NCT00828685已完成不适用
Early Functional Outcomes After Closed Reduction Percutaneous Pinning vs. Open Reduction Internal Fixation of Distal Radius Fractures: A Prospective Randomized Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Wrist range of motion measurement. As well as recorded score from the DASH questionnaire.
研究概览
简要总结
The purpose of this study is to compare early return to function in patients treated with closed reduction percutaneous pinning and open reduction internal fixation in displaced fractures of the distal radius.
Hypothesis: Wrist range of motion, grip strength and outcome at 2-3 months after injury are better in patients treated with open reduction, internal fixation (ORIF) than in patients treated with closed reduction percutaneous pinning techniques (CRPP). In addition patients treated with ORIF return to work at faster rates.
研究设计
- 研究类型
- Interventional
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
- •18 years or greater
- •Patient functions independently
- •Dorsally displaced, extra-articular fracture (Colles' fracture); or simple intra-articular fracture with a single split between the scaphoid and lunate facets.
- •Isolated injury (no other injuries).
- •One of the following criteria:
- •Substantial initial displacement
- •Greater than 20 degrees dorsal angulation of the articular surface on the lateral view.
- •Greater than 100% loss of apposition.
- •Greater than 5 millimeters of shortening by ulnar variance on the posteroanterior radiograph.
- •Greater than 2 millimeters articular incongruity (step or gap).
- •Both dorsal and volar comminution. Inadequate initial manipulative reduction
- •Greater than 5 degrees of dorsal angulation of the articular surface on the lateral radiograph.
- •Greater than 3 millimeters of radial shortening by ulnar variance on the posteroanterior radiograph.
- •Greater than 2 millimeters articular incongruity.
- •Bayonett apposition of the volar cortex.
- •Less than 15 degrees of ulnarward inclination of the articular surface in the posteroanterior radiograph. Loss of reduction within 3 weeks of injury.
- •Any of the following changes in alignment from the initial post- reduction radiographs qualify:
- •5 degrees or greater loss of palmar tilt of the articular surface on the lateral radiograph.
- •2 millimeters or greater loss of radial height by ulnar variance on the posteroanterior radiograph.
- •5 degrees or greater loss of ulnarward inclination of the articular surface of the distal radius on the posteroanteriorradiograph.
- •2 millimeters or greater articular incongruity.
排除标准
- •More complex articular fractures (i.e. anything more than a simple sagittal split between the scaphoid and lunate facets).
- •Volarly displaced fractures.
- •Infirm patients.
- •Patients that rely on others for basic functional activities.
- •Open fractures
- •Fractures associated with neurovascular injury.
- •Fractures associated with major head, neurological, or visceral injuries that will inhibit the ability to participate in a structured exercise program.
- •Associated musculoskeletal injuries to the same arm.
结局指标
主要结局
Wrist range of motion measurement. As well as recorded score from the DASH questionnaire.
时间窗: 3 months post surgery
次要结局
- Range of motion measured in wrist and a scored DASH questionnaire(1 year after surgery)
研究者
Tamara Rozental
Associate Professor of Orthopedic Surgery
Beth Israel Deaconess Medical Center
研究点 (2)
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