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

April 25, 2025 updated by: DePuy Orthopaedics

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
    • Minnesota
      • Crosby, Minnesota, United States, 56441
        • Cuyuna Regional Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Campbell Clinic
    • Washington
      • Renton, Washington, United States, 98055
        • Proliance Orthopedic Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Manual Arm
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.
Device: Total Knee Replacement
Subjects will be implanted with an ATTUNE Primary total knee replacement.
Experimental: Robotic-Assisted Arm
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.
Device: Total Knee Replacement
Subjects will be implanted with an ATTUNE Primary total knee replacement.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accuracy of the Hip-Knee-Ankle Angle (HKA) Measured on Long-leg X-rays at 12 Weeks.
Time Frame: 12 weeks
The primary objective of this clinical investigation is to evaluate whether the accuracy to plan of the long leg alignment achieved with VELYS Robotic-Assisted Solution is non-inferior to the accuracy to plan of the long leg alignment achieved with the manual ATTUNE Intuition instrumentation. This will be assessed by measuring the Hip-Knee-Ankle angle (HKA) on long-leg X-rays taken at 12 weeks and comparing to the planned HKA. A smaller number represents improved accuracy and a better outcome.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accuracy of the Distal Femoral Varus-valgus Angle Measured on Long Leg X-rays at 12 Weeks.
Time Frame: 12 weeks
The accuracy of the distal femoral varus-valgus angle was assessed by comparing the angle measured on an X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome.
12 weeks
Accuracy of the Proximal Tibial Varus-valgus Angle Measured on Long-leg X-rays at 12 Weeks
Time Frame: 12 weeks
The accuracy of the proximal tibial varus-valgus angle was assessed by comparing the angle measured on an X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome.
12 weeks
Accuracy of Femoral Component Flexion Angle Measured on Lateral X-rays at 12 Weeks
Time Frame: 12 weeks
The accuracy of the femoral component flexion angle was assessed by comparing the angle measured on a lateral X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome.
12 weeks
Accuracy of the Tibial Slope Angle Measured on Lateral X-rays at 12 Weeks
Time Frame: 12 weeks
The accuracy of the Tibial slope angle was assessed by comparing the angle measured on a lateral X-ray 12 weeks post operatively to the angle that the surgeon was targeting or planning intra operatively. A smaller number represents improved accuracy and a better outcome.
12 weeks
Soft Tissue Damage
Time Frame: Day of operation (intraoperative)
Investigators conducted an intra-operative assessment of the condition and function of key soft tissue structures in both Manual and Robotic-assisted cohorts.
Day of operation (intraoperative)
Type and Frequency of Adverse Events
Time Frame: 12 weeks, 1 year
Rate of local Adverse events and local serious adverse events reported within the first 90 days and the first year post surgery. Local means at the site of the procedure (i.e. the operated Knee). Serious adverse events are events that required medical or surgical intervention to prevent a serious impairment to health.
12 weeks, 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change From Baseline
Time Frame: 1 year
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient with 1 (meaning full health) and 0 (meaning a state as bad as being dead).
1 year
Forgotten Joint Score (FJS-12)
Time Frame: 12 weeks and 1 year
The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is.
12 weeks and 1 year
Knee Injury and Osteoarthritis Outcome Score (KOOS) ADL - Change From Baseline
Time Frame: 12 weeks, 1 year
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms.
12 weeks, 1 year
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain - Change From Baseline
Time Frame: 12 weeks, 1 year
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms.
12 weeks, 1 year
Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms - Change From Baseline
Time Frame: 12 weeks, 1 year
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms.
12 weeks, 1 year
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports and Recreation - Change From Baseline
Time Frame: 12 weeks, 1 year
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms.
12 weeks, 1 year
Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life - Change From Baseline
Time Frame: 12 weeks, 1 year
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms.
12 weeks, 1 year
Subject Satisfaction With Knee Replacement
Time Frame: 12 weeks, 1 year
A single patient reported question that asks the patient to score their level of satisfaction with their knee from 0-10, with 0 being fully satisfied and 10 being fully unsatisfied
12 weeks, 1 year
Pain - Change From Baseline
Time Frame: 12 weeks, 1 year
Subjects are asked how much knee pain they have had in the last week while resting (0-10) and during activity (0-10) with 0 being no pain and 10 being worst pain, therefore lower score is a better outcome.
12 weeks, 1 year
Learning Curve
Time Frame: 12 Weeks
The effect of learning curve on the accuracy was assessed by comparing the accuracy between the first 10 cases each surgeon completed and the subsequent cases. The accuracy was assessed by measuring the Hip-Knee-Ankle angle (HKA) on long-leg X-rays taken at 12 weeks and comparing to the planned HKA. A smaller number represents improved accuracy and a better outcome.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DePuy Orthopaedics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ian J Leslie, PhD, DePuy Synthes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 7, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DSJ_2019_08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis

Clinical Trials on Total Knee Replacement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings