Operative Treatment of Intra-Articular Distal Radius Fractures With Versus Without Wrist Arthroscopy, 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
- 50
- 试验地点
- 2
- 主要终点
- Patient Rated Wrist Evaluation
研究概览
简要总结
Open reduction and internal fixation of intra-articular distal radius fractures leads to better functional outcomes the first 6 months compared to non-operative treatment. However, some patients continue to have a painful and stiff wrist post-operatively. Arthroscopically assisted removal of intra- articular fracture haematoma and debris may reduce pain and improve the functional outcomes following operative treatment of intra-articular distal radius fractures. Moreover, during arthroscopy the quality of the reduction and the presence of associated ligamentous injuries can be assessed. Therefore the objective of this study is to compare the functional outcome of internal plate fixation with additional wrist arthroscopy versus conventional fluoroscopic assisted internal plate fixation in adult patients with displaced intra-articular distal radius fractures.
详细描述
Distal radius fractures account for 17% of all fractures seen at the emergency department. Fifty percent of these fractures are intra-articular. The past several years an increase in open reposition internal fixation (ORIF) for distal radius fractures has been observed. This technique leads to a quicker resume of function the first 3 to 6 months compared to non-operative treatment. However, some patients continue to have a painful and stiff wrist postoperatively. Arthroscopically assisted removal of intra-articular fracture haematoma and debris may improve the functional outcomes following operative treatment of intra-articular distal radius fractures. Moreover, during arthroscopy the quality of the reduction and the presence of associated ligamentous injuries can be assessed.
To our knowledge, no studies have been carried out to further examine the use of arthroscopy after internal plate fixation to remove fracture haematoma and debris on functional outcomes. Therefore, the purpose of this randomised controlled trial is to determine the difference in functional outcome, assessed with the Patient-Rated Wrist Evaluation (PRWE) score, after internal plate fixation with an additional wrist arthroscopy and conventional fluoroscopically assisted internal plate fixation in adult patients with displaced complete articular distal radius fractures. Secondary, we aim to determine the difference in functional outcomes with the Disability of the Arm, Shoulder and Hand (DASH) score, post-operative pain, range of motion, grip strength, complications, quality of life (SF-36), and cost-effectiveness. Additionally, for patients undergoing additional wrist arthroscopy the quality of reduction, associated ligamentous injuries and cartilage damage will be assessed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients ≥18 years
- •Displaced intra-articular distal radius fracture (AO/OTA type C) as classified on lateral, posterior anterior and lateral carporadial radiographs by a radiologist or trauma surgeon
- •Inacceptable closed reduction requiring open reduction and internal fixation
排除标准
- •Dorsal plate fixation in case the radiocarpal joint needs to be opened
- •Patients with impaired wrist function prior to injury due to arthrosis/neurological disorders of the upper limb
- •Open distal radius fractures
- •Multiple trauma patients (Injury Severity Score (ISS) ≥16)
- •Other fractures of the affected extremity (except from ulnar styloid process)
- •Fracture of other wrist
- •Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information as judged by the attending physician
- •Patient suffering from disorders of bone metabolism other than osteoporosis (i.e. Paget's disease, renal osteodystrophy, osteomalacia)
- •Patients suffering from connective tissue disease or (joint) hyperflexibility disorders such as Marfan's, Ehler Danlos or other related disorders
结局指标
主要结局
Patient Rated Wrist Evaluation
时间窗: 3 months
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of three subscales: Pain, Function and Cosmetics.
次要结局
- Range of motion(3 and 6 weeks and 3 months)
- Complications(1 day post-operative and 1, 3 and 6 weeks and 3 months)
- Disability of the Arm, Shoulder and Hand Disability of the Arm, Shoulder and Hand(3 and 6 weeks, and 3, 6 and 12 months)
- Pain(1 day post-operative and 1, 3 and 6 weeks and 3 months)
- Cost-effectiveness(3 and 6 weeks and 3 months)
- Patient Rated Wrist Evaluation(3 and 6 weeks, and 6 and 12 months)
- Associated injuries(Peroperative)
- Grip strength(3 and 6 weeks and 3 months)
研究者
Niels Schep
MD, PhD
Maasstad Hospital