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Range of Motion and Patients With Distal Radius Fractures

2011年4月6日 更新者:Mayo Clinic

The Effect of Early vs. Delayed Range of Motion in the Outcome of Patients With Distal Radius Fractures

Hypothesis : Early active range of motion protocol after open reduction and internal fixation of a distal radius fracture with a volar fixed angle locking plate results in earlier return of functional motion, earlier return to work and improved functional outcomes compared delayed mobilization.

Specific Aim:

To compare early range of motion versus delayed motion protocol in distal radius fractures treated with open reduction and internal fixation with a volar fixed angle locking plate with respect to time to fracture union, range of motion, functional outcome measures, return to work and complications.

研究概览

详细说明

You are scheduled for surgery of your broken wrist. Treatment of broken bones of the wrist, such as distal radius fractures, may require different types of treatment. For this study this type of fracture will be treated by surgery to place a plate with screws to the broken bone and then a plaster splint will be applied. After surgery, physical therapy will be started. Following surgery you will be assigned to one of four groups by the type of wrist fracture (broken bone) you have. Each person will by chance (the flip of a coin) be put in either the Early or Delayed Range of Motion groups. Those in the Early Range of Motion groups will begin exercises for motion starting 7 days after surgery. Those in the Delayed Range of Motion, will begin exercises for motion starting about five weeks after surgery. Once you begin the exercises to help you get back normal use of your wrist, you will have measurements of how much motion and strength you have in the wrist and hand that was fractured. The measurements will take about five minutes to complete. All participants will have an x-ray of the wrist at 2, & 6 weeks following surgery and if needed at other appointments. At each appointment you will be asked to fill out four questionnaires, asking about pain and how you are getting along with the broken bone in your wrist. The questionnaires will take about 20 minutes of your time to complete. At Week 26 you will be asked to record the amount of motion you have in both of your wrists on paper drawings as well as the measurements that we will make. Working with the drawings will take approximately five minutes. At Week 52 you will be asked two questions about how satisfied you are with the results of your surgery. Surgery, x-ray of your wrist, and exercise to help you get back motion of your broken wrist are all standard orthopedic practice for treating a broken wrist bone.

研究类型

介入性

注册 (实际的)

39

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

The following criteria must be met to be enrolled:

  1. Have a closed unstable distal radius fracture
  2. Have a fracture classified as an AO Type A or C fracture, with or without an ulnar styloid fracture
  3. Be a male or non-pregnant female at least 18 years of age.
  4. Understand the requirements of the study and able to provide a written informed consent and comply with the study protocol
  5. Have the ability to understand and provide written authorization for use and disclosure of personal health information

Exclusion Criteria:

Participants are excluded if they:

  1. Have any of the following conditions

    1. Concomitant contralateral or ipsilateral upper extremity fractures
    2. Ipsilateral ulna (excluding styloid) fracture
    3. Open, multi-fragmentary fracture
    4. Artery or Nerve injury secondary to fracture
  2. Have had a previous ipsilateral distal radius fracture in the 2 years prior to enrollment
  3. Are currently on chemotherapy or radiation therapy
  4. A history of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
  5. A history of uncontrolled diabetes
  6. Are unable to provide consent for the study
  7. Are unable to make the follow-up appointments required of the study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Early
Participants randomized to this arm will begin physical therapy of their fractured wrist approximately one week following surgery
Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture
其他:Delayed
Participants randomized to this group will begin physical therapy of their fractured wrist approximately 6 weeks from their surgery. This is the approximate time frame in which therapy begins for patients not involved in the study. The term Delayed refers to therapy being delayed in starting from those in the study who begin therapy at one week post-operatively, not a delay in current care practice.
Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Range of motion measurements
大体时间:at each study visit
at each study visit

次要结果测量

结果测量
大体时间
Pinch strength
大体时间:at each study visit
at each study visit
Grip strength
大体时间:at each study visit
at each study visit
Pain
大体时间:at each study visit
at each study visit
Return to work
大体时间:at each study visit
at each study visit
Scores of DASH & PRWE questionnaires
大体时间:at each study visit
at each study visit

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

合作者

调查人员

  • 首席研究员:Alexander Y. Shin, M.D.、Mayo Clinic

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年10月1日

初级完成 (实际的)

2010年2月1日

研究完成 (实际的)

2010年2月1日

研究注册日期

首次提交

2009年1月5日

首先提交符合 QC 标准的

2009年1月5日

首次发布 (估计)

2009年1月6日

研究记录更新

最后更新发布 (估计)

2011年4月8日

上次提交的符合 QC 标准的更新

2011年4月6日

最后验证

2011年4月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 06-004364

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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