WRx Distal Radius Wrist Fracture Study | NCT01293227

Studies
WRx Distal Radius Wrist Fracture Study

NCT01293227

Sponsor

Mayo Clinic

Status

Terminated

Last Update Posted

Jan 24, 2012Estimated

Enrollment

6Actual

Phase

Not Applicable

Conditions

Wrist Fracture

Interventions

Surgical treatment of distal radius fractures

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding was withdrawn due to inadequete enrollment.

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Feb 4, 2011

First Submission Date that Met QC Criteria

Feb 9, 2011

First Posted Date

Feb 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2012

Last Update Posted Date

Jan 24, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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?
Does an intramedullary locking device applied in an extra-articular distal radius fracture improve patient related outcome measures compared to a volar locked plate?

Detailed Description

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Surgical treatment of distal radius fractures	Procedure	Surgical repair of distal radius fracture using either intramedullary locked nail or volar locked plate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Grip and Pinch

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

Subjects are excluded if:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014954	Wrist Injuries
D001134	Arm Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone