An International, Prospective, Randomized, Multicenter, Controlled Head-to-Head Comparison of Conservative, Plate Fixation and Prosthesis in Treatment of Displaced 2, 3, and 4 Part Fractures of Proximal Humerus of 60 Years and Older Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 8
- 主要终点
- DASH
研究概览
简要总结
This trial is designed to compare head-to-head conservative with operative treatment in 2 stratum. Stratum 1: In 2 part fractures the comparison is between conservative treatment and operative treatment with plate fixation with Philos. Stratum 2: In multi-fragmented fractures (MFF) meaning 3 and 4 part fractures, the comparison is between conservative treatment, operative treatment with Philos plate and operative treatment with Epoca prosthesis. Subgroup analysis will be performed in an effort to obtain limit values for specific treatment of different age and fracture groups. A cost-effectiveness analysis and comparison between different treatment modalities will be carried out. The primary outcome measure will be the DASH score and the secondary outcome measure the EQ-5D value. Recruitment period is 3 years and follow-up 2 years.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low energy proximal humeral displaced (more than 1 cm or 45 degrees) 2 part fracture where fracture line emerges through the surgical (or anatomical) neck
- •Low energy proximal humeral displaced (more than 1 cm or 45 degrees) 3 or 4 part fracture
排除标准
- •Refuse to participate the study
- •Less than 60 years old
- •Non-independent
- •Dementia and/or institutionalized
- •Does no understand written and spoken guidance in either Finnish or Swedish
- •Pathological fracture or previous fracture in the same proximal humerus
- •Serious intoxicant dependent, eg. In first aid breathalyzer shows more than 2‰
- •Other operational injury in the same upper limb
- •Major nerve injury (eg. Complete radialis- or delta palsy)
- •Open fracture
- •Multi-trauma or -fractured patient
- •Fracture dislocation or head splitting fracture
- •Undisplaced fracture
- •Isolated tuberculum fracture
- •Fracture has no precondition to ossify by conservative treatment (no bony contact between fracture parts or the humeral shaft is in contact with the articular surface)
- •Treating surgeon considers patient unsuitable to attend the study on medical basis
- •Cuff-arthropathy
结局指标
主要结局
DASH
时间窗: 2 year
to measure physical function and symptoms of the fractured shoulder
次要结局
- EQ-5D(2 year)
研究者
Antti Launonen
MD
Tampere University Hospital