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Completed

NCT Number: NCT00916331

Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty

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.

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Key information

Age range

54 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Joint Reconstruction Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

subcutaneous indwelling

Procedure

vacuum drainage is indwelled in subcutaneous layer

Other names: hemovac

intraarticular indwelling

Procedure

vacuum drainage is indwelled in intraarticular space

Other names: hemovac

Primary outcomes

  1. 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 outcomes

  1. transfusion

    Time frame: during hospital stay

  2. wound problem

    Time frame: during hospital stay

  3. hypotension episode

    Time frame: during hospital stay

  4. functional outcome (ROM, AKS Knee score, WOMAC score, SF-36 score)

    Time frame: preoperative & postoperative 1 year

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 9, 2009
Registry last updated
Jun 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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