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 timeDifficulty 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
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