Outcome Study of Complex Distal Radius Fractures | NCT00160810

Studies
Outcome Study of Complex Distal Radius Fractures

NCT00160810

Sponsor

University of Florida

Status

Completed

Last Update Posted

May 20, 2013Estimated

Enrollment

74Actual

Phase

Not provided

Conditions

Distal Radius Fractures

Interventions

Not provided

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

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2001

Primary Completion Date

Oct 2010Actual

Completion Date

Jun 2012Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 11, 2005

First Posted Date

Sep 12, 2005Estimated

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

May 17, 2013

Last Update Posted Date

May 20, 2013Estimated

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

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.

Detailed Description

Complex distal radius fractures are a common problem treated by orthopaedic surgeons. The purpose of this study is to compare the outcome between complex distal radius fractures treated with open reduction and internal fixation using a volar fixed angled plate versus and external fixator versus DRV. The hypothesis is that the volar fixed angled plate will have a superior outcome both radiographically and clinically.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Disabilities of the Arm, Shoulder and Hand (DASH) and Patient Rated Wrist Evaluation (PRWE) scores	An improvement of the DASH and PRWE scores over one year post-op.	one year post-op

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

distal radius fracture

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Orthopaedic clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas W. Wright, M.D.	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UF and Shands Orthopaedics and Sports Medicine Institute		Gainesville	Florida	32611	United States

Condition Browse Module

MeSH Terms

ID	Term
D000092503	Wrist Fractures
D050723	Fractures, Bone

Ancestor Terms

ID	Term
D014954	Wrist Injuries
D001134	Arm Injuries
D014947	Wounds and Injuries

Browse Leaves

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Browse Branches

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