Clinical trial NCT04016285: Total Knee Replacement With Tourniquet or Aquamantys
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Replacement
Keywords: Tourniquet
Aquamantys
Arthroplasty
Total Knee
Standard of Care Tourniquet
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2019-07-11
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®).


Eligibility criteria: 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.

Primary outcomes:
measure: Isometric Quadriceps Strength
timeFrame: 2 weeks
Secondary outcomes:
measure: Pain (VAS)
timeFrame: Preoperative, 2 weeks, 6 weeks, 12 weeks
measure: Knee Osteoarthritis (KOOS,JR)
timeFrame: 2 weeks post-op, 6 weeks post-op
measure: Emotional Health (VR-12 MCS)
timeFrame: Preoperative
measure: Knee Function Questionnaire
timeFrame: Preoperative, 2 weeks, 6 weeks, 12 weeks
measure: Sit to Stand Test
timeFrame: 6 weeks, 12 weeks
measure: Opioid Use
timeFrame: Preoperative, 2 weeks, 6 weeks, 12 weeks
measure: Isometric Quadriceps Strength
timeFrame: 6 weeks and 12 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentcuky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Stephen Duncan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.