WRx Distal Radius Wrist Fracture Study

This study has been terminated.
(Funding was withdrawn due to inadequete enrollment.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01293227
First received: February 4, 2011
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

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 Intervention
Wrist Fracture
Procedure: Surgical treatment of distal radius fractures

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in Pain (to no pain) [ Time Frame: Baseline to week 52 after surgery ] [ Designated as safety issue: No ]
    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:
  • Change in range of motion measurements [ Time Frame: Basline to week 52 after surgery ] [ Designated as safety issue: No ]
    Range of motion measurements will be measured using a goniometer and moving the hand and wrist into specific postitions.

  • Grip and Pinch [ Time Frame: Baseline to week 52 after surgery ] [ Designated as safety issue: No ]
    Measurements of grip and pinch strength will be taken using a pinch gauge and a dynamometer.


Enrollment: 6
Study Start Date: February 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Surgical treatment of distal radius fractures
    Surgical repair of distal radius fracture using either intramedullary locked nail or volar locked plate
  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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293227

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

No publications provided

Responsible Party: Alexander Shin, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01293227     History of Changes
Other Study ID Numbers: 10-005213
Study First Received: February 4, 2011
Last Updated: January 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Wrist Fracture

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 22, 2014