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WRx Distal Radius Wrist Fracture Study

Primary Purpose

Wrist Fracture

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgical treatment of distal radius fractures
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrist Fracture focused on measuring Wrist Fracture

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Grip and Pinch
Measurements of grip and pinch strength will be taken using a pinch gauge and a dynamometer.

Full Information

First Posted
February 4, 2011
Last Updated
January 23, 2012
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01293227
Brief Title
WRx Distal Radius Wrist Fracture Study
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 Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Funding was withdrawn due to inadequete enrollment.
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This research project is a multi-year proposal, with the goals of answering and evaluating the following: 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? Does an intramedullary locking device applied in an extra-articular distal radius fracture improve patient related outcome measures compared to a volar locked plate?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrist Fracture
Keywords
Wrist Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Surgical treatment of distal radius fractures
Intervention Description
Surgical repair of distal radius fracture using either intramedullary locked nail or volar locked plate
Primary Outcome Measure Information:
Title
Change in Pain (to no pain)
Description
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.
Time Frame
Baseline to week 52 after surgery
Secondary Outcome Measure Information:
Title
Change in range of motion measurements
Description
Range of motion measurements will be measured using a goniometer and moving the hand and wrist into specific postitions.
Time Frame
Basline to week 52 after surgery
Title
Grip and Pinch
Description
Measurements of grip and pinch strength will be taken using a pinch gauge and a dynamometer.
Time Frame
Baseline to week 52 after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria The following criteria must be met to be enrolled: Have a closed extra-articular distal radius fracture or a minimally displaced intra-articular component Have a fracture classified as an AO Type A or C1 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 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: Have any of the following conditions Concomitant contralateral or ipsilateral upper extremity fractures Ipsilateral ulna (excluding styloid) fracture Open, multifragmentary fracture Unstable distal radioulnar joint after fracture fixation Artery or Nerve injury secondary to fracture Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity Currently on chemotherapy or radiation therapy History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis History of uncontrolled diabetes History of active rheumatologic disease with deformity History of chronic pain issues, psychiatric disorder which precludes reliable follow-up Unable to provide consent for the study Unable to make the follow-up appointments required of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Shin, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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WRx Distal Radius Wrist Fracture Study

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