WRx Distal Radius Wrist Fracture Study

NCT ID: NCT01293227

Last Updated: 2012-01-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-01-31

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?

Conditions

Wrist Fracture

Study Design

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

Interventions

Surgical treatment of distal radius fractures

Surgical repair of distal radius fracture using either intramedullary locked nail or volar locked plate

Intervention Type: PROCEDURE

Eligibility 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

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

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Alexander Shin, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

10-005213

Identifier Type: -

Identifier Source: org_study_id