DRF Reposition Manual Reduction vs Finger-trap Traction (RepoDRF2)
Unterschied Der Reposition in Bruchspaltanästhesie Zur Reposition im Aushang Bei Einer Distalen Radiusfraktur - Eine Prospektiv Randomisierte Studie
研究概览
详细说明
Participants have sustained a distal radius fracture treated with cast immobilization. Two common conservative management approaches are being compared: (1) closed reduction under a local anesthetic (hematoma block) followed by traction and casting, and (2) immobilization after traction alone without formal reduction under anesthesia.
While the first method aims to restore anatomical alignment initially, loss of reduction may occur over time. The second method improves alignment but does not attempt full anatomical reduction.
The study hypothesis is that both approaches result in similar wrist alignment and functional outcomes after completion of treatment. The objective of this study is to determine whether reduction under local anesthesia followed by traction provides any advantage over traction alone in patients with distal radius fractures.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Tyrol
-
Innsbruck、Tyrol、奥地利、6020
- Univ.-Klinik für Orthopädie und Traumatologie
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
Dorsally tilted distal radius fracture (DRF) > 10° (intra-articular or extra-articular) Dorsal comminution of the distal radius fracture
Fracture classification (AO), dorsally displaced:
- A2
- A3
- C1
- C2
- C3
Exclusion Criteria:
- Age under 18 years
- Non-displaced fractures of the radius
- Previous palmar displaced fractures of the radius
- Displacement greater than one shaft width
- Open fractures of the radius
- Bilateral radius fractures
- History of a previous radius fracture
- Inability to provide informed consent due to physical or mental disability
- Unavailability for follow-up examinations (e.g., abroad, polytrauma)
- Lack of full legal capacity
- Alcohol or drug abuse
- Allergy to local anesthetics
- Median nerve irritation
- Pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：R: Manual Reduction
|
Hematoma block 5 mL 2% lidocaine, followed by 15 minutes finger-trap traction and then manual reduction + cast application
|
|
实验性的：A: Finger-trap traction
|
15 minutes finger-trap traction only and then cast application
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain difference between the groups
大体时间：From enrollment (Baseline) to the 12month Follow Up.
|
Comparison of the pain score in the course of the follow ups between the groups.
0= no pain 10 = worst pain (maximal pain)
|
From enrollment (Baseline) to the 12month Follow Up.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
MHQ Hand Score (Patient reported outcome)
大体时间：Enrollment until 12 month follow up
|
Difference in functional outcome measured with MHQ (Michigan Hand Outcome Questionaire) between the two groups.
0 points= very poor hand function / maximum impairment; 100 points → optimal hand function, no impairment.
|
Enrollment until 12 month follow up
|
|
PRWE - Patient reported outcome
大体时间：Enrollment until 12month follow up
|
Difference in functional outcome measured with PRWE (Patient-rated wrist evaluation) between the two groups.
0 points= optimal hand function, no impairment; 100 points → very poor hand function / maximum impairment.
|
Enrollment until 12month follow up
|
|
Grip strength
大体时间：12 weeks until 12mo Follow up
|
Difference in grip strength measured with dynanometer between the two groups.
Grip strength is compared to the contralateral non-injured wrist.
|
12 weeks until 12mo Follow up
|
|
Range of motion - functional outcome
大体时间：12 weeks until 12 mo follow-up
|
Difference in functional outcome (range of motion) measured with goniometer after treatment between the two groups.
Range of Motion is compared to the contraltaeral non-injured wrist.
|
12 weeks until 12 mo follow-up
|
|
Radiological outcome
大体时间：Enrollment until 12 month Follow up
|
Difference in radiological outcome between the two groups; especially, dorsal tilt, radial inclination and ulnar variance.
|
Enrollment until 12 month Follow up
|
|
Complications
大体时间：After treatment until 12 month Follow up
|
Complications between the two groups.
|
After treatment until 12 month Follow up
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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