Non-operative Treatment Versus Surgery With Volar Locking Plate in Treatment of Distal Radius Fracture in 65-year-old and Older Patients - a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 6
- 主要终点
- Change over time in Patient Rated Wrist Evaluation (PRWE)
研究概览
简要总结
The present collaboration study on the treatment of distal radius fractures is aimed to:
(i) to compare non-operative treatment to volar plating in the treatment of initially malaligned distal radius fractures in patients aged 65 and older in terms of functional outcome measured with PRWE
(ii) to compare non-operative treatment to volar plating in the treatment of distal radius fractures with early instability during follow-up, i.e., loss of reduction at 1 week (range 5 to 10 days) in patients aged 65 and older in terms of functional outcome measured with PRWE
(iii)to compare pain, disability, quality of life, grip strength, and the number of complications after non-operative treatment and the initial and delayed operative treatment of distal radius fracture
(iv) to assess the effect of pain catastrophizing score (PCS) on the functional outcome of non-operatively and operatively treated distal radius fracture
(v) to assess the association between physical activity and the number of wrist movements measured with Axivity accelerometer and functional outcome measured with PROMs of non-operatively and operatively treated distal radius fractures
(vi) to assess the effect of initial as well as the final radiological parameters on the functional outcome
(vii) to assess the correlation of probability of radiological malalignment estimated by clinical prediction rule (EWC) with functional outcome measured with PRWE and PASS
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
- Triple (Participant, Investigator, 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
- •low energy intra or extra-articular dorsally displaced distal radius fracture within 3 cm of the radiocarpal joint, diagnosed with lateral and posterior-anterior radiographs in ER
- •>10° dorsal tilt and/or over 2 mm step-off and/or over 3 mm shortening in the radiograph
排除标准
- •Refuse to participate the study
- •Open fracture more than Gustilo 1 gradus
- •Age under 65 years
- •Chauffeure's or Barton´s fracture
- •Smith´s fracture (volar angulation of the fracture)
- •Does not understand written and spoken guidance in local languages
- •Pathological fracture or previous fracture in the same wrist or forearm
结局指标
主要结局
Change over time in Patient Rated Wrist Evaluation (PRWE)
时间窗: 3 months, 1 year, 2 years
PRWE is the primary outcome measure of wrist pain and disability in the study. The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists three subscales: Pain, Function and Cosmetics.
次要结局
- Frailty(Baseline)
- EWC(Baseline)
- Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire(3 months, 1 year, 2 years)
- Quality of life measured with the 15-D(Baseline, 3 months, 1 year, 2 years)
- Pain measured in Visual Analogue Scale (VAS)(3 months, 1 year, 2 years)
- Pain catastrophizing measured with the pain catastrophizing scale (PCS)(baseline, 3 months, 1 year, 2 years)
- Grip strength measured with a dynamometer(3 months, 1 year)
- Physical activity measured with Axivity accelerometer(3 months, 1 year)
- Self-assessment(Baseline, 1 year, 2 years)
研究者
Antti Launonen
MD, PhD
Tampere University Hospital