Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Elbow ROM at 12 Months
研究概览
简要总结
The purpose of this study is to help determine if a static stretching brace in addition to physical therapy decreases the incidence of secondary operations, increases range of motion, and individual patient function.
详细描述
Fractures and dislocations about the elbow are high energy injuries which are often comminuted and associated with extensive soft tissue damage and are very difficult to treat. The most problematic complication for these fractures is the potential development of a cosmetic defect and functional disability due to the loss of 20 degrees to 30 degrees of terminal extension of the elbow. It has been found imperative that early motion and physical therapy be implemented to help produce the best results in terms of a patient's range of motion and decreases secondary surgeries.
We intend to examine a group of patients with distal humerus and elbow fracture/dislocations who use static stretching braces along with physical therapy (PT) within 3 weeks after surgery, in contrast to physical therapy treatment alone after surgery. The static stretching brace group will have a small electronic circuit attached to the brace that will record patient's usage.
Improvement of patient's overall functional outcome will also be measured by a standard functional outcome instrument, the Disabilities of Arm, Shoulder and Hand (DASH) form. The DASH Form is a standard functional outcome instrument specific to upper extremity injuries. In addition, a more general measure, the Visual Analog Scale (VAS), will be used to assess pain.
The use of the static motion brace may help eliminate the necessity of additional treatments, saving both pain and suffering, as well as monetary costs for the patient, while simultaneously producing a better long term functional and cosmetic outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •18 years of age or older
- •Extra or intraarticular distal humerus or elbow fracture or fracture/dislocation
- •Agrees to participate and signs informed consent
- •English Speaking (outcome questionnaires are validated for English only)
排除标准
- •Less than 18 years of age
- •Closed Head Injury
- •Burn Injuries
- •Ipsilateral upper extremity fracture(s) requiring surgery
- •Nonunion of prior distal humerus fracture or fracture dislocation
- •Type 3 open distal humerus fracture dislocation
- •Insufficient fracture fixation to allow early range of motion
- •Transient population with no fixed address
- •Not willing to sign informed consent
- •Does not speak English
研究组 & 干预措施
Joint Active Systems Brace (JAS Brace)
Elbow is placed in a brace to apply an extension force
干预措施: JAS Brace (Device)
PT Only Group
No brace is used
结局指标
主要结局
Elbow ROM at 12 Months
时间窗: 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively
The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.
次要结局
- Disabilities of the Arm, Shoulder and Hand (DASH) Score(12 months post-operatively)
研究者
William Obremskey
Associate Professor
Vanderbilt University
