Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures. A RCT
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score)
研究概览
简要总结
The purpose of the project is to compare the management of 3 and 4 part proximal humerus fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail (Multiloc) in light of complications, radiological, economical, functional and clinical outcome.
详细描述
Randomized controlled trial (RCT) from Akershus University Hospital in Norway. Randomization between two implants. The investigators will use deltopectoral or deltoid split as surgical access. All patients will have calcar screws and cuff sutures. When lack of bone for example after decompressing valgus compressed fractures, a bone-substitute might be used in the surgeons preference. Follow up in outpatient clinic at 6, 12, 52 and 104 weeks, but also a 5 year follow up is planned. Postoperative radiographs of both shoulders and CT of operated shoulder will be taken.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years
- •Severe displacement, defined as malposition of at least 45⁰ of angular deviation in valgus or 30⁰ in varus in true frontal projection, regardless of whether the fracture is impacted or not. Fractures with more than 50% displacement of the head against the surgical neck
- •The greater or lesser tubercles must be fractured in a 3 or 4-part fracture. The degree of displacement is not critical for inclusion.
排除标准
- •Exclusion criteria:
- •Fracture more than 3 weeks' old
- •Caput humeri just a thin shell or split
- •Ipsilateral damage that will influence the recovery and scoring systems
- •Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity.
- •Pathological fracture
- •Neurovascular injury
- •Open fracture
- •Noncompliance
- •Congenital anomaly
- •Ongoing infectious process around the incision site for plate osteosynthesis
- •Systemic disease that may influence healing processes or scoring systems (RA/MS)
- •Fracture dislocation
- •Substance abuse
- •Inability to read and understand Norwegian
- •Patients not residing in our catchment area
- •Patients with too small humerus diameter to use a nail
- •Patient not able to commit and understand written consent
结局指标
主要结局
The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score)
时间窗: 5 years
Quick Dash (questionnaire) the first 6 weeks after surgery, then DASH score (questionnaire for patients to fill out) in follow ups
次要结局
- Constant score (questionnaire)(5years)
- Complications(5 years)
- Radiological complications(5 years)
- Health economy(5 years)
研究者
Asbjorn Aroen
Professor
University Hospital, Akershus