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 ] [ 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) |
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
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:
|
Radius Fractures Arm Injuries Forearm Injuries Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on March 03, 2015