NCT01293227终止不适用
The Effect of Intramedullary Locked Nail Versus Volar Locked Plating in the Treatment of Extra-articular and Minimally Displaced Intra-articular Distal Radius Fractures: A Prospective Randomized Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in Pain (to no pain)
研究概览
简要总结
This research project is a multi-year proposal, with the goals of answering and evaluating the following:
- Does an intramedullary locking device applied in an extra-articular distal radius fracture improve post operative pain, diminish hospitalization, improve early return to activity and function compared to a volar locked plate?
- Does an intramedullary locking device applied in an extra-articular distal radius fracture improve patient related outcome measures compared to a volar locked plate?
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following criteria must be met to be enrolled:
- •Have a closed extra-articular distal radius fracture or a minimally displaced intra-articular component
- •Have a fracture classified as an AO Type A or C1 with or without an ulnar styloid fracture
- •Be a male or non-pregnant female at least 18 years of age.
- •Understand the requirements of the study and able to provide a written informed consent and comply with the study protocol
- •Have the ability to understand and provide written authorization for use and disclosure of personal health information
- •Have a fracture that can be closed reduced to acceptable radiographic parameters (minimum of neutral volar tilt, greater than or equal to 15 degrees of radial inclination and at least 10 mm of radial height as compared to the opposite side)
排除标准
- •Subjects are excluded if:
- •Have any of the following conditions
- •Concomitant contralateral or ipsilateral upper extremity fractures
- •Ipsilateral ulna (excluding styloid) fracture
- •Open, multifragmentary fracture
- •Unstable distal radioulnar joint after fracture fixation
- •Artery or Nerve injury secondary to fracture
- •Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity
- •Currently on chemotherapy or radiation therapy
- •History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
- •History of uncontrolled diabetes
- •History of active rheumatologic disease with deformity
- •History of chronic pain issues, psychiatric disorder which precludes reliable follow-up
- •Unable to provide consent for the study
- •Unable to make the follow-up appointments required of the study
结局指标
主要结局
Change in Pain (to no pain)
时间窗: Baseline to week 52 after surgery
Postoperative pain will be monitored by recording of the consumption of narcotic pain medications converted to morphine equivalents. Participants will record medications taken in a Pain Diary. They will also be asked to complete a Visual Analog scale questionnaire regarding their pain.
次要结局
- Change in range of motion measurements(Basline to week 52 after surgery)
- Grip and Pinch(Baseline to week 52 after surgery)
研究者
研究点 (2)
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