Functional Outcome in Midshaft Clavicle Fracture Patients, Treated With Superior Versus Anteroinferior Reconstruction Plate. Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Disabilities of Arm Shoulder and Hand score (DASH)
研究概览
简要总结
The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques. the first one was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle. the patients had the same rehabilitation program and evaluated with functional scores at 30, 60, 90 and 365 days after surgery. biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.
详细描述
The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques.
the first technique was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle.
the patients had the same rehabilitation program and evaluated with Disabilities Arm Shoulder and Hand functional outcome score and Visual Analogue Score for pain at 30, 60, 90 and 365 days after surgery.
biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.
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)
盲法说明
the patient and the outcomes analyzer were masked
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •traumatic fracture
- •ao 15 b1 and 15 b2
- •no previous shoulder lesions
- •no further 7 days fractures
- •closed fracture
排除标准
- •calcium diseases
- •Previous shoulder pain
- •other fractures associated
研究组 & 干预措施
superior group
this group with midshaft clavicle fracture were treated with superior reconstruction plate
干预措施: Open Reduction Internal Fixation superior plate (Procedure)
anteroinferior group
this group with midshaft clavicle fracture were treated with anteroinferior reconstruction plate
干预措施: Open Reduction Internal Fixation anteroinferior plate (Procedure)
结局指标
主要结局
Disabilities of Arm Shoulder and Hand score (DASH)
时间窗: 365 days after surgery
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
次要结局
- Visual Analogue Scale score (VAS)(365 days after surgery)
研究者
Jose Antonio Manrique
Principal Investigator
UMAE Hospital de Traumatologia y Ortopedia de Puebla