- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01752452
Effect of Ulnar Styloid Fracture on the Outcome of Distal Radial Fractures Treated With External Fixation
December 14, 2012 updated by: Yi-xin Chen, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient treated with external fixation.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
106
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210008
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
unstable distal radial fracture patients: (1) the initial dorsal angulation >20°, (2) with dorsal or volar comminution of the metaphysis, (3) shortening of radius >5 mm, and (4) with an associated ulnar fracture.
Description
Inclusion Criteria:
- unstable distal radial fracture
- fixed with external fixator
Exclusion Criteria:
- multiple fracture
- open fracture
- nerve injury
- vascular injury
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
wrist motion range
Time Frame: 3 months, 6 months, and 1 year
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extension, flexion, radial deviation, ulnar deviation, forearm pronation and forearm supination
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3 months, 6 months, and 1 year
|
|
ulnar sided pain
Time Frame: 3 months, 6 months, and 1 year
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presence of ulnar-sided wrist pain during daily activities was recorded
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3 months, 6 months, and 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
radiographic analysis
Time Frame: 6 weeks, 3 months, and 1 year
|
Standard anterior-posterior and lateral radiographs were obtained at each time point to evaluate fracture healing and the alignment of the distal part of the radius.
Radial inclination, volar tilt, and radial height were measured
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6 weeks, 3 months, and 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yi-xin Chen, M.D., The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
December 11, 2012
First Submitted That Met QC Criteria
December 14, 2012
First Posted (Estimate)
December 19, 2012
Study Record Updates
Last Update Posted (Estimate)
December 19, 2012
Last Update Submitted That Met QC Criteria
December 14, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BE20116003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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