Do Patients Benefit From Elective Implant Removal Following Plate Osteosynthesis of Clavicle Fractures - a Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Shoulder function
研究概览
简要总结
Little is known about the beneficial aspects of elective implant removal following plate osteosynthesis of displaced clavicle fractures.
详细描述
Elective implant removal accounts for up to 30% of all orthopaedic surgeries. While there is general acceptance about the need of implant removal for obvious reasons, such as infections or implant failure, little is known about the beneficial aspects in cases of minor reasons. Therefore, we initiated this study to define patients' benefit of elective implant removal following plate osteosynthesis of displaced clavicle fractures.
Patients and Methods Prospective evaluation of patients was conducted before implant removal and 6 weeks postoperative. Subjective and objective criteria included patients' satisfaction, pain rating on a visual analog scale (VAS) and active range of motion (ROM) pre- and 6 weeks postoperative. Functional scoring included the SPADI, DASH score, the Constant Score and the Munich Shoulder Questionnaire (MSQ).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years
- •Radiologically consolidated clavicle fracture
- •following ORIF using a superior anatomically preformed locking plate
- •asking for elective implant removal
- •written informed consent.
排除标准
- •Pregnancy
- •Under-aged
- •Delinquent patients.
结局指标
主要结局
Shoulder function
时间窗: 6 Week post surgery
Munich Shoulder Questionnaire allowing for calculation of Constant Score (0-100), Dash (0-100)
次要结局
未报告次要终点
研究者
Dr. Chlodwig Kirchhoff
Clinical Professor
Technical University of Munich