WRx Distal Radius Wrist Fracture Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01293227
Recruitment Status : Terminated (Funding was withdrawn due to inadequete enrollment.)
First Posted : February 10, 2011
Last Update Posted : January 24, 2012
Information provided by:
Mayo Clinic

Brief Summary:

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?

Condition or disease Intervention/treatment Phase
Wrist Fracture Procedure: Surgical treatment of distal radius fractures Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : February 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Procedure: Surgical treatment of distal radius fractures
    Surgical repair of distal radius fracture using either intramedullary locked nail or volar locked plate

Primary Outcome Measures :
  1. Change in Pain (to no pain) [ Time Frame: Baseline to week 52 after surgery ]
    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.

Secondary Outcome Measures :
  1. Change in range of motion measurements [ Time Frame: Basline to week 52 after surgery ]
    Range of motion measurements will be measured using a goniometer and moving the hand and wrist into specific postitions.

  2. Grip and Pinch [ Time Frame: Baseline to week 52 after surgery ]
    Measurements of grip and pinch strength will be taken using a pinch gauge and a dynamometer.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01293227

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Alexander Shin, MD Mayo Clinic

Responsible Party: Alexander Shin, MD, Mayo Clinic Identifier: NCT01293227     History of Changes
Other Study ID Numbers: 10-005213
First Posted: February 10, 2011    Key Record Dates
Last Update Posted: January 24, 2012
Last Verified: January 2012

Keywords provided by Mayo Clinic:
Wrist Fracture

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries