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Reinflation After Early Tourniquet Release in Total Knee Arthroplasty

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis, Knee

Intervention: Reinflation after early tourniquet deflation (Procedure)

Phase: Phase 4

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Tae Kyun Kim, MD, PhD, Principal Investigator, Affiliation: Joint Reconstruction Center, Seoul National University Bundang Hospital

Overall contact:
Tae Kyun Kim, MD, PhD, Phone: 82-31-787-7196, Email: osktk@snubh.org

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.

Clinical Details

Official title: The Effects of Tourniquet Reinflation After Early Tourniquet Release in Total Knee Arthroplasty

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Operation time

Secondary outcome:

Tourniquet time

Difficulty of the operation

Incidence of transfusion

Wound complications

Thigh complications

Venous thromboembolism

Postoperative pain (VAS)

More painful site

More painful side in SBTKA

Amount of drainage

Hemoglobin drop on the 2nd day after surgery

Hemoglobin drop on the 5th day after surgery

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.

Eligibility

Minimum age: 40 Years. Maximum age: 90 Years. Gender(s): Both.

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

Locations and Contacts

Tae Kyun Kim, MD, PhD, Phone: 82-31-787-7196, Email: osktk@snubh.org

Joint Reconstruction Center, Seoul National University Bundang Hospital, Seongnam-Si, Gyeonggi-do 463-707, Korea, Republic of; Recruiting
Tae Kyun Kim, MD, PhD, Phone: 82-31-787-7196, Email: osktk@snubh.org
Additional Information

Starting date: February 2013
Last updated: May 18, 2014

Page last updated: August 23, 2015

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