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Reinflation After Early Tourniquet Release in Total Knee Arthroplasty

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Reinflation after early tourniquet deflation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Total knee arthroplasty, Tourniquet, Early release, Reinflation

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of primary osteoarthritis of the knee
  • Scheduled for elective total knee arthroplasty
  • Written signed consent

Exclusion Criteria:

  • Revision TKA
  • Diagnosis other than primary osteoarthritis
  • Intra-articular indwelling drainage
  • Refusing participate

Sites / Locations

  • Joint Reconstruction Center, Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reinflation after early deflation

No reinflation after early deflation

Arm Description

The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled (Reinflation after early tourniquet deflation).

The tourniquet is released after cement implant fixation, and remained deflated without reinflation, even after hemostasis.

Outcomes

Primary Outcome Measures

Operation time
Total time between initial skin incision and wound closure

Secondary Outcome Measures

Tourniquet time
Total time of tourniquet-use during the operation which defined from skin incision to the wound closure
Difficulty of the operation
Measured by the number of operative field clearance using gauze to make the remained procedure convenient
Incidence of transfusion
The incidence of allogenic or autologous (preoperative autologous blood donation) transfusion after surgery due to significant hemoglobin drop within 2weeks after surgery
Wound complications
wound complications evaluated on the 2nd and 14th day after surgery, such as ecchymosis, subcutaneous hematoma, hemarthrosis, and oozing
Thigh complications
Thigh complication due to the tourniquet, such as ecchymosis, skin bullae, and skin necrosis around the area of tourniquet application
Venous thromboembolism
symptomatic deep vein thrombosis and pulmonary embolism, detected within 2weeks after surgery
Postoperative pain (VAS)
An independent investigator who was blinded to randomization assessed knee and thigh pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain) on the 2nd and 5th day after surgery.
More painful site
An independent investigator who was blinded to randomization assessed the more painful site either knee (operation site) or thigh (tourniquet application site) on the 2nd and 5th day after surgery.
More painful side in SBTKA
An independent investigator who was blinded to randomization assessed the more painful side in patients undergoing simultaneous bilateral TKA (SBTKA), whose each knee will be allocated into experimental and control group, respectively.
Amount of drainage
Total amount of subcutaneous indwelled drainage before removal of it.
Hemoglobin drop on the 2nd day after surgery
The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 2nd day from the preoperative value
Hemoglobin drop on the 5th day after surgery
The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 5th day from the preoperative value

Full Information

First Posted
February 20, 2013
Last Updated
May 18, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01832272
Brief Title
Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
Official Title
The Effects of Tourniquet Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is aimed to determine the efficacy and the safety of the tourniquet reinflation after early tourniquet release in total knee arthroplasty, compared to the method of early deflation without reinflation. The investigators hypothesized that the reinflation after early release of the tourniquet would be effective in terms of improved visualization of the surgical field and decreased operation time and blood loss, whereas it would increase tourniquet-related complication due to longer tourniquet-use time.
Detailed Description
Total knee arthroplasty(TKA) is mostly performed with tourniquet applied, because it allows decreased intraoperative blood loss, better visualization of surgical field and better cement fixation of the implants, compared to the TKA without using tourniquet. However, there remains a controversy about the timing of tourniquet release, so the tourniquet may be unreleased throughout the whole operation time or released early just after cement fixation of the implants, atc. Early tourniquet release is generally aimed to control hidden arterial bleeding which would not be revealed if the tourniquet was unreleased. This method was reported to reduce arterial bleeding and its related complications, but it was also known that increase intraoperative bleeding, incidence of transfusion, and operation time. On the other hand, late tourniquet release, which the tourniquet is unreleased until the wound is closed, is reported to increase tourniquet-use time and related complications owing to longer tourniquet time, although it gives shorter operation time. The investigators have been used a way of reinflation of tourniquet after early release, once the arterial bleeding was controlled sufficiently, to balance the advantages and disadvantages of the early tourniquet release. The investigators were able to control arterial bleeding during the time the tourniquet was released, and the remained procedures were performed conveniently with good visualization of the surgical field after the tourniquet was reinflated again. However, there was no previous studies about the efficacy and the safety of the way of reinflation after early release of the tourniquet in the literature. Therefore, the investigators ask in this study whether the reinflation after early tourniquet release has advantages over the method of early tourniquet release without reinflation, in terms of efficacy and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Knee, Total knee arthroplasty, Tourniquet, Early release, Reinflation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reinflation after early deflation
Arm Type
Experimental
Arm Description
The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled (Reinflation after early tourniquet deflation).
Arm Title
No reinflation after early deflation
Arm Type
No Intervention
Arm Description
The tourniquet is released after cement implant fixation, and remained deflated without reinflation, even after hemostasis.
Intervention Type
Procedure
Intervention Name(s)
Reinflation after early tourniquet deflation
Other Intervention Name(s)
Reinflation after early tourniquet release
Intervention Description
The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled
Primary Outcome Measure Information:
Title
Operation time
Description
Total time between initial skin incision and wound closure
Time Frame
from skin incision to wound closure
Secondary Outcome Measure Information:
Title
Tourniquet time
Description
Total time of tourniquet-use during the operation which defined from skin incision to the wound closure
Time Frame
total sum of time between inflation and deflation of tourniquet
Title
Difficulty of the operation
Description
Measured by the number of operative field clearance using gauze to make the remained procedure convenient
Time Frame
from skin incision to wound closure
Title
Incidence of transfusion
Description
The incidence of allogenic or autologous (preoperative autologous blood donation) transfusion after surgery due to significant hemoglobin drop within 2weeks after surgery
Time Frame
within 2weeks after surgery
Title
Wound complications
Description
wound complications evaluated on the 2nd and 14th day after surgery, such as ecchymosis, subcutaneous hematoma, hemarthrosis, and oozing
Time Frame
on the 2nd and 14th day after surgery
Title
Thigh complications
Description
Thigh complication due to the tourniquet, such as ecchymosis, skin bullae, and skin necrosis around the area of tourniquet application
Time Frame
within 2 weeks
Title
Venous thromboembolism
Description
symptomatic deep vein thrombosis and pulmonary embolism, detected within 2weeks after surgery
Time Frame
within 2 weeks
Title
Postoperative pain (VAS)
Description
An independent investigator who was blinded to randomization assessed knee and thigh pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain) on the 2nd and 5th day after surgery.
Time Frame
on the 2nd and 5th day after surgery.
Title
More painful site
Description
An independent investigator who was blinded to randomization assessed the more painful site either knee (operation site) or thigh (tourniquet application site) on the 2nd and 5th day after surgery.
Time Frame
on the 2nd and 5th day after surgery
Title
More painful side in SBTKA
Description
An independent investigator who was blinded to randomization assessed the more painful side in patients undergoing simultaneous bilateral TKA (SBTKA), whose each knee will be allocated into experimental and control group, respectively.
Time Frame
on the 2nd and 5th day after surgery.
Title
Amount of drainage
Description
Total amount of subcutaneous indwelled drainage before removal of it.
Time Frame
Until the drainage removal, average of 1 to 2 days after surgery
Title
Hemoglobin drop on the 2nd day after surgery
Description
The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 2nd day from the preoperative value
Time Frame
On the 2nd day after surgery
Title
Hemoglobin drop on the 5th day after surgery
Description
The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 5th day from the preoperative value
Time Frame
On the 5th day after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of primary osteoarthritis of the knee Scheduled for elective total knee arthroplasty Written signed consent Exclusion Criteria: Revision TKA Diagnosis other than primary osteoarthritis Intra-articular indwelling drainage Refusing participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae Kyun Kim, MD, PhD
Phone
82-31-787-7196
Email
osktk@snubh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae Kyun Kim, MD, PhD
Organizational Affiliation
Joint Reconstruction Center, Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joint Reconstruction Center, Seoul National University Bundang Hospital
City
Seongnam-Si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Kyun Kim, MD, PhD
Phone
82-31-787-7196
Email
osktk@snubh.org

12. IPD Sharing Statement

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Reinflation After Early Tourniquet Release in Total Knee Arthroplasty

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