Uncemented Total Elbow Arthroplasty Data Collection
| Tracking Information | |||||
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| First Received Date ICMJE | September 2, 2009 | ||||
| Last Updated Date | February 4, 2013 | ||||
| Start Date ICMJE | March 2009 | ||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Patient examination measurements and radiographic measurements will be used to determine the effects of an uncemented total elbow arthroplasty [ Time Frame: Pre-operative to five year post-operative appointment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00974298 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Uncemented Total Elbow Arthroplasty Data Collection | ||||
| Official Title ICMJE | Uncemented Total Elbow Arthroplasty Data Collection | ||||
| Brief Summary | The purpose of this study is to document the performance and clinical outcomes of uncemented total elbow replacements involving the press-fit technique performed at the Vanderbilt Hand Center. The press-fit use technique is often used because of complications with cement loosening. |
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| Detailed Description | The three parts of this study will be: Retrospective Chart Review- A chart review will be completed on all patients that have had an uncemented total elbow arthroplasty using the press-fit technique at Vanderbilt Hand & Upper Extremity Center. The chart review will include:
Questionnaire Mailing- We will mail prospective study patients a DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire to complete with a mailing letter explaining the request for this information. The DASH will be modified to ask patients regarding their pre-operative time as well. Clinical Data Collection- We will enroll patients who have already had/or will be having a uncemented total elbow arthroplasty using the press-fit technique. If the patient already has a file completed through the chart review we will not complete the historical data form, operative form, or previous radiograph assessments. If the patient does not have a file completed through the chart review the data collection will include:
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients who require total elbow arthroplasty. |
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| Condition ICMJE | Total Elbow Arthroplasty | ||||
| Intervention ICMJE | Procedure: Total elbow replacement arthroplasty
Total elbow arthroplasty using pressfit technique in which no cement is used. |
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| Study Group/Cohort (s) | Elbow replacement
There are no other arms other then an uncemented total elbow replacement.
Intervention: Procedure: Total elbow replacement arthroplasty |
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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 | 100 | ||||
| Estimated Completion Date | March 2014 | ||||
| Estimated Primary Completion Date | March 2014 (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 States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00974298 | ||||
| Other Study ID Numbers ICMJE | 090342 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Donald Lee, Vanderbilt University | ||||
| Study Sponsor ICMJE | Vanderbilt University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt University | ||||
| Verification Date | February 2013 | ||||
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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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