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Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty | Clinical Trials | Clareo Health

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Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty

Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty: A Prospective, Non-Randomized Multi-Center Post-market Clinical Investigation

NCT04730271•DePuy Orthopaedics

View on ClinicalTrials.gov

Summary

The purpose of this post-market research study is to gather clinical and radiographic (X-ray) information about total knee replacement surgeries completed with the VELYS Robotic-Assisted Solution and with standard manual instrumentation. The VELYS Robotic-Assisted Solution helps the surgeon to plan bone cuts and then accurately achieve the planned cuts during the total knee replacement surgery. The study aims to compare how well the VELYS Robotic-Assisted system enables the surgeon to position the implants exactly as planned compared to manual instrumentation.

Eligibility

Age

22 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is male or female and between the ages of 22 and 85 years at the time of consent, inclusive.
•2. Subject has a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis or rheumatoid arthritis and in the opinion of the Investigator, is a suitable candidate for primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
•3. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor
•4. Subject is currently not permanently bedridden, as determined by the Investigator
•5. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
•6. Subject is able to read and comprehend the Informed Consent Document as well as complete the required PROs in English.
•7. Subject's pre-operative alignment is such that (in the opinion of the Investigator) it is appropriate for it to be adjusted to mechanical long leg alignment during surgery.

Exclusion Criteria

•1. The Subject is a woman who is pregnant or lactating.
•2. Contralateral knee has already been enrolled in this study.
•3. Subject had a contralateral amputation.
•4. Previous partial knee replacement (unicompartmental, bicompartamental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
•5. Subject has an active local or systemic infection
•6. Subject has loss of bone or musculature, osteoporosis, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to render the procedure unjustifiable in the opinion of the Investigator (e.g. absence of musculo-ligamentous supporting structures, joint neuropathy)
•7. Subject has severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity.
•8. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
•9. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.

Locations (5)

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Cuyuna Regional Medical Center

Crosby, Minnesota, United States

OrthoCarolina

Charlotte, North Carolina, United States

Campbell Clinic

Germantown, Tennessee, United States

Proliance Orthopedic Associates

Renton, Washington, United States

Key Dates

Start Date

February 23, 2021

Primary Completion Date

April 7, 2023

Completion Date

September 6, 2023

Last Updated

April 27, 2025

Enrollment

200

ACTUAL participants

Conditions

Osteo Arthritis KneeOsteoarthritis

Interventions

Total Knee Replacement

DEVICE

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

NCT07153471

Osteoarthritis

View study

RECRUITINGPHASE1

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

NCT07351968

Moderate Pain in Knee OsteoarthritisSevere Pain in Knee Osteoarthritis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

General vs Spinal in Total Joint Arthroplasty (TJA)

CBD for Pain Following Orthopedic Shoulder Surgery

PENG Block Variants With Dexamethasone and Dexmedetomidine in Older Adults

A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression