NCT00160810

Brief Summary

The purpose of this study is to collect information about how people do after different treatments of a broken wrist to see if one treatment has better results.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 20, 2013

Status Verified

June 1, 2012

Enrollment Period

9.5 years

First QC Date

September 8, 2005

Last Update Submit

May 17, 2013

Conditions

Distal Radius Fractures

Keywords

distalradiusfractures

Outcome Measures

Primary Outcomes (1)

  • Wrist Range of Motion

    An improvement of all aspects of wrist motion (extension, flexion, supination and pronation) over one year post-op.

    one year post-op

Secondary Outcomes (1)

  • Disabilities of the Arm, Shoulder and Hand (DASH) and Patient Rated Wrist Evaluation (PRWE) scores

    one year post-op

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Orthopaedic clinic

You may qualify if:

  • distal radius fracture

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF and Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Wrist FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and Injuries

Study Officials

  • Thomas W. Wright, M.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

April 1, 2001

Primary Completion

October 1, 2010

Study Completion

June 1, 2012

Last Updated

May 20, 2013

Record last verified: 2012-06

Locations

US(1)