Conservative Management Equally Effective to New Suture Anchor Technique for Acute Mallet Finger Deformity: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Extension deficit
研究概览
简要总结
This study aims to compare conservative treatment versus a new suture anchor technique for bony mallet finger in 29 patients.
详细描述
This study aims to compare conservative treatment versus a new suture anchor technique for bony mallet finger in 29 patients who presented to investigators' clinic between 2013 and 2015. Patients were randomly assigned to conservative or surgical treatment groups. Patients in the conservative group were followed with immobilization with aluminum splint and physical therapy. Patients in the surgical group were treated with investigators' new surgical suture anchor technique and then received physical therapy. The patients were followed for 12 months. Primary study outcomes were extension deficit, days to return to work and DIP flexion.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Wehbe Schneider type 1 - 2 and type A - B fractures
- •ability to provide closed reduction
- •patients' voluntariness
排除标准
- •Wehbe Schneider type C and type 3 fractures
研究组 & 干预措施
Conservative Treatment
Patients were treated with 6 weeks with splinting and were then started on physical therapy for 2 weeks.
干预措施: Conservative Treatment (Procedure)
Surgical Treatment
Patients were treated with the new suture anchor technique and after 6 weeks were started on physical therapy for 2 weeks.
干预措施: Suture anchor technique (Procedure)
结局指标
主要结局
Extension deficit
时间窗: 12 months
The inability to actively extend DIP joint to 0 degrees.
DIP flexion
时间窗: 12 months
The maximum angle of flexion at DIP joint
Days to return to work
时间窗: Starting from the date of the start of treatment until patients returns to work, assessed up to 12 months
Time to return to work
次要结局
未报告次要终点
研究者
Hayati Durmaz
Professor, MD
Istanbul University