Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- appearance score
研究概览
简要总结
This study is based on human anatomical data and uses computer-aided engineering (CAE) software such as biomedical image processing software, reverse engineering software, CAD software, and finite element analysis software to create a three-dimensional bracing model. With the help of 3D printing technology, we have developed personalized brace, completed the personalized rapid design and optimization of the three series of support equipment products such as the posterior cruciate ligament brace, ankle ankle brace, and shoulder brace.
详细描述
The traditional brace mainly includes small splints or gypsums. The manufacturing process is rough, and the flexibility is poor. In recent years, with the development of orthopedic surgery, rehabilitation concept, modern polymer materials, and biomechanics, great progress has been made in R&D, production, and assembly of orthoses. In developed countries, orthoses is not only widely used after orthopedic surgery and the department of rehabilitation, but it has become the main auxiliary device for sports trauma surgery, immobilization, treatment, and rehabilitation training. Leading bracing company such as DJO has developed multi-brand correction devices such as Aircast®, Chattanooga, CMF, COMPEX®, DonJoy®, Empi® and ProCare®. However, these braces are not designed and manufactured based on patients. Individually designed products for anatomical structures still have many problems in clinical applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients accepting arthroscopic surgery of the shoulder, posterior cruciate ligament reconstruction surgery, Achilles tendon rupture repair surgery.
排除标准
- •Severe peripheral ligament injury of should, knee and ankle.
研究组 & 干预措施
Personalized brace group
Personalized brace for patients
干预措施: Rehabilitation brace (Device)
Conventional brace group
Conventional brace for patients
干预措施: Rehabilitation brace (Device)
结局指标
主要结局
appearance score
时间窗: six weeks after injury
Patient's preference for appearance
comfort score
时间窗: two weeks after injury
Patient comfort score
Convenience score
时间窗: six weeks after injury
Convenience of adjustment during rehabilitation
Satisfaction score
时间窗: six weeks after injury
Overall satisfaction of patients
次要结局
未报告次要终点
研究者
Jia-kuo yu
Peking University Third Hospital
Peking University Third Hospital