Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes: A Multicenter Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Disabilities of the Arm, Shoulder, and Hand (DASH) Score
研究概览
简要总结
The purpose of this randomized control trial will be to determine whether the duration of bridge plate fixation of distal radius fractures can be reduced to 6-8 weeks without worsening of functional outcomes relative to the current standard of greater than 12 weeks of fixation. The secondary aim of the study is to determine whether a reduced duration of bridge plate fixation leads to an increase in wrist range of motion following plate removal compared to the standard duration of fixation. 100 patients with comminuted distal radius fractures that are indicated for bridge plate fixation will be randomized to the Accelerated Removal arm (n = 50) or the Standard Removal arm (n = 50).
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
- •Fracture of the distal radius indicated for operative treatment using bridge plate fixation
- •Age 18 years or greater
- •Capacity to provide informed consent
排除标准
- •Bridge plate fixation in the setting of revision surgery for prior nonunion or malunion
- •Bilateral distal radius fractures (prevents accurate measurement of postoperative range of motion and strength of the injured extremity without a normal contralateral extremity for comparison)
- •Pathologic fractures
- •Patients that will be unable to complete the necessary follow up, including incarcerated patients
结局指标
主要结局
Change in Disabilities of the Arm, Shoulder, and Hand (DASH) Score
时间窗: Baseline, Week 104
30-item questionnaire that asks the patient to rate their difficulty with common functional tasks and the severity of upper extremity symptoms over the past week. DASH is reported on a scale of 0-100 with lower scores indicating less severe symptoms and superior function. A decrease in scores indicates symptoms became less severe and function improved during the observational period.
次要结局
- Change in Patient-Related Wrist Evaluation (PRWE) Questionnaire Score(Baseline, Week 104)
- Change in Radial Height(Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104)
- Isometric Force: Wrist Extension Force Relative to Contralateral Side(Up to Week 104)
- Change in Radial Inclination(Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104)
- Range of Motion: Flexion-Extension Arc Relative to Contralateral Side(Up to Week 104)
- Isometric Force: Grip Force Relative to Contralateral Side(Up to Week 104)
- Isometric Force: Wrist Flexion Force Relative to Contralateral Side(Up to Week 104)
- Change in Volar Tilt(Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104)
- Change in Ulnar Variance(Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104)
- Range of Motion: Pronosupination Arc Relative to Contralateral Side(Up to Week 104)
- Range of Motion: Ulnar-Radial Deviation Arc Relative to Contralateral Side(Up to Week 104)
- Incidence of Nonunion at Surgical Site(Up to Week 104)