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Aquamantys for Knee Replacement

N/A

Waitlist Available

Led By Stephen Duncan, MD

Research Sponsored by Stephen Duncan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperative, 2 weeks, 6 weeks, 12 weeks

Awards & highlights

Study Summary

This trial will compare two methods of total knee replacement to see if one is more effective than the other in terms of quadriceps muscle strength, pain, opioid consumption, and patient function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperative, 2 weeks, 6 weeks, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperative, 2 weeks, 6 weeks, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative, 2 weeks, 6 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Emotional Health (VR-12 MCS)

Isometric Quadriceps Strength

Knee Function Questionnaire

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AquamantysExperimental Treatment1 Intervention

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.

Group II: Standard of Care: TourniquetActive Control1 Intervention

Standard of care for reducing bleeding during the total knee arthroplasty

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aquamantys

2009

N/A

~280

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Who is running the clinical trial?

Stephen DuncanLead Sponsor

MedtronicIndustry Sponsor

607 Previous Clinical Trials

828,602 Total Patients Enrolled

Stephen Duncan, MDPrincipal Investigator - University of Kentucky

University of Kentucky Albert B. Chandler Hospital

Vanderbilt University School Of Medicine (Medical School)

1 Previous Clinical Trials

234 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any qualifications necessary to become a participant of this clinical experiment?

"To partake in this clinical trial, participants must possess a replacement knee and be between 18 to 100 years old. Currently, 70 individuals are being recruited for the study."

Answered by AI

What is the present size of this clinical trial's participant pool?

"Affirmative. According to the data posted on clinicaltrials.gov, this trial is currently recruiting patients that meet its criteria; it was initially published on August 15th 2019 and last revised on October 29th 2022. 70 individuals need to be enrolled from a single site in order for the study's objectives to be achieved."

Answered by AI

Does this experiment permit persons aged 35 and over to participate?

"This research is open to those aged 18 - 100."

Answered by AI

Is this clinical experiment actively looking for participants?

"Affirmative. The clinical trial registry on clinicaltrials.gov attests that this medical research project, which was originally announced on August 15th 2019 is currently recruiting patients. 70 individuals must be recruited from the single site to fulfil their requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Total Knee Replacement With Tourniquet or Aquamantys

Stephen Duncan 2019. "Total Knee Replacement With Tourniquet or Aquamantys". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04016285.