Range of Motion and Patients With Distal Radius Fractures - Full Text View

Sponsors and Collaborators:	Mayo Clinic DePuy Orthopaedics
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00816998

Purpose

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.

Condition	Intervention
Radius Fractures	Procedure: Physical therapy Procedure: Physical Therapy

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Early vs. Delayed Range of Motion in the Outcome of Patients With Distal Radius Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Range of motion measurements [ Time Frame: at each study visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pinch strength [ Time Frame: at each study visit ] [ Designated as safety issue: No ]
Grip strength [ Time Frame: at each study visit ] [ Designated as safety issue: No ]
Pain [ Time Frame: at each study visit ] [ Designated as safety issue: No ]
Return to work [ Time Frame: at each study visit ] [ Designated as safety issue: No ]
Scores of DASH & PRWE questionnaires [ Time Frame: at each study visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	October 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Early Participants randomized to this arm will begin physical therapy of their fractured wrist approximately one week following surgery	Procedure: Physical therapy Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture Procedure: Physical Therapy Physical therapy to include exercises to help a participant improve the range of motion, grip and pinch strength following the fracture of their wrist
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.	Procedure: Physical therapy Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture Procedure: Physical Therapy Physical therapy to include exercises to help a participant improve the range of motion, grip and pinch strength following the fracture of their wrist

Arms

Assigned Interventions

Early

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

Procedure: Physical therapy

Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture

Procedure: Physical Therapy

Physical therapy to include exercises to help a participant improve the range of motion, grip and pinch strength following the fracture of their wrist

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.

Procedure: Physical therapy

Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture

Procedure: Physical Therapy

Physical therapy to include exercises to help a participant improve the range of motion, grip and pinch strength following the fracture of their wrist

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816998

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

DePuy Orthopaedics

Investigators

Principal Investigator:

Alexander Y. Shin, M.D.

Mayo Clinic

More Information

No publications provided

Responsible Party:	Mayo Clinic ( Alexander Y. Shin, M.D. )
Study ID Numbers:	06-004364
Study First Received:	January 5, 2009
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00816998 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Radius fractures

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Forearm Injuries

Disorders of Environmental Origin
Radius Fractures
Arm Injuries

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Forearm Injuries

Disorders of Environmental Origin
Radius Fractures
Arm Injuries

ClinicalTrials.gov processed this record on September 02, 2009