Unterschied Der Reposition in Bruchspaltanästhesie Zur Reposition im Aushang Bei Einer Distalen Radiusfraktur - Eine Prospektiv Randomisierte Studie
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Pain difference between the groups
研究概览
简要总结
Participants with distal radius fractures treated conservatively with cast immobilization are assigned to one of two approaches: (1) closed reduction under local anesthesia (hematoma block) followed by traction and casting, or (2) traction and casting without formal reduction. While reduction aims to restore anatomical alignment, loss of reduction may occur during follow-up. The study evaluates whether reduction under local anesthesia provides any benefit over traction alone. The hypothesis is that both treatments result in comparable radiographic alignment and functional outcomes at the end of treatment.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Dorsally tilted distal radius fracture (DRF) > 10° (intra-articular or extra-articular) Dorsal comminution of the distal radius fracture
- •Fracture classification (AO), dorsally displaced:
排除标准
- •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
研究组 & 干预措施
R: Manual Reduction
干预措施: Manual reduction (Procedure)
A: Finger-trap traction
干预措施: Finger-trap traction (Procedure)
结局指标
主要结局
Pain difference between the groups
时间窗: 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)
次要结局
- MHQ Hand Score (Patient reported outcome)(Enrollment until 12 month follow up)
- PRWE - Patient reported outcome(Enrollment until 12month follow up)
- Grip strength(12 weeks until 12mo Follow up)
- Range of motion - functional outcome(12 weeks until 12 mo follow-up)
- Radiological outcome(Enrollment until 12 month Follow up)
- Complications(After treatment until 12 month Follow up)