Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty

Phase 4

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Procedure: intraarticular indwelling; Procedure: subcutaneous indwelling

• Registration Number: NCT00916331
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2006-05
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Study First Submitted: 2009-05-15
• Status Verified: 2009-06
• Study First Submitted QC: 2009-06-05
• Last Update Submitted: 2009-06-05
• Study First Posted: 2009-06-09
• Last Update Posted: 2009-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intraarticular group	intraarticular indwelling	Vacuum drainage is indwelled in intraarticular space
subcutaneous group	subcutaneous indwelling	Vacuum drainage is indwelled in subcutaneous layer

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
transfusion	during hospital stay
hypotension episode	during hospital stay
wound problem	during hospital stay
functional outcome (ROM, AKS Knee score, WOMAC score, SF-36 score)	preoperative & postoperative 1 year

Trial Locations

Locations (1)

Joint Reconstruction Center, Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of