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Robotic-Assisted Surgery

Robotic-Assisted vs Manual Knee Replacement for Osteoarthritis

N/A
Waitlist Available
Research Sponsored by DePuy Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is male or female and between the ages of 22 and 85 years at the time of consent, inclusive
Subject is currently not permanently bedridden, as determined by the Investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks, 1 year
Awards & highlights

Study Summary

This trial will compare X-rays of patients who had surgery with the VELYS system to those who had surgery with manual instrumentation, in order to see how accurate the VELYS system is in placement of implants.

Who is the study for?
This trial is for adults aged 22-85 with severe joint pain or disability from osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis suitable for total knee replacement. Candidates must understand and consent to the study in English and be able to attend all visits. Pregnant women, those with prior knee surgeries on the same leg, recent participation in other trials, or ongoing legal claims are excluded.Check my eligibility
What is being tested?
The study compares traditional manual total knee replacement surgery with a procedure using the VELYS Robotic-Assisted Solution. It aims to determine if this robotic system improves implant positioning accuracy compared to standard methods.See study design
What are the potential side effects?
While specific side effects of using VELYS Robotic-Assisted Solution aren't detailed here, typical risks of knee replacement include infection, blood clots, implant issues like loosening or wear, nerve damage and persistent pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 22 and 85 years old.
Select...
I am not permanently bedridden.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks, 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks, 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy of Long leg Alignment
Secondary outcome measures
Accuracy of position of components
Alignment Outliers
Soft tissue damage
+2 more
Other outcome measures
EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change from baseline
Forgotten Joint Score (FJS-12)
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Change from baseline
+3 more

Side effects data

From 2013 Phase 4 trial • 50 Patients • NCT01140815
12%
Revision knee arthroplasty
4%
Knee stiff
100%
80%
60%
40%
20%
0%
Study treatment Arm
Deuce (Study)
Total (Control)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Robotic-Assisted ArmExperimental Treatment1 Intervention
Subjects enrolled into this arm will receive an ATTUNE primary total knee replacement that has been implanted with the use of the VELYS Robotic-Assisted Solution device.
Group II: Manual ArmActive Control1 Intervention
Subjects enrolled into this arm of the study will receive an ATTUNE primary total knee replacement that has been implanted using manual instrumentation which is the current standard of care at the participating sites.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total Knee Replacement
2018
Completed Phase 4
~1490

Find a Location

Who is running the clinical trial?

DePuy OrthopaedicsLead Sponsor
79 Previous Clinical Trials
25,639 Total Patients Enrolled
44 Trials studying Osteoarthritis
10,713 Patients Enrolled for Osteoarthritis
Ian J Leslie, PhDStudy DirectorDePuy Synthes

Media Library

Osteoarthritis Research Study Groups: Manual Arm, Robotic-Assisted Arm

Frequently Asked Questions

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

Are there multiple sites in the United States conducting this experiment?

"This trial is hosted in 5 centres, which are situated in Renton, Crosby and Germantown as well as other localities. To reduce the travel burden of patients who enroll, it is advisable to choose a clinic that is close by."

Answered by AI

Who is eligible to take part in this medical research experiment?

"This clinical trial seeks 200 volunteers aged 22 to 85 with advanced arthrosis. Eligible candidates must meet the criteria below: being of either sex, having a severely painful or disabled joint due to any form of arthritis that is suitable for primary total knee replacement surgery using specific devices and pre-operative alignment appropriate for mechanical long leg adjustment during treatment."

Answered by AI

Is recruitment for this research ongoing?

"Indeed, clinicaltrials.gov indicates that this experiment is not currently accepting patients into the study; it was first posted on February 9th 2021 and last amended on November 28 2022. Currently there are 693 other trials looking for participants."

Answered by AI

Is there an upper age limit to be considered for this research?

"The required age range for this trial is between 22 and 85 years old, which are the conditions imposed by its inclusion criteria."

Answered by AI

Who else is applying?

What state do they live in?
Vermont
Washington
North Carolina
What site did they apply to?
OrthoCarolina
Proliance Orthopedic Associates
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
2
3+

Why did patients apply to this trial?

I’ve had both knees replaced.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty
2021. "Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04730271.
~48 spots leftby Apr 2025
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