Reinflation After Early Tourniquet Release in Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01832272
• Other study ID #: B-1206/158-004
• Status: Recruiting
• Phase: Phase 4
• First received: February 20, 2013
• Last updated: May 18, 2014
• Start date: February 2013
• Est. completion date: January 2015

Study information

• Verified date: May 2014
• Source: Seoul National University Hospital
• Contact: Tae Kyun Kim, MD, PhD
• Phone: 82-31-787-7196
• Email: osktk[@]snubh.org
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Reinflation after early tourniquet deflation
The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled

Locations

Country	Name	City	State
Korea, Republic of	Joint Reconstruction Center, Seoul National University Bundang Hospital	Seongnam-Si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operation time	Total time between initial skin incision and wound closure	from skin incision to wound closure	No
Secondary	Tourniquet time	Total time of tourniquet-use during the operation which defined from skin incision to the wound closure	total sum of time between inflation and deflation of tourniquet	No
Secondary	Difficulty of the operation	Measured by the number of operative field clearance using gauze to make the remained procedure convenient	from skin incision to wound closure	No
Secondary	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	within 2weeks after surgery	Yes
Secondary	Wound complications	wound complications evaluated on the 2nd and 14th day after surgery, such as ecchymosis, subcutaneous hematoma, hemarthrosis, and oozing	on the 2nd and 14th day after surgery	Yes
Secondary	Thigh complications	Thigh complication due to the tourniquet, such as ecchymosis, skin bullae, and skin necrosis around the area of tourniquet application	within 2 weeks	Yes
Secondary	Venous thromboembolism	symptomatic deep vein thrombosis and pulmonary embolism, detected within 2weeks after surgery	within 2 weeks	Yes
Secondary	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.	on the 2nd and 5th day after surgery.	No
Secondary	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.	on the 2nd and 5th day after surgery	No
Secondary	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.	on the 2nd and 5th day after surgery.	No
Secondary	Amount of drainage	Total amount of subcutaneous indwelled drainage before removal of it.	Until the drainage removal, average of 1 to 2 days after surgery	Yes
Secondary	Hemoglobin drop on the 2nd day after surgery	The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 2nd day from the preoperative value	On the 2nd day after surgery	Yes
Secondary	Hemoglobin drop on the 5th day after surgery	The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 5th day from the preoperative value	On the 5th day after surgery	Yes