Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty

NCT ID: NCT00916331

Last Updated: 2009-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2007-06-30

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.

Conditions

Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

subcutaneous group

Vacuum drainage is indwelled in subcutaneous layer

Group Type: EXPERIMENTAL

subcutaneous indwelling

Intervention Type: PROCEDURE

vacuum drainage is indwelled in subcutaneous layer

intraarticular group

Vacuum drainage is indwelled in intraarticular space

Group Type: EXPERIMENTAL

intraarticular indwelling

Intervention Type: PROCEDURE

vacuum drainage is indwelled in intraarticular space

Interventions

subcutaneous indwelling

vacuum drainage is indwelled in subcutaneous layer

Intervention Type: PROCEDURE

intraarticular indwelling

vacuum drainage is indwelled in intraarticular space

Intervention Type: PROCEDURE

Other Intervention Names

hemovac; hemovac

Eligibility 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

• Minimum Eligible Age: 54 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joint Recontruction Center, Seoul National University Bundang hospital

Principal Investigators

Tae Kyun Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Joint Recontruction Center, Seoul National University Bundang hospital

Locations

Joint Reconstruction Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

B-0606/034-008

Identifier Type: -

Identifier Source: org_study_id