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

May 15, 2009
June 5, 2009
May 2006
June 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00916331 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Total Knee Arthroplasty
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
54 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00916331
B-0606/034-008
No
Tae Kyun Kim, Joint Recontruction Center, Seoul National University Bundang hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Tae Kyun Kim, MD, PhD Joint Recontruction Center, Seoul National University Bundang hospital
Seoul National University Hospital
June 2009

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