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Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00916331
Enrollment
111
Registered
2009-06-09
Start date
2006-05-31
Completion date
2007-06-30
Last updated
2009-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty

Keywords

total knee replacement arthroplasty, subcutaneous indwelling, blood loss, complications, functional status

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.

Interventions

PROCEDUREsubcutaneous indwelling

vacuum drainage is indwelled in subcutaneous layer

PROCEDUREintraarticular indwelling

vacuum drainage is indwelled in intraarticular space

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
54 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
blood parameters by which we can estimate blood loss , such as drained blood volume, hemoglobin and hemoglobin drop24 hours after operation

Secondary

MeasureTime frame
transfusionduring hospital stay
wound problemduring hospital stay
hypotension episodeduring hospital stay
functional outcome (ROM, AKS Knee score, WOMAC score, SF-36 score)preoperative & postoperative 1 year

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026