Functional Outcome Following Fracture of the Distal Radius
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| First Received Date ICMJE | August 30, 2011 | ||||||||||||
| Last Updated Date | September 14, 2011 | ||||||||||||
| Start Date ICMJE | January 2011 | ||||||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Grip strength [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ] Maximum grip strength applied to a hand-held dynamometer, measured in kilograms |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01435070 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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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 | Functional Outcome Following Fracture of the Distal Radius | ||||||||||||
| Official Title ICMJE | A Correlation of Functional Outcome Measures of Fractures of the Distal Radius Following Operative Management | ||||||||||||
| Brief Summary | Patients attending the University Hospital Coventry UK with a broken wrist requiring an operation, will be invited to enter the study. At the first visit, they will have an xray of the wrist and will be asked to complete a number of questionnaires. The questions are to determine if they normally have pain in the wrist and how well they can perform their daily activities. The patient will then have an operation, and the fracture in the wrist will be held in the correct position with either a metal plate and screws or wires. At 6 weeks following the operation the patient will be reassessed and an xray will be taken. At 3 months, 6 months and 12 months after the operation patients will perform tests to assess the strength of their grip, pinch and movement of their wrist. In addition they will complete the the same questionnaires from their first visit. At the 12 month visit patients will have another xray. |
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| Detailed Description | Not Provided | ||||||||||||
| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||
| Study Population | All adult patients presenting to University Hospital Coventry with an acute fracture of the distal radius requiring operative management |
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| Condition ICMJE | Distal Radius Fractures | ||||||||||||
| Intervention ICMJE |
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| Study Group/Cohort (s) | Distal radius fracture
Patients aged 18 years and older with a fracture of the distal radius, within 3 cm of the radiocarpal joint
Interventions:
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| 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 | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||||||
| Estimated Completion Date | October 2013 | ||||||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01435070 | ||||||||||||
| Other Study ID Numbers ICMJE | IIS2010025 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Caroline Plant, University of Warwick | ||||||||||||
| Study Sponsor ICMJE | University of Warwick | ||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Warwick | ||||||||||||
| Verification Date | September 2011 | ||||||||||||
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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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