Clinical Outcome After Repair of the Pronator Quadratus Muscle in Volar Locked Plating of the Distal Radius. A Randomised Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Patient Rated Wrist Evaluation (PRWE)
研究概览
简要总结
The purpose of this study is to determine the functional outcome of repairing the pronator quadratus (PQ) muscle in subjects operated for a distal radius fracture (DRF) with volar locked plating.
详细描述
Fractures of the distal radius are common in the elderly. A frequent treatment of an unstable DRF is surgery with volar plating using the modified Henry's approach. In some cases the fracture mechanism has injured the PQ muscle and subsequent reconstruction of the muscle can be difficult. When the PQ muscle is not injured the plate is fixated through a radial and distal release of the PQ muscle and resuture/repair of the PQ muscle is attempted by most surgeons.
The clinical relevance of repairing the PQ muscle has not previously been investigated in a randomised clinical trial and we hypothesise that there is no difference in functional outcome whether the PQ muscle is repaired or not.
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, Investigator, 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
- •patients over 18 years.
- •patients with an unstable DRF AO type 23 A2, A3, C1, C2 or C3 elected for surgery with volar plating. Unstable is defined as one of the following: 1) More than 10 degrees dorsal angulation of radius' joint surface in lateral plane measured from an orthogonal axis through radius. 2) Ulnar variance more than 2 mm. 3) Fracture line involving joint surface with more than 2 mm dislocation. 4) Incongruence of the DRJ.
- •patients that can undergo the surgery in plexus brachialis block (so the operation can be performed in the outpatient department).
- •patients with the ability to read and understand Danish.
排除标准
- •patients with an open fracture.
- •patients with a neurologic disorder affecting the fractured upper extremity.
- •patients with a history of fracture to the same wrist.
- •patients with dementia, substance abuse or severe psychiatric disorder.
- •patients who do not agree to be randomised.
- •patients unable to continue follow-up.
研究组 & 干预措施
Repair
Repair of the pronator quadratus muscle
干预措施: Repair (Procedure)
Non-repair
Non-repair of the pronator quadratus muscle
干预措施: Non-repair (Procedure)
结局指标
主要结局
Patient Rated Wrist Evaluation (PRWE)
时间窗: 12 months
次要结局
- Patient Rated Wrist Evaluation (PRWE)(2 weeks, 5 weeks, 3 months, 6 months)
- Complications (Tendon rupture and Tendinitis)(2 weeks, 5 weeks, 3 months, 6 months, 12 months)
- Pronation strength(5 weeks, 3 months, 6 months, 12 months)
- Grip strength(5 weeks, 3 months, 6 months, 12 months)
- Operation time(day 0)
- Disabilities of the Arm, Shoulder and Hand (DASH)(2 weeks, 5 weeks, 3 months, 6 months, 12 months)
- Range of motion: supination/pronation(2 weeks, 5 weeks, 3 months, 6 months, 12 months)
- Ultra sonic examination (Examination of tendons and PQ muscle)(3 months)
研究者
Jesper Sonntag
MD
Nordsjaellands Hospital