Effectiveness of Immobilization in the Postoperative Analgesia of Patients With Distal Radius Fracture Treated With Volar Locking Plating: a Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Level of pain
研究概览
简要总结
The purpose of this study is to determine wether postoperative immobilization is effective in controlling the pain of patients with intra-articular distal radius fractures treated with volar locking plate fixation. The study hypotheses is that postoperative immobilization does not enhance the analgesia of these patients.
详细描述
Volar locking plate fixation has been used as the gold standard treatment for intra-articular distal radius fractures. The need for postoperative immobilization after this type of fixation is controversial, with some authors advocating its use for analgesia. Conversely, the use of immobilization might retard the recovery of wrist range of motion and function. The objective of this study is to compare the level of pain and function of patients undergoing surgical fixation of distal radius fractures using or not postoperative immobilization. Patients will be randomly assigned to receive a plaster splint or conventional dressing immediately after the surgery. The main outcome is the level of pain in the first two weeks postoperatively.
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
- Single (Outcomes Assessor)
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
- •Intra-articular distal radius fracture treated with volar locking plate fixation;
- •Fracture occurred within the prior 30 days;
- •Consent to participate in the study
排除标准
- •Concomitant fracture of the ipsilateral upper limb
- •Previous lesion of the ipsilateral upper limb with functional deficit
- •Bilateral fracture
- •Concomitant neurologic injury
- •Patient not amenable to follow-up
研究组 & 干预措施
No immobilization
Patients receive a conventional dressing made with gauze, cotton padding and inelastic bandage after the surgery. They are instructed to start light wrist movements on the first postoperative day and progress as tolerated, beginning rehabilitation with physiotherapy after 2 weeks postoperatively.
干预措施: No immobilization (Procedure)
Volar splint
Patients receive a volar plaster splint with inelastic bandage after the surgery, and are instructed not to remove the immobilization for 2 weeks. After this period, the immobilization is removed and patients begin rehabilitation with physiotherapy.
干预措施: Volar splint (Procedure)
结局指标
主要结局
Level of pain
时间窗: 2 weeks
Visual analogue scale for pain
次要结局
- Level of pain(6 months)
- DASH score(6 months)
- Wrist flexion-extension arc(6 months)
- Forearm rotation arc(6 months)
- Tramadol use(Once a day in the first week post-op)
- Complication(up to 24 weeks)
研究者
Fernando B Andrade-Silva, MD
Principal Investigator
University of Sao Paulo