Efficacy of Intra-Articular Corticosteroid Injections on Clinical Outcomes in Patients With Operative Distal Radius Fractures: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 主要终点
- Patient-Rated Wrist Evaluation Score
研究概览
简要总结
The randomized controlled study which compare clinical outcomes (functional score) in patients with distal radius fractures who underwent open reduction with internal fixation and received intra-articular steroid injections to those who received placebo injections.
详细描述
Randomization of Patients for Intra-articular Triamcinolone Injection
Objective: To compare the effectiveness of intra-articular Triamcinolone injection versus placebo in patients with distal radius fractures who underwent open reduction with internal fixation
Methods:
Patients: Patients with distal radius fractures who need open reduction with internal fixation procedure Randomization: Patients will be randomly assigned to one of two groups using a block randomization procedure with a block size of 4. Randomization will be performed using STATA version 16.0 software.
Interventions:
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
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •Age more than 18 years old
- •Closed unstable distal radius fracture unstable type which need surgical management
- •Received procedure ORIF with plate and screws at injured wrist
排除标准
- •History of corticosteroid allergy
- •Poor Diabetes controlled (HbA1C) > 8
- •Who need Ritonavir while enter this study
- •Unable to follow up until the end of projects
- •Unable to do questionnaires
- •Infection around injured wrist
- •Tear tendon at injured wrist
- •Open fracture of injured wrist
研究组 & 干预措施
Intraarticular triamcinolone injection
receive Intraarticular triamcinolone injection
干预措施: Triamcinolone Acetonide (Drug)
placebo group
receive Intraarticular normal saline injection
干预措施: Normal saline (Drug)
结局指标
主要结局
Patient-Rated Wrist Evaluation Score
时间窗: 12 months
(0-100) Higher scores mean poorer functional outcome
次要结局
- Visual Analog Scale:(12 months)
- Grip strength (kg)(12 months)
- ROM of wrist(12 months)
- Wrist circumference(12 months)
研究者
Teeradon Waewworawit
Doctor
Ramathibodi Hospital