Aquamantys for Replacement, Knee

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Kentcuky, Lexington, KY
Replacement, Knee
Aquamantys - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Total Knee Replacement With Tourniquet or Aquamantys

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Aquamantys will improve 7 secondary outcomes in patients with Replacement, Knee. Measurement will happen over the course of 6 weeks and 12 weeks.

Week 12
Isometric quadriceps strength
6 weeks, 12 weeks
Sit to stand test
Preoperative
Emotional Health (VR-12 MCS)
Week 12
Knee Osteoarthritis (KOOS,JR)
Knee function questionnaire
Opioid Use
Pain (VAS)

Trial Safety

Trial Design

2 Treatment Groups

Standard of Care: Tourniquet
1 of 2
Aquamantys
1 of 2
Active Control
Experimental Treatment

This trial requires 70 total participants across 2 different treatment groups

This trial involves 2 different treatments. Aquamantys is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

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.
Standard of Care: Tourniquet
Device
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
~200

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: preoperative, 2 weeks, 6 weeks, 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly preoperative, 2 weeks, 6 weeks, 12 weeks for reporting.

Closest Location

University of Kentcuky - Lexington, KY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
primary total knee arthroplasty

Patient Q&A Section

What are the signs of replacement, knee?

"Replacement knee surgery and a number of health problems (pain, chronic fatigue/mood impairment/depression) are common. Given the lack of reliable information on preoperative risk, the best strategy is not to consider replacing the knee if there is no known underlying medical cause, or to consider replacement only after a multidisciplinary approach has been established." - Anonymous Online Contributor

Unverified Answer

How many people get replacement, knee a year in the United States?

"Over one in five American adults had one or more [conditions requiring replacement or reconstruction of their lower extremities] within the previous year. The annual rate may be even higher for children residing in low-income states or those with one or both parents employed in education. Such alarming findings imply an enduring problem of low rates for specific conditions." - Anonymous Online Contributor

Unverified Answer

Can replacement, knee be cured?

"In contrast to total knee arthroplasty, TKA in the United Kingdom has a more limited role in treating osteoarthritis of the knee. Moreover, the evidence for a lower revision rate after TKA at six years is equivocal." - Anonymous Online Contributor

Unverified Answer

What is replacement, knee?

"There are many different types of replacements: arthroplasty, autograft, allograft, or composite prosthesis, with or without the use of supplemental material on an anatomic geometry that is designed to restore a comfortable range of motion. Each of these types of replacements has its own advantages and disadvantages. All can be successful for a variety of indications, including rheumatoid arthritis. Most studies have found the same outcome in terms of function." - Anonymous Online Contributor

Unverified Answer

What causes replacement, knee?

"Knee joint replacement surgery is effective at improving functions and quality of life in both active and inactive patients with knee OA. This is attributable, at least in part, to the increased motion available for activities of daily living and in terms of function. The majority of patients perceive improvement in knee pain after surgery and improvements in quality of life. These improvements are maintained for a number of years post-surgery and are largely independent of the magnitude of changes in knee joint space." - Anonymous Online Contributor

Unverified Answer

What are common treatments for replacement, knee?

"People with knee replacement often receive some pain medication as well as physical therapy. In the case of replacement, the type of metal (polyether acetal, polyether propylene, polyether block copolymer) is important because of the stiffness. The primary therapy is often a knee brace or a removable knee brace. When used for the first 6 weeks after surgery, the brace alleviates pain and allows for the patient to gradually start physical therapy exercises. If tolerated by the patient, after 6 weeks, the brace can be removed, and physical therapy exercises can be resumed. If the discomfort from wearing a brace remains, custom-fitted knee braces can be used indefinitely." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets replacement, knee?

"Results from a recent paper provides an overview of the medical literature on the current practices of knee replacement in children. It also demonstrates how to use the results to guide discussion in a family planning clinic with parents of children with musculoskeletal conditions." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for replacement, knee?

"[Patients with an indication for resurfacing of a mobile-bearing total knee have a statistically significant higher probability of participation in clinical trials compared to those patients with an indication for total knee arthroplasty." - Anonymous Online Contributor

Unverified Answer

Has aquamantys proven to be more effective than a placebo?

"Aquamantys was more effective than a placebo in improving pain, function, and QoL in patients who are candidates for surgery based on the clinical indication of ACI. Further studies are required to determine whether Aquamantys is more effective in other types of hip and knee arthroplasty surgery. However, aquamantys still may be helpful to select patients who are candidates for a joint replacement." - Anonymous Online Contributor

Unverified Answer

Does replacement, knee run in families?

"Although a substantial genetic component to patellofemoral osteoarthritis has been identified to date, the presence of an association between patellofemoral osteoarthritis and the patellar running style seems to be limited. Data from a recent study of our family study were similar to the ones of other family studies and the results from the population-based study published previously by Bonsall et al.(2009)." - Anonymous Online Contributor

Unverified Answer

What is aquamantys?

"Aquamantys is a popular form of medical cannabis in Switzerland. In addition to its medical value, aquamantys is also consumed in the form of tincture, syrup, and capsules. Aquamantys has the potential to produce adverse and transient side effects, which can then be alleviated by the use of medical marijuana." - Anonymous Online Contributor

Unverified Answer

Does aquamantys improve quality of life for those with replacement, knee?

"The findings from this pilot study show that aquamantys significantly improved HR-QoL in patients when used for a period of 2 months. It can therefore be safely speculated that aquamantys may prove particularly effective for the treatment of patients with chronic pain." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Replacement, Knee by sharing your contact details with the study coordinator.