Total Knee Replacement With Tourniquet or Aquamantys

NCT04016285 | Completed Results FDA Device

• 1 other identifier: 47988
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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®).

Conditions

Knee Replacement

Keywords

Tourniquet; Aquamantys; Arthroplasty; Total Knee; Standard of Care Tourniquet

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Pain (VAS)

  Preoperative, 2 weeks, 6 weeks, 12 weeks

• Knee Osteoarthritis (KOOS,JR)

  2 weeks post-op, 6 weeks post-op

• Emotional Health (VR-12 MCS)

  Preoperative

• Knee Function Questionnaire

  Preoperative, 2 weeks, 6 weeks, 12 weeks

• Sit to Stand Test

  6 weeks, 12 weeks

Study Arms (2)

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.

Device: Aquamantys

Standard of Care: Tourniquet

ACTIVE COMPARATOR

Standard of care for reducing bleeding during the total knee arthroplasty

Device: Tourniquet

Interventions

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.

Aquamantys

Tourniquet DEVICE

Standard of care for reducing bleeding during the total knee arthroplasty

Standard of Care: Tourniquet

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary total knee arthroplasty

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stephen Duncan: lead
• Medtronic: collaborator

Study Sites (1)

University of Kentcuky

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

• 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.

  PMID: 33316105 DERIVED

MeSH Terms

Interventions

Tourniquets

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Stephen Duncan
• Organization: University of Kentucky Department of Orthopaedic Surgery & Sports Medicine

stephen.duncan@uky.edu

859-218-3084

Study Officials

• Stephen Duncan, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: July 11, 2019
• Study Start: January 15, 2019
• Primary Completion: February 7, 2023
• Study Completion: April 18, 2023
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)