WRx Distal Radius Wrist Fracture Study

Wrist Fracture Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01293227
• Other study ID #: 10-005213
• Status: Terminated
• Phase: N/A
• First received: February 4, 2011
• Last updated: January 23, 2012
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Wrist Fracture

Intervention

Procedure:
• Surgical treatment of distal radius fractures
Surgical repair of distal radius fracture using either intramedullary locked nail or volar locked plate

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Basline to week 52 after surgery	No
Secondary	Grip and Pinch	Measurements of grip and pinch strength will be taken using a pinch gauge and a dynamometer.	Baseline to week 52 after surgery	No