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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04016285
Enrollment
73
Registered
2019-07-11
Start date
2019-01-15
Completion date
2023-04-18
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Replacement

Keywords

Tourniquet, Aquamantys, Arthroplasty, Total Knee, Standard of Care Tourniquet

Brief 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®).

Interventions

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.

DEVICETourniquet

Standard of care for reducing bleeding during the total knee arthroplasty

Sponsors

Medtronic
CollaboratorINDUSTRY
Stephen Duncan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Isometric Quadriceps Strength2 weeksThe 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.

Secondary

MeasureTime frameDescription
Knee Osteoarthritis (KOOS,JR)2 weeks post-op, 6 weeks post-opKnee 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.
Emotional Health (VR-12 MCS)PreoperativeThe 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.
Knee Function QuestionnairePreoperative, 2 weeks, 6 weeks, 12 weeksThe 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.
Pain (VAS)Preoperative, 2 weeks, 6 weeks, 12 weeksPain 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.
Opioid UsePreoperative, 2 weeks, 6 weeks, 12 weeksOpioid 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).
Isometric Quadriceps Strength6 weeks and 12 weeksStrength 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.
Sit to Stand Test6 weeks, 12 weeksThis 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.

Countries

United States

Participant flow

Recruitment details

Patients at a large, academic hospital clinic seen in the practice of an early-career, fellowship-trained arthroplasty surgeon were screened for enrollment from 2019-2022. Patients between 18 and 85 years of age being scheduled for unilateral, elective primary TKA, and competent to provide informed consent and participate in the required testing and questionnaires at follow-up appointments were invited. Patients undergoing revision TKA or unicompartmental arthroplasty were excluded.

Participants by arm

ArmCount
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. Subjects in this arm received total knee arthroplasty with the use of the Aquamantys bipolar sealer to aid in hemostasis.
34
Tourniquet
Pneumatic tourniquet use is a common practice for reducing bleeding during total knee arthroplasty Subjects in this arm received total knee arthroplasty with the use of a pneumatic tourniquet to aid in hemostasis.
32
Total66

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDid not progress to surgery25
Overall StudyFailed to collect outcome data53

Baseline characteristics

CharacteristicAquamantysTourniquetTotal
Age, Customized
44-54 years
4 Participants7 Participants11 Participants
Age, Customized
55-64 years
17 Participants13 Participants30 Participants
Age, Customized
65-74 years
9 Participants9 Participants18 Participants
Age, Customized
75+ years
4 Participants3 Participants7 Participants
Body Mass Index, Categorical
18.5-24.9 kg/m^2
3 Participants2 Participants5 Participants
Body Mass Index, Categorical
<18.5 kg/m^2
1 Participants0 Participants1 Participants
Body Mass Index, Categorical
25-29.9 kg/m^2
17 Participants18 Participants35 Participants
Body Mass Index, Categorical
30-39.9 kg/m^2
6 Participants5 Participants11 Participants
Body Mass Index, Categorical
40+ kg/m^2
7 Participants7 Participants14 Participants
Race/Ethnicity, Customized
Asian
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Black, Non-Hispanic
5 Participants1 Participants6 Participants
Race/Ethnicity, Customized
Hispanic
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Other
3 Participants0 Participants3 Participants
Race/Ethnicity, Customized
White, Non-Hispanic
25 Participants30 Participants55 Participants
Sex/Gender, Customized
Man
13 Participants15 Participants28 Participants
Sex/Gender, Customized
Woman
21 Participants17 Participants38 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 340 / 32
other
Total, other adverse events
0 / 340 / 32
serious
Total, serious adverse events
0 / 340 / 32

Outcome results

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.

Time frame: 2 weeks

Population: The numbers of participants listed in this section do not match the overall number of participants listed as completing the study. This is due to lapses in data collection procedures that were brought on by high rates of research staff turnover during the COVID-19 pandemic. The numbers here reflect the number of participants in each group for whom isometric quadriceps strength was collected at two weeks in both the operative extremity and the non-operative extremity.

ArmMeasureValue (MEAN)Dispersion
AquamantysIsometric Quadriceps Strength11.58 Nm/kgStandard Deviation 7.87
TourniquetIsometric Quadriceps Strength9.60 Nm/kgStandard Deviation 3.33
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.

Time frame: Preoperative

Population: The difficulty encountered in retaining research staff, in addition to the constraints associated with the COVID-19 pandemic, led to inability to collect this data point.

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.

Time frame: 6 weeks and 12 weeks

Population: The difficulty encountered in retaining research staff, in addition to the constraints associated with the COVID-19 pandemic, led to inability to collect this data point.

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.

Time frame: Preoperative, 2 weeks, 6 weeks, 12 weeks

Population: The difficulty encountered in retaining research staff, in addition to the constraints associated with the COVID-19 pandemic, led to inability to collect this data point.

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.

Time frame: 2 weeks post-op, 6 weeks post-op

Population: This number differs from that listed in the primary outcome as this was a passive, participant driven outcome measure as opposed to our primary outcome, which required the presence of research staff at clinic follow up.~It was our original intention to collect this information at 12 weeks following surgery. However, the increased pressure to reduce in-person visits during the COVID-19 pandemic necessitated a temporary change in practice and made collecting this data at 12 weeks unfeasible.

ArmMeasureGroupValue (MEAN)Dispersion
AquamantysKnee Osteoarthritis (KOOS,JR)Two Week KOOS, JR Score13 Score on a scaleStandard Deviation 2.2
AquamantysKnee Osteoarthritis (KOOS,JR)Six Week KOOS, JR Score16 Score on a scaleStandard Deviation 2.1
TourniquetKnee Osteoarthritis (KOOS,JR)Two Week KOOS, JR Score10 Score on a scaleStandard Deviation 1.4
TourniquetKnee Osteoarthritis (KOOS,JR)Six Week KOOS, JR Score17 Score on a scaleStandard Deviation 1.8
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).

Time frame: Preoperative, 2 weeks, 6 weeks, 12 weeks

Population: The difficulty encountered in retaining research staff, in addition to the constraints associated with the COVID-19 pandemic, led to inability to collect this data point.

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.

Time frame: Preoperative, 2 weeks, 6 weeks, 12 weeks

Population: The difficulty encountered in retaining research staff, in addition to the constraints associated with the COVID-19 pandemic, led to inability to collect this data point.

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.

Time frame: 6 weeks, 12 weeks

Population: The difficulty encountered in retaining research staff, in addition to the constraints associated with the COVID-19 pandemic, led to inability to collect this data point.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026