Does Anterior-Inferior Clavicle Plating Have a Lower Rate of Soft Tissue Irritation Compared to Superior Plating? A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Less irritation with anterior-inferior plating and less need for hardware removal.
研究概览
简要总结
The anterior-inferior clavicle plate position will have a lower rate of soft tissue irritation that limits activity and/or requires hardware removal compared to superior plate position.
详细描述
Compare the rates of soft-tissue irritation with two different methods of plating for clavicle fractures. Patients will be randomized to anterior-inferior or superior plating. Validated shoulder scoring systems will be used to assess outcome. Specific follow-up questions will address the patient's ability to wear his/her uniform, body armor, ruck sack, and other shoulder-borne equipment over the surgical site.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active duty, Reservists, National Guard service members
- •completely displaced shaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments)
- •a fracture involving the middle third of the clavicle (a fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment)
- •chronic nonunion and malunion fractures
- •no medical contraindications to general anesthesia
- •provided informed consent.
排除标准
- •an age of less than eighteen years or greater than sixty five years
- •a fracture in the proximal or distal third of the clavicle not amenable to plating
- •a pathological fracture
- •an associated head injury (a Glasgow Coma Scale score of <15 at 21 days after injury)
- •an inability to comply with followup
- •a medical contraindication to surgery and/or anesthesia (such as heart disease, renal failure, or active chemotherapy)
- •a lack of consent.
研究组 & 干预措施
superior plate
Clavicle plate on the superior surface of the bone
干预措施: superior plate (Procedure)
anterior inferior plate
plate placed on anterior inferior surface of bone
干预措施: anterior-inferior plate (Procedure)
结局指标
主要结局
Less irritation with anterior-inferior plating and less need for hardware removal.
时间窗: 2 years
次要结局
- DASH (Disability of Arm, Shoulder and Hand) and constant scores(2 years)