Total Knee Replacement With Tourniquet or Aquamantys

Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016285
• Other study ID #: 47988
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: April 18, 2023

Study information

• Verified date: April 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: April 18, 2023
• Est. primary completion date: February 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Replacement

Intervention

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.
• Tourniquet
Standard of care for reducing bleeding during the total knee arthroplasty

Locations

Country	Name	City	State
United States	University of Kentcuky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Stephen Duncan	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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