REAL INTELLIGENCE Tensioner for Arthroplasty

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Memorial Medical Center, Ashland, WI
Arthroplasty+2 More
REAL INTELLIGENCE Tensioner - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Study to Evaluate the REAL Intelligence Tensioner Accessory in Robotic Total Knee Arthroplasty Procedures

See full description

Eligible Conditions

  • Arthroplasty
  • Knee
  • Replacement

Treatment Effectiveness

Study Objectives

This trial is evaluating whether REAL INTELLIGENCE Tensioner will improve 1 primary outcome, 3 secondary outcomes, and 1 other outcome in patients with Arthroplasty. Measurement will happen over the course of During surgical procedure.

12 months
Quality of Life: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) at 12 months
During surgical procedure
Medial-to-lateral balance measurements at 0/10°, 30°, 60°, and 90° flexion.
Month 12
2011 Knee Society Score (KSS)
Quality of Life (EQ-5D-5L Index score)
Month 6
Quality of Life: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) pre-operative, 6 weeks, and 6 months

Trial Safety

Trial Design

1 Treatment Group

CORI Tensioner
1 of 1
Experimental Treatment

This trial requires 80 total participants across 1 different treatment group

This trial involves a single treatment. REAL INTELLIGENCE Tensioner 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.

CORI Tensioner
Device
Subjects having a robotic TKA procedure with the CORI Surgical System including the use of the REAL INTELLIGENCE Tensioner accessory.

Trial Logistics

Trial Timeline

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

Closest Location

Memorial Medical Center - Ashland, WI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Corrects a functional deformity Correction of a functional deformity may require surgery. show original
The text implies that there are fractures that are too difficult to manage using other techniques, and that this new technique is required to treat them. show original
This subject is a suitable candidate for the CORI Surgical System. show original
, is the most common type of arthritis show original
The person receiving the information must consent in writing to the disclosure of the information. show original
I am 18 years old or older. show original
I am willing and able to make all required study visits. show original
by the researcher The individual was able to follow the researcher's instructions and was deemed capable of completing the KSS and EQ-5D-5L questionnaires. show original
is a type of arthritis that affects the joints show original
Avascular necrosis

Patient Q&A Section

What are the common side effects of real intelligence tensioner?

"Based on self-reported adverse events, this therapy is well tolerated in real intelligence tensioners, with no serious adverse events reported in more than 12% of treated patients." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in real intelligence tensioner for therapeutic use?

"In the late 1980s and early 1990s, NTT (PSTO, Russia) and Siemens (Germany) developed an experimental real intelligence tensioner for therapeutic applications. Both groups of research and therapy products could not find market." - Anonymous Online Contributor

Unverified Answer

What are common treatments for replacement?

"Replacement therapy is rarely used for people with diabetes and no other diseases. A survey of people with diabetes from two primary care clinics found that only a small number received replacements or artificial limbs. There is a paucity of information about alternatives to replace." - Anonymous Online Contributor

Unverified Answer

What are the signs of replacement?

"A key sign is enlargement of the urinary bladder (>20% of normal adult volume), which can cause low back pain and symptoms of obstructed defaecation." - Anonymous Online Contributor

Unverified Answer

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

"We found that the total number of primary replacement surgeries in 2009 was approximately 5,100 per 100,000 inhabitant-years. In 2007 and 2009, the number of total replacement surgeries was approximately 4,700 per 100,000 inhabitant-years. In 2010 there was a slight increase in the mean number of surgeries that year compared with 2007 (by about 5.5 percent per 100,000 inhabitant-years), although it was a relatively small difference when compared with the number of total replacements. Thus, there has been a reduction of the annual replacement rate of total replacements in the United States since 1998." - Anonymous Online Contributor

Unverified Answer

What causes replacement?

"The first two thirds of life in a man may be a good age for a replacement of a lower urinary tract procedure. Urinary tract symptoms appear at earlier ages in men with more than two urinary tract replacements." - Anonymous Online Contributor

Unverified Answer

Can replacement be cured?

"There is a large variance in the experience of subjects with respect to the outcome of the procedure. A large quantity of subjects (around two thirds of subjects) are optimistic with regard to the result. This has not been taken into account by the authorities in charge of selecting a surgery model. Replacement should be considered as a'stopgap' procedure which may be considered when more permanent solutions have failed to work." - Anonymous Online Contributor

Unverified Answer

What is replacement?

"Replacement may be used in a variety of conditions including [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis), osteoporotic fractures, and arthritis. However, replacement is usually taken as an alternative to nonnarcotic medications that are more expensive but less effective. Replacement may offer no advantages over medications, but it may have an adverse impact on quality of life. It also may not be a cost-effective strategy." - Anonymous Online Contributor

Unverified Answer

Is real intelligence tensioner typically used in combination with any other treatments?

"There was not enough evidence to conclude that, in any one clinical setting, either IA technique can prevent the tensioners. However, IA techniques might be usefully combined with other treatment, such as, surgery, antibiotics, or physiotherapy to help prevent the tensioners. It is best to follow up with your rehabilitation treatment and regular exercises." - Anonymous Online Contributor

Unverified Answer

Is real intelligence tensioner safe for people?

"The tensioner was safe and effective in inducing rapid and large changes in IQ score that would require adjustment. The tensioner provides a useful tool in study design and for assessing real IQ change." - Anonymous Online Contributor

Unverified Answer

What is real intelligence tensioner?

"The findings support the need to assess [intelligence tensioner beliefs and expectations on a periodic basis, during, at least the first year, after the commencement of therapy with antidepressants] during treatments as an integral part of the treatment package to be administered with depressive patients." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of replacement?

"Replacement of allografts is the main cause of allograft rejection from a population cohort study of a single-center. The primary cause appears to be recipient-specific cellular immunity." - 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.
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