Clinical Trial: Range of Motion and Patients With Distal Radius Fractures

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary: 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.
Sponsor: Mayo Clinic

Current Primary Outcome: Range of motion measurements [ Time Frame: at each study visit ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pinch strength [ Time Frame: at each study visit ]
  • Grip strength [ Time Frame: at each study visit ]
  • Pain [ Time Frame: at each study visit ]
  • Return to work [ Time Frame: at each study visit ]
  • Scores of DASH & PRWE questionnaires [ Time Frame: at each study visit ]


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: January 5, 2009
Date Started: October 2006
Date Completion:
Last Updated: April 6, 2011
Last Verified: April 2011