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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subcutaneous group | Experimental | Vacuum drainage is indwelled in subcutaneous layer |
|
| intraarticular group | Experimental | Vacuum drainage is indwelled in intraarticular space |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subcutaneous indwelling | Procedure | vacuum drainage is indwelled in subcutaneous layer |
|
| Measure | Description | Time Frame |
|---|---|---|
| blood parameters by which we can estimate blood loss , such as drained blood volume, hemoglobin and hemoglobin drop | 24 hours after operation |
| Measure | Description | Time Frame |
|---|---|---|
| transfusion | during hospital stay | |
| wound problem | during hospital stay | |
| hypotension episode |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tae Kyun Kim, MD, PhD | Joint Recontruction Center, Seoul National University Bundang hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Reconstruction Center, Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 30, 2013 | |
| Reset | Dec 20, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 30, 2013 | Dec 20, 2013 |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| intraarticular indwelling | Procedure | vacuum drainage is indwelled in intraarticular space |
|
|
| during hospital stay |
| functional outcome (ROM, AKS Knee score, WOMAC score, SF-36 score) | preoperative & postoperative 1 year |