NCT00863473已完成2 期
Health and Cost Consequenses of Surgical Versus Conservative Treatment for a Comminuted Humerus Fracture. Do Interlocking Plate Surgery Benefit Displaced Proximal Humerus Fractures? A Randomized Clinical Trial
University Hospital, Aker2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2003年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender).
研究概览
简要总结
- Do a standardized surgical treatment of unstable displaced proximal humerus fracture in patients aged over 60 compared to a standardized conservative treatment gain a better functional outcome after one year?
- Do surgical treatment gain more QALY than conservative treatment after one year?
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
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •proximal humerus fracture of AO group B2 or C2 (displaced fracture of extra-articular or articular, bifocal type) admitted in hospital
排除标准
- •aged less than 60 year
- •patients of non-Scandinavian ethnicity
- •previous history of injury or illness of the injured or contralateral shoulder
- •injury of other part of the humerus or the contralateral upper extremity,
- •alcohol- or drug abuse
- •dementia or neurological diseases
- •severe cardiovascular disease that would contraindicate surgery
结局指标
主要结局
Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender).
时间窗: 12 and 24 months
次要结局
- Radiographic score(12 and 24 months)
- QALY (HRQoL score according to Harri Sintonen 15D and Costs)(12 and 24 months)
- ASES score (modified self assessment) C) Radiographic score(12 and 24 months)
研究者
Tore Fjalestad
MD PhD Consultant
Oslo University Hospital
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Surgical Fixation and Non-Operative Management Outcomes in Proximal Humerus FracturesProximal Humeral FractureNCT04786639Istanbul University - Cerrahpasa (IUC)40
终止
不适用
Proximal Humeral Comminuted Fractures in the Elderly - PERCELE TrialHumeral FractureNCT00999193University of Helsinki60
已完成
不适用
Does Surgical-approach Affect Outcome After Fixation of Intra-articular Fractures of Distal Humerus?Distal Humerus FractureNCT03833414Aga Khan University43
招募中
不适用
Two- Part Proximal Humerus - Conservative vs OperativeProximal Humerus Fracture2 Part FractureNCT04106674University Hospital, Akershus50
进行中（未招募）
不适用
Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled TrialFractureNCT01719887Töölö Hospital82