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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   54 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 15, 2009
Last Updated: June 5, 2009
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014