Are Pegs Better Than Screw for Osteofixation of Proximal Humeral Fractures?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Screw penetration into glenohumeral joint
研究概览
简要总结
Patients treated operative for Proximal humeral fractures with angular stable device (Philos plate or ALPS-PHP)
详细描述
From a cohort of patients treated for displaced Proximal humeral fractures (PHF) in the period July 2017 - August 2019 patients with the 11-B2 and 11-C2 PHF according to AO/OTA 2007 fracture classification were selected according to age and gender to be compared with patients operated with a Philos plate within the same fracture group, age and gender to be matched for adverse events:
- Radiographic evidence of penetration of pegs (ALPS-PHP) or screws (Philos) into the glenohumeral joint (primary outcome) and
- Avascular head necrosis / sinking / need of re-surgery
- Clinical PROMS
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Not eligible to surgical treatment
- •Non-compliant
- •Former shoulder fracture or symptomatic shoulder illness
- •Drug abuser
结局指标
主要结局
Screw penetration into glenohumeral joint
时间窗: 12 months
Radiographic or CT verified screw penetration
Peg penetration into glenohumeral joint
时间窗: 12 months
Radiographic or CT verified peg penetration
次要结局
- Shoulder function(12 months)
- Humeral head deformation(12 months)
- Self reported shoulder function(12 months)
- Quality of life(12 months)
研究者
Tore Fjalestad
MD. PhD. Senior Consultant Ortophaedic Surgeon
Oslo University Hospital