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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aquamantys | Experimental | 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: Tourniquet | Active Comparator | Standard of care for reducing bleeding during the total knee arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquamantys | Device | 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. |
| 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 |
| 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 |
| Knee Osteoarthritis (KOOS,JR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Duncan, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentcuky | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33316105 | Derived | 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. |
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We do not have permission to share the IPD
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population differs from the total enrollment of 73 because seven participants initially consented for surgery ultimately did not progress to that point.
Additionally, this number is greater than the 58 documented as completing the study. This was due to high turnover in research staff during the COVID-19 pandemic, which resulted in no outcome data being collected for eight participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Nm/kg | 2 weeks | Lower Extremities | Lower Extremities |
Subjects were monitored for adverse events from the time of surgery for a total of 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Limitations encountered in this study include loss to follow up prior to subjects undergoing surgery, impacts to clinical workflow stemming from the COVID-19 pandemic, high staff turnover and subsequent impacts on data collection procedures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen Duncan | University of Kentucky Department of Orthopaedic Surgery & Sports Medicine | 859-218-3084 | stephen.duncan@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2023 | Jan 24, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 2, 2019 | Jan 24, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014111 | Tourniquets |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Tourniquet | Device | Standard of care for reducing bleeding during the total knee arthroplasty |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index, Categorical | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
| OG001 | 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. |
|
|
| 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. | 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. | Posted | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | 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. | 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. | Posted | 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. | 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. | Posted | 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. | 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. | Posted | 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). | 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. | Posted | 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. | 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. | Posted | 6 weeks and 12 weeks |
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| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | 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. | 0 | 32 | 0 | 32 | 0 | 32 |
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