The Effectiveness of Surgery Versus Casting for Elderly Patients With Displaced Distal Intra-Articular Radius Fractures: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- PRWE
研究概览
简要总结
Objective: to compare the functional outcome after open reduction and internal fixation with non-operative cast treatment for elderly patients with displaced intra-articular distal radius fractures.
详细描述
Rationale: there is no consensus about the optimal treatment of displaced intra-articular distal radius fractures in elderly patients. To ensure optimal functional outcome there is a tendency to operate. However, there is no evidence that supports the surgical treatment of patients aged 65 years or older and in the absence of clinical trials it stays unclear how elderly patients with intra-articular fractures should be treated.
Study design: multi-center randomized controlled trial with a non-inferiority design. Economic evaluation alongside a randomized controlled multi-center trial.
Study population: all consecutive patients aged between 65 years and older with displaced intra-articular (AO Type C) distal radius fractures, with a not acceptable reduction within 3 weeks following trauma.
Intervention: patients will be randomized between open reduction and internal fixation (intervention group) and plaster immobilization (control group).
Main study parameters: the primary outcome will be evaluated after 1 year with the Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes comprise other patient reported outcome measures (PROM) including the Disability of the Arm, Shoulder and Hand (DASH), Quality of life (EQ-5D) and Pain Catastrophizing Scale (PCS). Further outcome measurements comprise a costs evaluation questionnaire, range of motion (ROM), grip strength, radiographic parameters and Complications.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 65 years at time of trauma
- •Intra-articular distal radius fracture (AO type C*)
- •One or more of the following fracture characteristics within 3 weeks post-trauma (including secondary dislocation):
- •≤15° inclination <5 mm radial length >15° dorsal tilt >20° volar tilt intra-articular gap or step-off >2 mm
- •< 3 weeks post trauma
- •Living independent
- •Fit for surgery
- •Mentally competent
- •Dutch fluency and literacy
- •Informed consent
排除标准
- •Open fractures
- •Neurovascular damage
- •Multiple-trauma patients (ISS >16)
- •Other fractures in the injured extremity other than ulnar styloid process fractures
研究组 & 干预措施
Plaster immobilization
Standard local hospital protocol for cast treatment
干预措施: Cast treatment (Procedure)
Open reduction internal fixation
Surgical open reduction internal fixation (ORIF)
干预措施: Surgery (Open Reduction Internal Fixation) (Procedure)
结局指标
主要结局
PRWE
时间窗: 12 months
Patient-Rated Wrist Evaluation score
次要结局
- DASH(12 months)
- EQ/5D(12 months)
- PCS(12 months)