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Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00916331
First Posted: June 9, 2009
Last Update Posted: June 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seoul National University Hospital
  Purpose
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.

Condition Intervention Phase
Total Knee Arthroplasty Procedure: subcutaneous indwelling Procedure: intraarticular indwelling Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty: Prospective Randomized Comparisons With Intraarticular Indwelling

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • blood parameters by which we can estimate blood loss , such as drained blood volume, hemoglobin and hemoglobin drop [ Time Frame: 24 hours after operation ]

Secondary Outcome Measures:
  • transfusion [ Time Frame: during hospital stay ]
  • wound problem [ Time Frame: during hospital stay ]
  • hypotension episode [ Time Frame: during hospital stay ]
  • functional outcome (ROM, AKS Knee score, WOMAC score, SF-36 score) [ Time Frame: preoperative & postoperative 1 year ]

Enrollment: 111
Study Start Date: May 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: subcutaneous group
Vacuum drainage is indwelled in subcutaneous layer
Procedure: subcutaneous indwelling
vacuum drainage is indwelled in subcutaneous layer
Other Name: hemovac
Experimental: intraarticular group
Vacuum drainage is indwelled in intraarticular space
Procedure: intraarticular indwelling
vacuum drainage is indwelled in intraarticular space
Other Name: hemovac

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.
  Eligibility

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Ages Eligible for Study:   54 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916331


Locations
Korea, Republic of
Joint Reconstruction Center, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Tae Kyun Kim, MD, PhD Joint Recontruction Center, Seoul National University Bundang hospital
  More Information

Responsible Party: Tae Kyun Kim, Joint Recontruction Center, Seoul National University Bundang hospital
ClinicalTrials.gov Identifier: NCT00916331     History of Changes
Other Study ID Numbers: B-0606/034-008
First Submitted: May 15, 2009
First Posted: June 9, 2009
Last Update Posted: June 9, 2009
Last Verified: June 2009

Keywords provided by Seoul National University Hospital:
total knee replacement arthroplasty
subcutaneous indwelling
blood loss
complications
functional status