Conservative Versus Operative Treatment of Two - Part Proximal Humerus Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Quick Dash
研究概览
简要总结
The proximal humerus fracture (PHFs) is the third most common fracture type in the elderly, and represents 5% of the overall fractures. The incidence is increasing. The purpose of the project is to compare surgical and conservative management of two- part PHFs in light of radiological, economical and clinical outcome. Do the participants between 60 and 85 years of age with displaced two-part PHFs fare better or worse after surgery compared to non-operative treatment?
详细描述
The study-design is a single center single blinded randomized controlled trial (RCT) with 2 arms. Patients admitted to Akershus University Hospital (Ahus) with a displaced two-part proximal humeral fracture of OTA/ AO group 11A2 or 11A3 in need of surgical treatment will be randomly allocated to two groups; conservative/ non-operative treatment or open reduction and internal fixation (ORIF).
All following aims evaluated at controls at 6, 12, 26 and 52 weeks. The 6 months and 1 year controls will additionally be conducted by independent physiotherapists. The other controls are conducted by the treating surgeons. The physiotherapists will be blinded of chosen treatment, the patients wearing a t-shirt covering the shoulder at the consultations, hence single blinded RCT.
Primary aim: Functional outcome as evaluated by the Quick DASH (Disability of the arm, shoulder and hand) score at controls.
Preoperative evaluation:
The project participants will supervise and evaluate the data. General history, including; mechanism of injury, occupation, pre-existing medical conditions and medication, smoking history, American Society of Anesthesiologists Classification (ASA classification), BMI, hand dominance. At inclusion, the patient will be asked to fill out quick-Dash, Visual Analog scale (VAS), EQ-5D to determine the baseline-characteristics.
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)
盲法说明
The physiotherapists conducting outcomes at 6 months and 1 year do not know if patients are treated with surgery or not. Patients are instructed to wear t-shirt and not talk about treatment.
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
- 是
入选标准
- •The study-design is a single center single blinded randomized controlled trial (RCT) with 3 arms. Patients admitted to Akershus University Hospital with a displaced 2-part proximal humeral fracture of OTA/ AO group 11A2 or 11A3 in need of surgical treatment will be randomly allocated to two groups; conservative/ non-operative treatment or open reduction and internal fixation (ORIF). The patients allocated to ORIF will be randomly allocated to either the Philos plate (Synthes) or the Multiloc nail (Synthes).
- •Inclusion criteria
- •Patients > 60 years and <85 years
- •More than 50% displacement between head or shaft or 50⁰ angulation of the head against the shaft in Y-projection or more than 45 ˚ valgus or more than 30˚ varus of the Head Shaft Angle (HSA).
- •Patient with tuberculum majus or minor fractures which displaced <5mm can be included as long as points 1 and 2 above are fulfilled.
排除标准
- •Refusal to participate in the study
- •Fracture more than 3 weeks old
- •No contact btw head and shaft
- •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. This is up to the treating surgeon to decide
- •Pathological fracture or previous fracture of the same proximal humerus
- •Multitrauma or "multifractured patient"
- •Neurovascular injury
- •Open fracture
- •Noncompliance, dementia and/ or institutionalized
- •Congenital anomaly
- •Ongoing infectious process around the incision site for osteosynthesis
- •Systemic disease that may influence healing processes or scoring systems (in example Rheumatoid arthritis/Multiple sclerosis/ poorly controlled DM)
- •Fracture dislocation
- •Substance abuse
- •Inability to read and understand Norwegian
- •Patients not residing in our catchment area
- •Patients with a diameter of the humerus to small for nailing, will be allocated to the Philos-group.
- •Any medical condition that excludes surgical treatment, including patients with ASA 3 or 4 that are considered too ill to go through surgery.
结局指标
主要结局
Quick Dash
时间窗: 1 year
Prom, The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (four items, scored 1-5). This is a 100-points scale where 0 is perfect/ best and 100 is the worst possible outcome
次要结局
- Number of patients with complications such as infection, Avascular necrosis, failure of osteosynthesis, screw cut out, nerve damage, deep vein thrombosis,(1 year)
- EQ5D(1 year)
- Radiology(1 year)
- Constant-Murley score(1 year)
- Visual Analog scale (VAS score)(1 year)
研究者
Hendrik Frolich Fuglesang
Consultant, Head of orthopedic trauma unit
University Hospital, Akershus