Unstable Distal Radius Fractures in Patients Over 65 Years. Conservative Treatment With Cast Immobilization Versus Volar Locking Plate. A Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Quick disabilities of the arm, shoulder and hand; Quick-DASH
研究概览
简要总结
Eligible patients that sign an informed consent will be randomized to operation with volar locking plate or cast immobilization. Primary follow-up after 1 year.
详细描述
The investigators want to investigate if there is a difference between operative treatment with volar locking plates and cast immobilization in patient above 65 years with unstable distal radius fractures AO/OTA type A and C . Eligible patients that meets the radiological criteria (see inclusion criteria) will be randomized to cast immobilization or operation with volar locking plate.
The investigators are planning a non-inferiority design.
The current study will test the following null hypothesis:
In patients over 65 years of age with unstable distal radius fractures AO/OTA type A and C,volar locking plates are superior to cast immobilization by more than 8 points, as evaluated by quick-DASH at 12 months follow-up.
The investigators will perform a cost-effectiveness analysis comparing QALYs (Quality-adjusted life years) and costs with the two interventions the first year of follow-up.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AO/OTA class A- and C-fractures
- •Age > 65 years
- •Unacceptable primary reduction or redislocation < 20 days post-injury with at least one of the following findings:
- •dorsal angulation > 10 degrees
- •radial shortening > 3 mm
- •intraarticular step-off > 2 mm
- •Ability to sign an informed consent
- •Acute fracture, inclusion within 20 days from injury.
- •Ability to reconstruct the articular surface with a volar locking plate
排除标准
- •Volar angulated fractures and AO type B
- •Associated diseases contraindicating surgery
- •Mental impairment, nursery home patient
- •Earlier wrist injury
- •Pathological fractures
- •Open fractures (>Gustilo-Anderson I) or damaged soft tissue
- •Drug abuse
- •Concomitant injuries that might affect outcome
- •Congenital anomaly of affected extremity
- •Median nerve compression that requires acute operation
- •Foreign language
结局指标
主要结局
Quick disabilities of the arm, shoulder and hand; Quick-DASH
时间窗: 1 year
Questionnaire
次要结局
- Grip strength(3, 6 and 12 months; 2 and 5 years)
- Complications(6 weeks; 3, 6 and 12 months; 2 and 5 years)
- Patient rated wrist evaluation (PRWE)(3, 6 and 12 months; 2 and 5 years)
- X-ray, wrist(6 weeks; 3 and 12 months; 2 and 5 years)
- Over all satisfaction(6 weeks; 3, 6 and 12 months; 2 and 5 years)
- Quick DASH(3 and 6 months; 2 and 5 years)
- Range of motion(3, 6 and 12 months; 2 and 5 years)
- Registration of need for assistance in daily life(6 weeks; 3, 6 and 12 months; 2 and 5 years)
- EQ-5d (EuroQol)(6 weeks; 3, 6 and 12 months; 2 and 5 years)
研究者
Sondre Stafsne Hassellund
MD
Oslo University Hospital