Functional Treatment of Non-thumb Metacarpal Shaft Fractures. Randomized Study Evaluating Buddy Taping Versus Splint on Functional Recovery of the Hand
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Quick Dash
研究概览
简要总结
The goal of this clinical trial is to see if buddy tape can treat shaft fracture of hand long fingers as well as splint.
The main question it aims to answer is: Two months after the fracture, are the hand activities as good with buddy taping as with splint? Researchers will compare buddy tape group to splint group to see if the strength of the arm is not lower with buddy tape.
Participants will attend 4 visits after receiving either buddy tape or splint, to control their hand strength and the correct healing of their franture.
详细描述
Patients will be identified in the emergency ward after x-rays are positive for a non-thumb metacarpal fracture. If they consent to participate in the study, they will be put into either the buddy taping or the short arm splint group. This decision will be made through randomization, and the physician will not select which group the patient is in.
As in routine practice, the patients are seen again on D15 ± 3 days, D30 ± 5 days and D60 ± 5 days in an orthopedic consultation with X-ray to control the hand face, strict profile and 3/4. Both devices are removed at the check-up consultation on day 30 ± 5 days.
The patients will then attend the end of trial visit at Day 90 ± 5 days in an orthopedic consultation with X-ray.
No specific act is added by this research.
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 patient
- •Fingers 2 to 5 metacarpal shaft fracture, little or no displacement
- •Tilt less than or equal to thirty degrees
- •No rotation disorder
- •Patient who has given consent to participate in the study and has signed an informed consent
排除标准
- •Surgical treatment indicated
- •Patient pregnant or likely to be pregnant
- •Patient who does not speak or understand French
- •Subject under guardianship or curatorship
- •Subject not beneficiary of a social security system.
研究组 & 干预措施
splint
干预措施: splint (Device)
buddy
干预措施: buddy tape (Device)
结局指标
主要结局
Quick Dash
时间窗: day 60
Auto questionnaire evaluating the disabilities of the arm, shoulder and hand
次要结局
- TAM(day 0,15,30,60 and 90)
- clamp force(day 0,15,30,60 and 90)
- Grip force(day 0,15,30,60 and 90)
- TPM(day 0,15,30,60 and 90)