Effect of Ulnar Styloid Fracture on the Outcome of Distal Radial Fractures Treated With External Fixation
This study has been completed.
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Information provided by (Responsible Party):
Yi-xin Chen, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT01752452
First received: December 11, 2012
Last updated: December 14, 2012
Last verified: December 2012
| Tracking Information | |||||
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| First Received Date ICMJE | December 11, 2012 | ||||
| Last Updated Date | December 14, 2012 | ||||
| Start Date ICMJE | January 2009 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01752452 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
radiographic analysis [ Time Frame: 6 weeks, 3 months, and 1 year ] [ Designated as safety issue: No ] 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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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Ulnar Styloid Fracture on the Outcome of Distal Radial Fractures Treated With External Fixation | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | Untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient treated with external fixation. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational [Patient Registry] | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | 2 Years | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 106 | ||||
| Completion Date | October 2012 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01752452 | ||||
| Other Study ID Numbers ICMJE | BE20116003 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Yi-xin Chen, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||||
| Study Sponsor ICMJE | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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