Knee ReplacementNCT04016285
Total Knee Replacement With Tourniquet or Aquamantys
A study testing Aquamantys and Tourniquet in people with Knee Replacement, run by Stephen Duncan at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Replacement
- What is being tested?
- Aquamantys and Tourniquet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 18 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- primary total knee arthroplasty
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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®).
- Conditions
- Knee Replacement
- Being tested
- Aquamantys, Tourniquet
- Keywords
- Tourniquet, Aquamantys, Arthroplasty, Total Knee, Standard of Care Tourniquet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquamantysDevice
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.
TourniquetDevice
Standard of care for reducing bleeding during the total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Aquamantys |
| Standard of Care: Tourniquet | Active comparator | Standard of care for reducing bleeding during the total knee arthroplasty Receives: Device: Tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start15 Jan 2019
- Primary completion7 Feb 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen Duncan
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Stephen Duncan, University of Kentucky
- Investigators
- Stephen Duncan, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016285
- Sponsor's protocol ID
- 47988
- Status last verified
- Apr 2024
- First submitted
- 14 Jun 2019
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not have permission to share the IPD
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.
PubMed 33316105
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04016285
- Acronym / sponsor ID
- 47988
- Conditions
- Knee Replacement
- Keywords
- Tourniquet, Aquamantys, Arthroplasty, Total Knee, Standard of Care Tourniquet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Stephen DuncanUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Posted 18 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquamantys | Experimental | Device: AquamantysThe 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 | Device: TourniquetStandard of care for reducing bleeding during the total knee arthroplasty |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary total knee arthroplasty
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AquamantysThe 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 |
| TourniquetStandard of care for reducing bleeding during the total knee arthroplasty | Device | Standard of Care: Tourniquet |
Primary outcome
Isometric Quadriceps Strength
Time frame: 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.
7 secondary outcomes
Pain (VAS)
Time frame: Preoperative, 2 weeks, 6 weeks, 12 weeks
Knee Osteoarthritis (KOOS,JR)
Time frame: 2 weeks post-op, 6 weeks post-op
Emotional Health (VR-12 MCS)
Time frame: Preoperative
Knee Function Questionnaire
Time frame: Preoperative, 2 weeks, 6 weeks, 12 weeks
Sit to Stand Test
Time frame: 6 weeks, 12 weeks
Opioid Use
Time frame: Preoperative, 2 weeks, 6 weeks, 12 weeks
Isometric Quadriceps Strength
Time frame: 6 weeks and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33316105Ahmed 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.
- Individual participant dataSharing planned: No. We do not have permission to share the IPD
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Chronic Post-surgical Pain, Chronic Post Operative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Duncan, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquamantys and Tourniquet in people with Knee Replacement, run by Stephen Duncan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric Quadriceps Strength (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04016285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.