Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty

This study has been completed.

Sponsor:

Information provided by:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT00916331

First received: May 15, 2009

Last updated: June 5, 2009

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 15, 2009

Last Updated Date

June 5, 2009

Start Date ^ICMJE

May 2006

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

blood parameters by which we can estimate blood loss , such as drained blood volume, hemoglobin and hemoglobin drop [ Time Frame: 24 hours after operation ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00916331 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

transfusion [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]
wound problem [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]
hypotension episode [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]
functional outcome (ROM, AKS Knee score, WOMAC score, SF-36 score) [ Time Frame: preoperative & postoperative 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Total Knee Arthroplasty

Intervention ^ICMJE

Procedure: subcutaneous indwelling
vacuum drainage is indwelled in subcutaneous layer

Other Name: hemovac
Procedure: intraarticular indwelling
vacuum drainage is indwelled in intraarticular space

Other Name: hemovac

Study Arm (s)

Experimental: subcutaneous group
Vacuum drainage is indwelled in subcutaneous layer

Intervention: Procedure: subcutaneous indwelling
Experimental: intraarticular group
Vacuum drainage is indwelled in intraarticular space

Intervention: Procedure: intraarticular indwelling

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

111

Completion Date

June 2007

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

54 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00916331

Other Study ID Numbers ^ICMJE

B-0606/034-008

Has Data Monitoring Committee

Responsible Party

Tae Kyun Kim, Joint Recontruction Center, Seoul National University Bundang hospital

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Tae Kyun Kim, MD, PhD

Joint Recontruction Center, Seoul National University Bundang hospital

Information Provided By

Seoul National University Hospital

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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