Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty
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ClinicalTrials.gov Identifier: NCT00916331 |
Recruitment Status
:
Completed
First Posted
: June 9, 2009
Last Update Posted
: June 9, 2009
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Sponsor:
Seoul National University Hospital
Information provided by:
Seoul National University Hospital
Tracking Information | ||||
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First Submitted Date ICMJE | May 15, 2009 | |||
First Posted Date ICMJE | June 9, 2009 | |||
Last Update Posted Date | June 9, 2009 | |||
Study Start Date ICMJE | May 2006 | |||
Actual Primary Completion Date | June 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
blood parameters by which we can estimate blood loss , such as drained blood volume, hemoglobin and hemoglobin drop [ Time Frame: 24 hours after operation ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
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 | Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty | |||
Official Title ICMJE | Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty: Prospective Randomized Comparisons With Intraarticular Indwelling | |||
Brief Summary | This prospective, randomized trial asked whether subcutaneous indwelling of vacuum drainage has advantages over intraarticular indwelling in terms of blood loss, bleeding related complications, and functional outcomes in primary total knee arthroplasty (TKA). The investigators hypothesized that the subcutaneous indwelling method would reduce blood loss with comparable bleeding-related complications and functional outcomes. The subcutaneous indwelling group demonstrated reduced blood loss with comparable prevalence of bleeding-related complications and functional outcomes. In conclusion, the investigators' study verified the efficacy and absence of risks of subcutaneous indwelling method. So the investigators propose that the subcutaneous indwelling drainage can be a good option to address the problems related to postoperative bleeding after TKA. | |||
Detailed Description | There are numerous reports in the literature on drainage options after TKA, but there is no consensus. Many studies have shown no apparent advantage of drainage but routine intraarticular indwelling drainage after TKA has been extensively used to avoid complications associated with hematoma formation. It is of interest to determine if it is possible to reduce blood loss while still using drainage. So we came to think about a new and more convenient method-subcutaneous indwelling. Theoretically subcutaneous indwelling method which still has the advantages over the intraarticular indwelling method but is more convenient than drain-clamping method may be a better option. So we hypothesized that subcutaneous indwelling method of vacuum drainage has advantages over the intraarticular indwelling method. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Total Knee Arthroplasty | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE |
111 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | June 2007 | |||
Actual Primary Completion Date | June 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 54 Years to 85 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00916331 | |||
Other Study ID Numbers ICMJE | B-0606/034-008 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Tae Kyun Kim, Joint Recontruction Center, Seoul National University Bundang hospital | |||
Study Sponsor ICMJE | Seoul National University Hospital | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Seoul National University Hospital | |||
Verification Date | June 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |