Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Procedure: subcutaneous indwelling; Procedure: intraarticular indwelling

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: Interventional
• Enrollment (Actual): 111
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Joint Reconstruction Center, Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 54 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: subcutaneous group; Vacuum drainage is indwelled in subcutaneous layer	Procedure: subcutaneous indwelling; vacuum drainage is indwelled in subcutaneous layer; Other Names: hemovac
Experimental: intraarticular group; Vacuum drainage is indwelled in intraarticular space	Procedure: intraarticular indwelling; vacuum drainage is indwelled in intraarticular space; Other Names: hemovac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Tae Kyun Kim, MD, PhD, Joint Recontruction Center, Seoul National University Bundang hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: May 15, 2009
• First Submitted That Met QC Criteria: June 5, 2009
• First Posted (Estimate): June 9, 2009

Study Record Updates

• Last Update Posted (Estimate): June 9, 2009
• Last Update Submitted That Met QC Criteria: June 5, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: blood loss; complications; functional status; total knee replacement arthroplasty; subcutaneous indwelling
• Other Study ID Numbers: B-0606/034-008