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CORI™ Knee Tensioner for Knee Replacement Surgery

N/A
Recruiting
Research Sponsored by Smith & Nephew, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject requires a cemented TKA as a primary indication due to any of the following conditions: Degenerative joint disease, including osteoarthritis, Rheumatoid arthritis, Avascular necrosis, Requires correction of functional deformity, Requires treatment of fractures that were unmanageable using other techniques
Subject is eighteen (18) years old or older
Must not have
Women who are pregnant, nursing, or of child-bearing potential who are not utilizing birth control measures
Subject has active infection or sepsis (treated or untreated)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operative, 6 weeks, 6 months, and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will help assess the performance of the REAL INTELLIGENCE™ Tensioner as an accessory to the CORI Surgical System for patients undergoing a robotic TKA procedure.

Who is the study for?
This trial is for adults over 18 who need a knee replacement due to conditions like osteoarthritis or rheumatoid arthritis and can follow up for one year. They must understand English, not be morbidly obese (BMI under 40), and have no active infections, severe joint diseases, or mental illness affecting compliance.
What is being tested?
The CORI™ KNEE TENSIONER's performance is being tested as an accessory to the CORI™ Surgical System during knee replacement surgeries. The study aims to assess how well it works with the surgical system in improving surgery outcomes.
What are the potential side effects?
While specific side effects are not listed for the tensioner itself, typical risks of knee surgery may include pain at the incision site, swelling, infection risk post-surgery, blood clots, stiffness in the knee joint, and possible damage to surrounding tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need a knee replacement due to arthritis, bone death, deformity, or unmanageable fractures.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, nursing, or if capable of becoming pregnant, I am using birth control.
Select...
I do not have an active infection or sepsis.
Select...
I need a complex knee replacement or revision due to a previous surgery failure.
Select...
My BMI is over 40, classifying me as morbidly obese.
Select...
I have arthritis caused by a past injury.
Select...
I need knee replacement surgery on both knees.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-operative, 6 weeks, 6 months, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operative, 6 weeks, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quality of Life: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) at 12 months
Secondary study objectives
2011 Knee Society Score (KSS)
Quality of Life (EQ-5D-5L Index score)
Quality of Life: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) pre-operative, 6 weeks, and 6 months
Other study objectives
Medial-to-lateral balance measurements at 0/10°, 30°, 60°, and 90° flexion.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CORI TENSIONERExperimental Treatment1 Intervention
Subjects having a robotic TKA procedure with the CORI Surgical System, including the use of the CORI™ KNEE TENSIONER accessory.

Find a Location

Who is running the clinical trial?

Smith & Nephew, Inc.Lead Sponsor
169 Previous Clinical Trials
22,418 Total Patients Enrolled
Kelli ArmstrongStudy ChairSmith & Nephew, Inc.
2 Previous Clinical Trials
248 Total Patients Enrolled

Media Library

CORI TENSIONER Clinical Trial Eligibility Overview. Trial Name: NCT04849884 — N/A
Joint Replacement Surgery Research Study Groups: CORI TENSIONER
Joint Replacement Surgery Clinical Trial 2023: CORI TENSIONER Highlights & Side Effects. Trial Name: NCT04849884 — N/A
CORI TENSIONER 2023 Treatment Timeline for Medical Study. Trial Name: NCT04849884 — N/A
~12 spots leftby May 2025
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