Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty: Prospective Randomized Comparisons With Intraarticular Indwelling

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Procedure: subcutaneous indwelling
* Procedure: intraarticular indwelling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 54 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: subcutaneous group<br>Vacuum drainage is indwelled in subcutaneous layer | Procedure: subcutaneous indwelling<br>* vacuum drainage is indwelled in subcutaneous layer<br>* Other names: hemovac;|
| Experimental: intraarticular group<br>Vacuum drainage is indwelled in intraarticular space | Procedure: intraarticular indwelling<br>* vacuum drainage is indwelled in intraarticular space<br>* Other names: hemovac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfusion |  | during hospital stay | 
| wound problem |  | during hospital stay | 
| hypotension episode |  | during hospital stay | 
| functional outcome (ROM, AKS Knee score, WOMAC score, SF-36 score) |  | preoperative & postoperative 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee replacement arthroplasty, subcutaneous indwelling, blood loss, complications, functional status