WRx Distal Radius Wrist Fracture Study

NCT01293227 | Terminated

• 1 other identifier: 10-005213
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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

Keywords

Wrist Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in range of motion measurements

  Basline to week 52 after surgery

• Grip and Pinch

  Baseline to week 52 after surgery

Interventions

Surgical treatment of distal radius fractures PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Alexander Shin, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 10, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 24, 2012

Record last verified: 2012-01

Locations

US (1)