Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Total Knee Arthroplasty

Treatments: Procedure: intraarticular indwelling; Procedure: subcutaneous indwelling

Study type: Interventional

Funder types: Other

Identifiers

NCT00916331

B-0606/034-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 54 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 2 patient groups

subcutaneous group

Experimental group

Description:

Vacuum drainage is indwelled in subcutaneous layer

Treatment:

Procedure: subcutaneous indwelling

intraarticular group

Experimental group

Description:

Vacuum drainage is indwelled in intraarticular space

Treatment:

Procedure: intraarticular indwelling