Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar Locking Plate for Close Fractures of Distal End Radius Under WALANT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Pain Visual analogue scale
研究概览
简要总结
The goal of this clinical trial is to compare the Minimally Invasive Plate Osteosynthesis (MIPO) approach with conventional methods in volar locking plate treatment for distal end radius fractures under the Wide Awake Local Anesthesia No Tourniquet (WALANT) technique. The main question it aims to answer is: Does the MIPO approach provide better pain control than the conventional approach of volar locking plate fixation in distal radius fractures under WALANT? Participants will be requested to record their pain on the Visual Analog Scale (VAS), assess their functional scores, and undergo postoperative radiographic evaluations. Researchers will compare the MIPO group and the conventional group to determine the postoperative pain VAS scores, shedding light on the comparative effectiveness of the two approaches.
详细描述
Gap of knowledge
- No comparison of conventional Versus MIPO technique under WALANT
- No result in acute post-operative pain
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The data collector, an orthopedic resident unaware of the surgical technique used, obtained information after operation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •isolated closed fractures of the distal end radius requiring surgery
- •aged 18 years and older
排除标准
- •Patients with bone fractures lasting more than 21 days
- •open fractures
- •articular multi-fragmentary comminuted fractures of the distal radius
- •not suitable to undergo volar approach surgery
- •individuals with combined carpal fractures or dislocation
- •ulna fractures
- •associated injuries
- •a history of previous wrist surgery
- •diabetes mellitus
- •chronic wrist inflammation
- •wrist bone deformities
- •the use of anticoagulation drugs
- •uncooperative behavior
- •those refusing to participate in the research
结局指标
主要结局
Pain Visual analogue scale
时间窗: Postoperative day 0-7 and 2,6,10,14,24 weeks
pain 0-10, minimum = 0 (best) , maximum = 10 (worst)
次要结局
- Satisfy(Postoperative 24 weeks)
- skin incision(Postoperative 2 weeks)
- Grip strength(Postoperative 2,6,10,14,24 weeks)
- Pinch strength(Postoperative 2,6,10,14,24 weeks)
- Range of motion(Postoperative 2,6,10,14,24 weeks)
- ulnar variance(Postoperative 2, 24 weeks)
- operation time(Intraoperative)
- Quick Disabilities of the Arm, Shoulder and Hand(Postoperative 2,6,10,14,24 weeks)
- Aesthetics(Postoperative 24 weeks)
- Volar tile(Postoperative 2, 24 weeks)
- radial inclination(Postoperative 2, 24 weeks)
- morphine IV use(Postoperative day 0-2)
- complication(up to 24 weeks)
研究者
Suphasan Keatisuwan
Principal Investigator
Police General Hospital, Thailand