WRx Distal Radius Wrist Fracture Study

• Sponsor: Mayo Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01293227
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Duration (Months): 11
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Feb 1, 2011
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Outcome Measures

Primary Outcome Measures

1. Change in Pain (to no pain) [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 [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 [Baseline to week 52 after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• 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

2. Concomitant contralateral or ipsilateral upper extremity fractures

3. Ipsilateral ulna (excluding styloid) fracture

4. Open, multifragmentary fracture

5. Unstable distal radioulnar joint after fracture fixation

6. Artery or Nerve injury secondary to fracture

7. Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity

8. Currently on chemotherapy or radiation therapy

9. History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis

10. History of uncontrolled diabetes

11. History of active rheumatologic disease with deformity

12. History of chronic pain issues, psychiatric disorder which precludes reliable follow-up

13. Unable to provide consent for the study

14. Unable to make the follow-up appointments required of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Alexander Shin, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01293227
• Other Study ID Numbers: 10-005213
• First Posted: Feb 10, 2011
• Last Update Posted: Jan 24, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by , ,: Wrist Fracture
• Additional relevant MeSH terms: Fractures, Bone

Study Results

No Results Posted as of Jan 24, 2012