PATIENT OUTCOME COMPARISON OF INTRAMEDULLARY LOCKED NAILING VERSUS NONOPERATIVE MANAGEMENT OF EXTRA-ARTICULAR AND MINIMALLY DISPLACED INTRA-ARTICULAR DISTAL RADIUS FRACTURES IN THE ELDERLY
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Change in Composite Patient Outcomes Over Time
研究概览
简要总结
This is a prospective multi-site study. Subjects with distal radius fractures will be enrolled. Subjects will be treated surgically with a Sonoma WRx™ device or managed non-operatively with a splint or cast. Subjects will be enrolled in each group according to physician's standard of care (either casting/splinting or surgery) for distal radius fractures. Subjects will be enrolled based on the study's inclusion/exclusion criteria with a final qualifying decision made by a group of three independent adjudicators. The final qualifying review should allow for similar patient groups within each arm of the study due to the variability that can arise in fracture classification. Review by the adjudicators should be completed within 1 week.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Closed extra-articular distal radius fracture or a minimally displaced intra-articular fracture
- •Fracture classified as an AO/OTA A2, A3, C1 or C2 with or without an ulnar styloid fracture
- •Must be treated within the first 14 days of injury,
- •Male or female greater than or equal to 65 years of age.
- •Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol
- •Ability to understand and provide written authorization for use and disclosure of personal health information
- •Fracture that can be treated closed with or without closed reduction
排除标准
- •Concomitant contralateral or ipsilateral upper extremity fractures
- •Ipsilateral ulna (excluding styloid) fracture
- •Open fracture
- •Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity
- •Unstable distal radioulnar joint after fracture fixation
- •Fractures where the transverse fracture line is less than 10mm from the distal radius joint surface
- •Artery or Nerve injury secondary to fracture
- •History of alcoholism
- •Currently on chemotherapy or radiation therapy
- •Currently on worker's compensation
- •Rheumatoid arthritis or other inflammatory arthropathies.
- •History of chronic pain issues or psychiatric disorder that precludes reliable follow-up.
结局指标
主要结局
Change in Composite Patient Outcomes Over Time
时间窗: Data will be collected at 2, 6, 12, 26, 52 weeks
Patient outcomes will be measured with the DASH, PRWE and a patient questionnaire.
次要结局
- Change in Composite Functional Outcomes Over Time(Data will be collected at 2, 6, 12, 26, 52 weeks)