Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty

Tracking Information
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; (submitted: June 5, 2009)	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; (submitted: June 5, 2009)	transfusion [ Time Frame: during hospital stay ]; wound problem [ Time Frame: during hospital stay ]; hypotension episode [ Time Frame: during hospital stay ]; functional outcome (ROM, AKS Knee score, WOMAC score, SF-36 score) [ Time Frame: preoperative & postoperative 1 year ]
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
Condition ICMJE	Total Knee Arthroplasty
Intervention ICMJE	Procedure: subcutaneous indwelling vacuum drainage is indwelled in subcutaneous layer Other Name: hemovac; Procedure: intraarticular indwelling vacuum drainage is indwelled in intraarticular space Other Name: hemovac
Study Arms	Experimental: subcutaneous group Vacuum drainage is indwelled in subcutaneous layer Intervention: Procedure: subcutaneous indwelling; Experimental: intraarticular group Vacuum drainage is indwelled in intraarticular space Intervention: Procedure: intraarticular indwelling
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 5, 2009)	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: Diagnosis of primary osteoarthritis; primary total knee arthroplasty; Signed written informed consent; Spinal/epidural anesthesia Exclusion Criteria: Patients with coagulation disorders; Revision total knee arthroplasty; Simultaneous bilateral total knee arthroplasty; Diagnosis other than primary osteoarthritis; Patients refusing consents
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Tae Kyun Kim, MD, PhD Joint Recontruction Center, Seoul National University Bundang hospital
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