The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Short Form 36 (SF36)
研究概览
简要总结
A prospective, randomized study investigating the possible benefits of immediate mobilization and frequent physiotherapy following a wrist fracture treated by volar plating.
The current study will test the following null hypothesis:
There is no significant difference between patients who receive a cast for the first 2 weeks postoperatively and then instructions in home exercises and patients who receive a cast for 2-3 days postoperatively and then have frequent sessions with a physiotherapist following volar locked plating for a extraarticular distal radius fracture, as evaluated by self-reported satisfaction after 3 months.
详细描述
The study will focus on patients treated with volar locked plating following an extraarticular distal radius fracture.
In a prospective manner the investigators intend to analyze hand function, x-ray and other parameters in order to investigate whether early mobilization and a targeted program of physiotherapy postoperatively leads to a better functional result and earlier return to a normal activity level. The investigators analysis will also focus on the safety of early mobilization with regards to possible detrimental effects on the osteosynthesis, bony union, associated soft-tissue injuries and functional outcome. The investigators also intend to assess the cost of more intensive follow-up and physiotherapy and do a cost-benefit evaluation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Position prior to primary reduction:
- •Dorsal tilt > 25°
- •Radial shortening> 6 mm
- •Radial inclination reduced by more than 15°
- •Radiocarpal malalignment > 7 mm
- •Dorsal /volar metaphyseal comminution
- •Volar displacement of the distal fragment(= Smith's fracture)
- •Position after initial reduction:
- •Dorsal tilt > 5°
- •Radial shortening > 4 mm
- •Radial inclination reduced by more than 10°
- •Radiocarpal malalignment > 4 mm
排除标准
- •Gustilo-Anderson type III open fractures
- •Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity
- •Previous distal radius fracture or other disabling injury to the contralateral side
- •Dementia or other psychiatric illness which affect compliance
- •Congenital anomaly
- •Bilateral radius fracture
- •Concurrent fractures to the upper or lower extremities or other illness which affect movement of the extremities
- •Systemic joint disease such as rheumatoid arthritis
- •Patients who do not speak Norwegian
- •Pathological fracture other than osteoporotic fracture
- •Congenital bone disease (for example osteogenesis imperfecta)
- •Age below 18 and above 70
- •Patients not belonging to Akershus University Hospital
结局指标
主要结局
Short Form 36 (SF36)
时间窗: 2 years
The SF-36 score is a quality of life measure and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone
Short version of "Disabilities of the Arm, Shoulder and Hand" (Quick-DASH)
时间窗: 2 years
The Quick-DASH score is a measure of patient reported satisfaction score and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone.
次要结局
- Radiological findings (X-ray)(2 years)
- Cost analysis(2 years)
- Patient Rated Wrist Evaluation (PRWE)(2 years)
- Euro-Qol 5 dimension score (EQ-5d)(2 years)
- Range of motion (ROM)(2 yars)
- Pain Scores on the Visual Analog Scale (VAS)(2 years)
研究者
Ola-Lars Hammer
PhD-student
University Hospital, Akershus