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Range of Motion and Patients With Distal Radius Fractures

Primary Purpose

Radius Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical therapy
Physical Therapy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radius Fractures focused on measuring Radius fractures

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Early

Delayed

Arm Description

Participants randomized to this arm will begin physical therapy of their fractured wrist approximately one week following surgery

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.

Outcomes

Primary Outcome Measures

Range of motion measurements

Secondary Outcome Measures

Pinch strength
Grip strength
Pain
Return to work
Scores of DASH & PRWE questionnaires

Full Information

First Posted
January 5, 2009
Last Updated
April 6, 2011
Sponsor
Mayo Clinic
Collaborators
DePuy Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT00816998
Brief Title
Range of Motion and Patients With Distal Radius Fractures
Official Title
The Effect of Early vs. Delayed Range of Motion in the Outcome of Patients With Distal Radius Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
DePuy Orthopaedics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fractures
Keywords
Radius fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early
Arm Type
Other
Arm Description
Participants randomized to this arm will begin physical therapy of their fractured wrist approximately one week following surgery
Arm Title
Delayed
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Physical therapy
Intervention Description
Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Intervention Description
Physical therapy to include exercises to help a participant improve the range of motion, grip and pinch strength following the fracture of their wrist
Primary Outcome Measure Information:
Title
Range of motion measurements
Time Frame
at each study visit
Secondary Outcome Measure Information:
Title
Pinch strength
Time Frame
at each study visit
Title
Grip strength
Time Frame
at each study visit
Title
Pain
Time Frame
at each study visit
Title
Return to work
Time Frame
at each study visit
Title
Scores of DASH & PRWE questionnaires
Time Frame
at each study visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The following criteria must be met to be enrolled: Have a closed unstable distal radius fracture Have a fracture classified as an AO Type A or C fracture, with or without an ulnar styloid fracture Be a male or non-pregnant female at least 18 years of age. Understand the requirements of the study and able to provide a written informed consent and comply with the study protocol Have the ability to understand and provide written authorization for use and disclosure of personal health information Exclusion Criteria: Participants are excluded if they: Have any of the following conditions Concomitant contralateral or ipsilateral upper extremity fractures Ipsilateral ulna (excluding styloid) fracture Open, multi-fragmentary fracture Artery or Nerve injury secondary to fracture Have had a previous ipsilateral distal radius fracture in the 2 years prior to enrollment Are currently on chemotherapy or radiation therapy A history of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis A history of uncontrolled diabetes Are unable to provide consent for the study Are unable to make the follow-up appointments required of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Y. Shin, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Range of Motion and Patients With Distal Radius Fractures

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