A Phase 4 interventional study of subcutaneous indwelling and intraarticular indwelling in Total Knee Arthroplasty, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 54 Years to 85 Years. Per ClinicalTrials.gov, last updated 2009-06-09.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
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.
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.
Seoul National University Hospital is the lead sponsor of 1,859 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vacuum drainage is indwelled in subcutaneous layer
Procedure: subcutaneous indwelling
Vacuum drainage is indwelled in intraarticular space
Procedure: intraarticular indwelling
vacuum drainage is indwelled in subcutaneous layer
Also known as: hemovac
vacuum drainage is indwelled in intraarticular space
Also known as: hemovac
blood parameters by which we can estimate blood loss , such as drained blood volume, hemoglobin and hemoglobin drop
Time frame: 24 hours after operation
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
This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital