Study on the Immediate Recovery and Satisfaction After Distal Radius Fracture During the First Three Months- a PROM Based Observational Study With Day-to-day Records
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Patient-reported hand function
研究概览
简要总结
Distal radius fracture is the most common fracture in Sweden, but little is known about the patient's experience of pain and hand function during the first three months after the injury. This observational study will provide detailed information on a daily basis regarding pain, use of analgesic drugs, use of splints and hand function as measured weekly by a condition-specific questionnaire.
详细描述
Two hundred patients who are treated conservatively in a cast and one hundred patients who have undergone surgery will be asked to complete a questionnaire with the following outcome measures for three months:
- Pain (day-by-day registration on a Likert scale, range 0-10)
- Analgesic used (day-by-day registration of specific drug, dose and number)
- PRWE (Patient Reported Wrist Evaluation form, week-by-week registration)
- Use of and evaluation of efficacy of prefabricated wrist splints (week-by-week registration)
- Details of sick leave and return to work at completion of the questionnaire at three months.
The study is entirely PROM-based and the patient will not require any additional appointments.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Unilateral distal radius fractures in patients without any other significant injuries regardless of ligament injuries and ulnar fractures.
- •Signed written consent
排除标准
- •Compound injuries
- •Open fractures
- •Patients with post traumatic function deficits at any level in the affected arm prior to the distal radius fracture.
- •Patients with function deficits in the affected arm due to other medical conditions (e.g. Parkinsons disease, Rheumatoid Arthritis)
- •Reduced mental capacity (e.g. dementia, substance abuse)
研究组 & 干预措施
Cast
Patients that are conservatively treated (in a cast, either without or with reduction)
干预措施: Surgical treatment of fracture (Procedure)
Surgery
Patients that undergo surgical treatment (regardless of method)
干预措施: Treatment of fracture by forearm cast (Procedure)
结局指标
主要结局
Patient-reported hand function
时间窗: Every week for three months
Patient Rated Wrist Evaluation (PRWE) questionnaire
次要结局
- Wrist splint usage(Every week for three months)
- Analgesics(Every day for three months)
- Day-by-day pain record(Every day for three months)
研究者
Joakim Stromberg
senior consultant,
Sahlgrenska University Hospital