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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01293227
Other study ID # 10-005213
Secondary ID
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


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
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