WRx Distal Radius Wrist Fracture Study

The Effect of Intramedullary Locked Nail Versus Volar Locked Plating in the Treatment of Extra-articular and Minimally Displaced Intra-articular Distal Radius Fractures: A Prospective Randomized Trial.

This research project is a multi-year proposal, with the goals of answering and evaluating the following:

1. Does an intramedullary locking device applied in an extra-articular distal radius fracture improve post operative pain, diminish hospitalization, improve early return to activity and function compared to a volar locked plate?
2. Does an intramedullary locking device applied in an extra-articular distal radius fracture improve patient related outcome measures compared to a volar locked plate?

Study Overview

• Status: Terminated
• Conditions: Wrist Fracture
• Intervention / Treatment: Procedure: Surgical treatment of distal radius fractures

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

The following criteria must be met to be enrolled:

1. Have a closed extra-articular distal radius fracture or a minimally displaced intra-articular component
2. Have a fracture classified as an AO Type A or C1 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
6. Have a fracture that can be closed reduced to acceptable radiographic parameters (minimum of neutral volar tilt, greater than or equal to 15 degrees of radial inclination and at least 10 mm of radial height as compared to the opposite side)

Exclusion Criteria

Subjects are excluded if:

1. Have any of the following conditions

   1. Concomitant contralateral or ipsilateral upper extremity fractures
   2. Ipsilateral ulna (excluding styloid) fracture
   3. Open, multifragmentary fracture
   4. Unstable distal radioulnar joint after fracture fixation
   5. Artery or Nerve injury secondary to fracture
2. Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity
3. Currently on chemotherapy or radiation therapy
4. History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
5. History of uncontrolled diabetes
6. History of active rheumatologic disease with deformity
7. History of chronic pain issues, psychiatric disorder which precludes reliable follow-up
8. Unable to provide consent for the study
9. Unable to make the follow-up appointments required of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain (to no pain)	Postoperative pain will be monitored by recording of the consumption of narcotic pain medications converted to morphine equivalents. Participants will record medications taken in a Pain Diary. They will also be asked to complete a Visual Analog scale questionnaire regarding their pain.	Baseline to week 52 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in range of motion measurements	Range of motion measurements will be measured using a goniometer and moving the hand and wrist into specific postitions.	Basline to week 52 after surgery
Grip and Pinch	Measurements of grip and pinch strength will be taken using a pinch gauge and a dynamometer.	Baseline to week 52 after surgery

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (Estimate): February 10, 2011

Study Record Updates

• Last Update Posted (Estimate): January 24, 2012
• Last Update Submitted That Met QC Criteria: January 23, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Wrist Fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 10-005213