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Robotic Surgery

Robotic-Assisted Knee Surgery for Joint Replacement

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 UKA or TKA as a primary indication that meets either criterion A or B.

A. Subject requires a cemented UKA as a primary indication due to any of the following conditions: Non-inflammatory degenerative joint disease, including osteoarthritis; Avascular necrosis; Requires correction of functional deformity; Requires treatment of fractures that were unmanageable using other techniques.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 week, 6 month and 12 months

Awards & highlights

Study Summary

This trial is being done to test the safety and effectiveness of a computer-assisted orthopedic surgical navigation and burring system (CORI Robotics) for certain types of knee surgery. 140 patients will be recruited from 4 countries to have either unicondylar knee arthroplasty (UKA) or total knee arthroplasty (TKA) surgery. The primary objective of the study is to evaluate if the CORI Robotics system helps surgeons achieve the desired post-operative leg alignment.

Who is the study for?

This trial is for adults needing primary knee replacement surgery due to conditions like osteoarthritis or bone deformities. Candidates must agree to follow-up for one year post-surgery and be able to undergo routine X-rays. Exclusions include those with previous failed surgeries, certain joint diseases, morbid obesity (BMI over 40), pregnancy, or inability to consent.Check my eligibility

What is being tested?

The study tests the CORI Robotics system in knee surgeries (UKA and TKA) across four countries. It aims to see if the robot helps surgeons align legs as planned post-operation. The trial involves 140 patients split between UKA and TKA procedures.See study design

What are the potential side effects?

While specific side effects of using CORI Robotics aren't detailed, typical risks may include infection, pain at the surgery site, swelling, stiffness in the knee joint, bleeding or blood clots.

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 that involves cementing a part or all of the knee.

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I need a specific knee surgery due to arthritis, bone death, deformity, or certain fractures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 week, 6 month and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 week, 6 month and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 week, 6 month and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Post-operative leg alignment

Secondary outcome measures

2011 Knee Society Score (KSS) - TKA

2011 Knee Society Score (KSS) - UKA

Component Alignment - TKA

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CORI RoboticsExperimental Treatment1 Intervention

Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Smith & Nephew, Inc.Lead Sponsor

165 Previous Clinical Trials

22,341 Total Patients Enrolled

Kelli ArmstrongStudy ChairSmith & Nephew, Inc.

2 Previous Clinical Trials

234 Total Patients Enrolled

Julie LankiewiczStudy ChairSmith & Nephew, Inc.

3 Previous Clinical Trials

560 Total Patients Enrolled

Media Library

CORI Robotics (Robotic Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT04786119 — N/A

CORI Robotics (Robotic Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04786119 — N/A

Frequently Asked Questions

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

Are there any remaining vacancies in this experiment for individuals?

"According to the clinicaltrials.gov database, this investigation is currenlty recruiting individuals for participation. The details of the trial were originally submitted on February 17th 2021 and adjusted as recently as November 10th 2022."

Answered by AI

How many test subjects are engaged in the current research?

"In order to complete this trial, 140 patients that meet the pre-determined inclusion criteria must participate. Patients can partake in these experiments at Oregon Health & Science University (Portland) and OrthoNeuro (New Albany)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures

2021. "Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04786119.