Total Knee Replacement With Tourniquet or Aquamantys

Stephen Duncan

Status: Completed

Conditions: Knee Replacement

Treatments: Device: Tourniquet; Device: Aquamantys

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04016285

47988

Details and patient eligibility

About

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®).

Enrollment: 73 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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73 participants in 2 patient groups

Aquamantys

Experimental group

Description:

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.

Treatment:

Device: Aquamantys

Standard of Care: Tourniquet

Active Comparator group

Description:

Standard of care for reducing bleeding during the total knee arthroplasty

Treatment:

Device: Tourniquet