Total Knee Replacement With Tourniquet or Aquamantys

Comparison to Short-duration Tourniquet Total Knee Arthroplasty (TKA) With the Aquamantys® Bipolar Sealer and the Standard of Care in the Setting of Outpatient TKA: A Randomized, Double-blinded Study

The purpose of this study is to compare quadriceps muscle strength, pain, opioid consumption and patient function during the first three months after short-stay total knee replacement between patients treated with short-duration tourniquet knee replacement with the Aquamantys® bipolar sealer versus those treated with the standard of care (tourniquet used throughout the case and no Aquamantys®).

By doing this study, investigators hope to learn if short duration tourniquet knee replacement with the Aquamantys® bipolar sealer is more effective than standard of care (tourniquet used throughout the case and no Aquamantys®). The purpose of this study is to compare quadriceps muscle strength, pain, opioid consumption and patient function during the first three months after short-stay total knee replacement between patients treated with short-duration tourniquet knee replacement with the Aquamantys® bipolar sealer versus those treated with the standard of care (tourniquet used throughout the case and no Aquamantys®).

Study Overview

• Status: Completed
• Conditions: Knee Replacement
• Intervention / Treatment: Device: Aquamantys; Device: Tourniquet

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen T Duncan, MD; Phone Number: (859) 218-3131; Email: stdunc2@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentcuky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• primary total knee arthroplasty

Exclusion Criteria:

• repeat knee replacement (revision arthroplasty)
• bilateral knee replacements on the same day
• partial knee replacements
• health or social limitations that do not allow for the participant to be discharged to home on the same day or day after surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aquamantys; The Aquamantys bipolar sealer is a device used during surgery to help reduce bleeding in the joint. The system uses radiofrequency energy and sterile saline (salt water) to close small blood vessels in the knee to help reduce bleeding.	Device: Aquamantys; The Aquamantys bipolar sealer is a device used during surgery to help reduce bleeding in the joint. The system uses radiofrequency energy and sterile saline (salt water) to close small blood vessels in the knee to help reduce bleeding.
Active Comparator: Standard of Care: Tourniquet; Standard of care for reducing bleeding during the total knee arthroplasty	Device: Tourniquet; Standard of care for reducing bleeding during the total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isometric Quadriceps Strength	The participant will sit in a seated position and a stabilizing strap will be placed around the bottom of the participant's shank and attached to a hand-held dynamometer. The participant will be asked to slowly kick the foot as hard as they can into the dynamometer pad (muscle testing hardware), and force will be measured. Increased measured force indicates greater quadriceps strength. Measurements will be recorded for both the operative extremity and the non-operative extremity, and the results will be expressed as a percentage of the mean strength measured in operative extremities compared to that measured in non-operative extremities for each study group.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain (VAS)	Pain will be measured using the visual analog scale (VAS), which assess pain levels on a scale from 0-10. Lower numbers indicate less pain while higher numbers indicate more pain.	Preoperative, 2 weeks, 6 weeks, 12 weeks
Emotional Health (VR-12 MCS)	The Veterans Rand-12 Mental Component Score will be used to quantify the impact of the participants emotional health on their daily activities. The VR-12 consists of 12 questions, is scored from 0-100 with lower scores indicating that emotional health has a more dramatic impact on the participant's daily life.	Preoperative
Opioid Use	Opioid use will be assessed with a single question with a binary response (either yes the participant is taking opioid medications or no they are not).	Preoperative, 2 weeks, 6 weeks, 12 weeks
Knee Osteoarthritis (KOOS,JR)	Knee injury Osteoarthritis Outcome Score, Joint Replacement (KOOS,JR) patient-reported outcome score. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR scores are reported here in a range from 0-28 with mean and standard deviation for each group at two and six weeks post-op. Higher scores represent better perceived knee function.	2 weeks post-op, 6 weeks post-op
Knee Function Questionnaire	The knee function questionnaire is a study-specific questionnaire to assess knee problems that may affect everyday life. It consists of three questions: one about walking support, one about going up stairs and one about coming down stairs. Responses are categorical, and will be used to compare the proportion of patients in each group that can walk without a walker or cane, or navigate stairs without the use of upper body support. The knee function questionnaire is not a graded scale, but will be used to assess the proportion of each group that self-reports the ability to perform these 3 tasks at each of the study time points.	Preoperative, 2 weeks, 6 weeks, 12 weeks
Sit to Stand Test	This is a timed test used to measure mobility and function. Participants are positioned in a standard 16" office chair with their arms at their sides and back located against the back of the chair. Participants are instructed to stand and sit as quickly as possible 5 times. The test is timed using a stopwatch and the timer is stopped when the individual achieves a standing position on the 5th trial. Shorter times indicate better mobility and function.	6 weeks, 12 weeks
Isometric Quadriceps Strength	Strength will be assessed at multiple time points during the study. The participant will sit in a seated position and a stabilizing strap will be placed around the bottom of the participant's shank and attached to a hand-held dynamometer. The participant will be asked to slowly kick the foot as hard as they can into the dynamometer pad (muscle testing hardware) placed on the anterior aspect of the participant's distal tibia. One practice trial followed by 3 actual trials will be performed. The participant will receive a 30-second rest in between each trial and a 1-minute rest in between legs for each test to prevent fatigue. Increased measured force indicates greater quadriceps strength.	6 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: Stephen Duncan
• Collaborators: Medtronic
• Investigators: Principal Investigator: Stephen Duncan, MD, University of Kentucky

Publications and helpful links

General Publications

• Ahmed I, Chawla A, Underwood M, Price AJ, Metcalfe A, Hutchinson C, Warwick J, Seers K, Parsons H, Wall PD. Tourniquet use for knee replacement surgery. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012874. doi: 10.1002/14651858.CD012874.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): February 7, 2023
• Study Completion (Actual): April 18, 2023

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Arthroplasty; Tourniquet; Aquamantys; Total Knee; Standard of Care Tourniquet
• Other Study ID Numbers: 47988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not have permission to share the IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No