Range of Motion and Patients With Distal Radius Fractures

NCT ID: NCT00816998

Last Updated: 2011-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-02-28

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.

Conditions

Radius Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early

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

Group Type: OTHER

Physical therapy

Intervention Type: PROCEDURE

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

Physical Therapy

Intervention Type: PROCEDURE

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.

Group Type: OTHER

Physical therapy

Intervention Type: PROCEDURE

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

Physical Therapy

Intervention Type: PROCEDURE

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

Interventions

Physical therapy

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Alexander Y. Shin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

06-004364

Identifier Type: -

Identifier Source: org_study_id