foot functionality. Range 0-100 (0=worst, 100=best)
Change of Foot Function Index (FFI)
时间窗: preoperatively, 3 months, 6 months and 12 months postoperative
Measuring foot functionality. Range 0-100 (0=best, 100=worst)
Change of Veterans RAND 12 Iteam Health Survey (VR-12)
时间窗: preoperatively, 6 months and 12 months postoperative
Measuring quality of life. Range 0-100 (0=worst, 100=best)
Change of Visual Analogue Scale (VAS)
时间窗: preoperatively, 2 weeks, 6 week, 3 months, 6 months and 12 months postoperative
Measuring pain in the affected foot. Range 0-10 (0=best, 10=worst).
次要结局
未报告次要终点