Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916331
• Other study ID #: B-0606/034-008
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2009
• Last updated: June 5, 2009
• Start date: May 2006
• Est. completion date: June 2007

Study information

• Verified date: June 2009
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 54 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Procedure:
• subcutaneous indwelling
vacuum drainage is indwelled in subcutaneous layer
• intraarticular indwelling
vacuum drainage is indwelled in intraarticular space

Locations

Country	Name	City	State
Korea, Republic of	Joint Reconstruction Center, Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood parameters by which we can estimate blood loss , such as drained blood volume, hemoglobin and hemoglobin drop		24 hours after operation
Secondary	transfusion		during hospital stay
Secondary	wound problem		during hospital stay
Secondary	hypotension episode		during hospital stay
Secondary	functional outcome (ROM, AKS Knee score, WOMAC score, SF-36 score)		preoperative & postoperative 1 year