Outcome Study of Complex Distal Radius Fractures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00160810
First received: September 8, 2005
Last updated: May 17, 2013
Last verified: June 2012
  Purpose

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.


Condition Phase
Distal Radius Fractures
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Outcome Study of Complex Distal Radius Fractures: Open Reduction Internal Fixation (ORIF) With A Volar Fixed Angled Plate Versus A Distal Radius Volar (DRV) Plate Versus External Fixation

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Wrist Range of Motion [ Time Frame: one year post-op ] [ Designated as safety issue: No ]
    An improvement of all aspects of wrist motion (extension, flexion, supination and pronation) over one year post-op.


Secondary Outcome Measures:
  • Disabilities of the Arm, Shoulder and Hand (DASH) and Patient Rated Wrist Evaluation (PRWE) scores [ Time Frame: one year post-op ] [ Designated as safety issue: No ]
    An improvement of the DASH and PRWE scores over one year post-op.


Enrollment: 74
Study Start Date: April 2001
Study Completion Date: June 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Orthopaedic clinic

Criteria

Inclusion Criteria:

  • distal radius fracture

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160810

Locations
United States, Florida
UF and Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Thomas W. Wright, M.D. University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00160810     History of Changes
Other Study ID Numbers: 86-2001
Study First Received: September 8, 2005
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
distal
radius
fractures

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on April 16, 2014