Knee Replacement
Conditions
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.
Standard of care for reducing bleeding during the total knee arthroplasty
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Isometric Quadriceps Strength | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Osteoarthritis (KOOS,JR) | 2 weeks post-op, 6 weeks post-op | 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. |
| Emotional Health (VR-12 MCS) | Preoperative | 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. |
| Knee Function Questionnaire | Preoperative, 2 weeks, 6 weeks, 12 weeks | 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. |
| Pain (VAS) | Preoperative, 2 weeks, 6 weeks, 12 weeks | 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. |
| Opioid Use | Preoperative, 2 weeks, 6 weeks, 12 weeks | 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). |
| Isometric Quadriceps Strength | 6 weeks and 12 weeks | 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. |
| Sit to Stand Test | 6 weeks, 12 weeks | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not progress to surgery | 2 | 5 |
| Overall Study | Failed to collect outcome data | 5 | 3 |
Baseline characteristics
| Characteristic | Aquamantys | Tourniquet | Total |
|---|---|---|---|
| Age, Customized 44-54 years | 4 Participants | 7 Participants | 11 Participants |
| Age, Customized 55-64 years | 17 Participants | 13 Participants | 30 Participants |
| Age, Customized 65-74 years | 9 Participants | 9 Participants | 18 Participants |
| Age, Customized 75+ years | 4 Participants | 3 Participants | 7 Participants |
| Body Mass Index, Categorical 18.5-24.9 kg/m^2 | 3 Participants | 2 Participants | 5 Participants |
| Body Mass Index, Categorical <18.5 kg/m^2 | 1 Participants | 0 Participants | 1 Participants |
| Body Mass Index, Categorical 25-29.9 kg/m^2 | 17 Participants | 18 Participants | 35 Participants |
| Body Mass Index, Categorical 30-39.9 kg/m^2 | 6 Participants | 5 Participants | 11 Participants |
| Body Mass Index, Categorical 40+ kg/m^2 | 7 Participants | 7 Participants | 14 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black, Non-Hispanic | 5 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White, Non-Hispanic | 25 Participants | 30 Participants | 55 Participants |
| Sex/Gender, Customized Man | 13 Participants | 15 Participants | 28 Participants |
| Sex/Gender, Customized Woman | 21 Participants | 17 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 32 |
| other Total, other adverse events | 0 / 34 | 0 / 32 |
| serious Total, serious adverse events | 0 / 34 | 0 / 32 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aquamantys | Isometric Quadriceps Strength | 11.58 Nm/kg | Standard Deviation 7.87 |
| Tourniquet | Isometric Quadriceps Strength | 9.60 Nm/kg | Standard Deviation 3.33 |
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.
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.
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.
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aquamantys | Knee Osteoarthritis (KOOS,JR) | Two Week KOOS, JR Score | 13 Score on a scale | Standard Deviation 2.2 |
| Aquamantys | Knee Osteoarthritis (KOOS,JR) | Six Week KOOS, JR Score | 16 Score on a scale | Standard Deviation 2.1 |
| Tourniquet | Knee Osteoarthritis (KOOS,JR) | Two Week KOOS, JR Score | 10 Score on a scale | Standard Deviation 1.4 |
| Tourniquet | Knee Osteoarthritis (KOOS,JR) | Six Week KOOS, JR Score | 17 Score on a scale | Standard Deviation 1.8 |
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.
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.
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.