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Outcome Study of Complex Distal Radius Fractures
This study has been completed.
Sponsor:
University of Florida
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
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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.
| 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 ]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 ]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) |
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Orthopaedic clinic
Criteria
Inclusion Criteria:
- distal radius fracture
Exclusion Criteria:
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00160810
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
| 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 |
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 August 18, 2017