N/A
Completed N=73
Total Knee Replacement With Tourniquet or Aquamantys
Knee Replacement
Source: ClinicalTrials.gov NCT04016285 ↗
Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Isometric Quadriceps Strength — 11.58; 9.60 Nm/kg
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®).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Isometric Quadriceps Strength |
— | — |
| SECONDARY Pain (VAS) |
— | — |
| SECONDARY Knee Osteoarthritis (KOOS,JR) |
13; 10; 16; 17 | — |
| SECONDARY Emotional Health (VR-12 MCS) |
— | — |
| SECONDARY Knee Function Questionnaire |
— | — |
| SECONDARY Sit to Stand Test |
— | — |
| SECONDARY Opioid Use |
— | — |
| SECONDARY Isometric Quadriceps Strength |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT04016285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.