Effect of Preop Nutritional Status on Outcomes of Staged Bilateral Total Knee Arthroplasty
This study is enrolling participants by invitation only.
Sponsor:
Heekin Orthopedic Research Institute
Information provided by (Responsible Party):
R. David Heekin, Heekin Orthopedic Research Institute
ClinicalTrials.gov Identifier:
NCT01545362
First received: March 1, 2012
Last updated: March 19, 2013
Last verified: March 2012
| Tracking Information | |||||
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| First Received Date ICMJE | March 1, 2012 | ||||
| Last Updated Date | March 19, 2013 | ||||
| Start Date ICMJE | November 2011 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Blood loss until drain is pulled [ Time Frame: postoperatively ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01545362 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 | Effect of Preop Nutritional Status on Outcomes of Staged Bilateral Total Knee Arthroplasty | ||||
| Official Title ICMJE | The Effect of Preop Nutritional Status on Outcomes of Staged Bilateral Total Knee Replacements Performed Within One Week | ||||
| Brief Summary | To determine if preop nutritional status is an indicator for outcomes of bilateral staged total knee arthroplasty. The investigators expect that patients having staged bilateral total knee arthroplasty with the second procedure performed within one week of the first and have a total lymphocyte count >1500 per cubic millimeter and serum albumin level >35 grams per liter will have the same or less complications and shorter length of stay than those with lower lymphocyte count and albumin level. |
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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 | Cohort selected from patients in orthopaedic clinic |
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| Condition ICMJE | Arthritis | ||||
| Intervention ICMJE | Procedure: Total knee arthroplasty
Total knee arthroplasty |
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| Study Group/Cohort (s) | Staged bilateral total knee arthroplasty
Patients that have bilateral total knee arthroplasty staged within one week
Intervention: Procedure: Total knee 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 | Enrolling by invitation | ||||
| Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | March 2014 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01545362 | ||||
| Other Study ID Numbers ICMJE | 2010-004 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | R. David Heekin, Heekin Orthopedic Research Institute | ||||
| Study Sponsor ICMJE | Heekin Orthopedic Research Institute | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Heekin Orthopedic Research Institute | ||||
| Verification Date | March 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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