Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty

NCT00916331 | Completed Phase 4

• 1 other identifier: B-0606/034-008
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Keywords

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

Outcome Measures

Primary Outcomes (1)

• blood parameters by which we can estimate blood loss , such as drained blood volume, hemoglobin and hemoglobin drop

  24 hours after operation

Secondary Outcomes (4)

• transfusion

  during hospital stay

• wound problem

  during hospital stay

• hypotension episode

  during hospital stay

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

  preoperative & postoperative 1 year

Study Arms (2)

subcutaneous group

EXPERIMENTAL

Vacuum drainage is indwelled in subcutaneous layer

Procedure: subcutaneous indwelling

intraarticular group

EXPERIMENTAL

Vacuum drainage is indwelled in intraarticular space

Procedure: intraarticular indwelling

Interventions

subcutaneous indwelling PROCEDURE

vacuum drainage is indwelled in subcutaneous layer

Also known as: hemovac

subcutaneous group

intraarticular indwelling PROCEDURE

vacuum drainage is indwelled in intraarticular space

Also known as: hemovac

intraarticular group

Eligibility Criteria

• Age: 54 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary osteoarthritis
• primary total knee arthroplasty
• Signed written informed consent
• Spinal/epidural anesthesia

You may not qualify if:

• Patients with coagulation disorders
• Revision total knee arthroplasty
• Simultaneous bilateral total knee arthroplasty
• Diagnosis other than primary osteoarthritis
• Patients refusing consents

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Joint Reconstruction Center, Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tae Kyun Kim, MD, PhD

  Joint Recontruction Center, Seoul National University Bundang hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: June 9, 2009
• Study Start: May 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: June 9, 2009

Record last verified: 2009-06

Locations

KR (1)