Prospective, Randomized, Multi-Center Pilot Study on the Treatment of Unstable, Extraarticular Colles Fractures of the Distal Radius by Palmar Locking Plate, External Fixator or Kirschner Wires
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Functional status measured by DASH questionnaire
研究概览
简要总结
This is a prospective, randomized, multi-center pilot study of unstable extraarticular fractures of the distal radius with dorsal displacement of the distal fragment in elderly patients. The patients are randomly assigned to osteosynthesis with palmar locking plate, external fixator, or Kirschner wires.
The aim of this pilot study is to allow a sample size calculation for a main randomized controlled trial (RCT). The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters. Since this is a pilot study it is intended to generate a study hypothesis for the main RCT.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated, extraarticular, unstable Colles' fracture of the metaphysis of the distal radius (AO type A3)
- •Age 65 years or older
- •Patient agreed with and signed the "informed consent" form
排除标准
- •Fractures older than 7 days (more than 1 week between injury and treatment)
- •Other injuries of the hand
- •Other relevant injuries of the upper extremities
- •Open fracture
- •Patients with one hand missing
- •Clinical or radiological signs of any rheumatoid disease, osteoarthritis, or polyarthritis
- •Previous skeletal injury or severe soft tissue injury of the arm
- •History of drug or alcohol abuse
- •Patients unlikely to cooperate or attend all scheduled visits
- •Patients who have participated in any other device or drug clinical trial within the previous month
- •Patients with legal incompetence
结局指标
主要结局
Functional status measured by DASH questionnaire
次要结局
- Pain
- Range of motion (ROM)
- Grip strength
- Radiological parameters
- Feasibility