Clinical trial NCT00916331: Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty
Official title: Subcutaneous Indwelling of Vacuum Drainage in Total Knee Arthroplasty: Prospective Randomized Comparisons With Intraarticular Indwelling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Keywords: total knee replacement arthroplasty
subcutaneous indwelling
blood loss
complications
functional status
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-06-09
Enrollment: 111
Sex: ALL
Minimum age (years): 54
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: blood parameters by which we can estimate blood loss , such as drained blood volume, hemoglobin and hemoglobin drop
timeFrame: 24 hours after operation
Secondary outcomes:
measure: transfusion
timeFrame: during hospital stay
measure: wound problem
timeFrame: during hospital stay
measure: hypotension episode
timeFrame: during hospital stay
measure: functional outcome (ROM, AKS Knee score, WOMAC score, SF-36 score)
timeFrame: preoperative & postoperative 1 year
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Joint Reconstruction Center, Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Joint Recontruction Center, Seoul National University Bundang hospital
name: Tae Kyun Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: