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临床试验/NCT00580866
NCT00580866终止不适用

Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2006年9月1日最近更新:
适应症
干预措施

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)

Experimental

Elbow is placed in a brace to apply an extension force

干预措施: JAS Brace (Device)

PT Only Group

No Intervention

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Obremskey

Associate Professor

Vanderbilt University

研究点 (1)

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