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

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: Active, not recruiting
• Conditions: Osteoarthritis; Osteo Arthritis Knee
• Intervention / Treatment: Device: Total Knee Replacement

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Accuracy of Long leg Alignment	To determine whether the accuracy to plan of the long leg alignment achieved with the 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 on long-leg X-rays taken at 12 weeks. If non-inferiority is successfully demonstrated, then the study will be deemed to be successful, and a test for superiority of mechanical axis alignment achieved with VELYS Robotic-Assisted Solution will be conducted.	12 weeks post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type and frequency of adverse events	Evaluate the nature, severity, and frequency of local adverse events associated with the use of the VELYS Robotic-Assisted Solution in total knee arthroplasty during the procedure and within the subsequent 12 weeks, 90 days and 1 year.	Day of operation (intraoperative), 12 weeks, 1 year
Soft tissue damage	Investigators will conduct 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)
Alignment Outliers	The alignment outliers (>3 degrees outside of plan) in both Manual and Robotics cohorts will be summarized	12 weeks
Surgical time	The surgical time (skin to skin), Operative time (wheels in wheels out) and total operative room utilization time will be summarized for both manual and robotic-assisted cohorts.	Day of operation (intraoperative)
Accuracy of position of components	Individual component alignment achieved with manual instruments and Robotic-assisted in the frontal and sagittal planes will be summarized, specifically: distal femoral varus-valgus (FM), proximal tibial varus-valgus (TM), femoral component flexion and tibial slope.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Learning curve	To evaluate impact of surgeon learning curve on the VELYS Robotic-Assisted system on accuracy of surgical procedure (assessed via accuracy of long leg alignment to plan), patient reported outcomes, safety, and surgical time.	Day of operation (intraoperative), 12 weeks, 1 year
EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change from baseline	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.	12 weeks, 1 year
Forgotten Joint Score (FJS-12)	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, 1 year
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Change from baseline	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	A single patient reported question that asks the patient to score their level of satisfaction with their knee from 0-10.	12 weeks, 1 year
Pain - Change from baseline	Subjects are asked how much knee pain they have had in the last week while resting (0-10) and during activity (0-10)	12 weeks, 1 year

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics
• Investigators: Study Director: Ian J Leslie, PhD, DePuy Synthes

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2021
• Primary Completion (Actual): April 7, 2023
• Study Completion (Estimated): February 15, 2024

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 1, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Arthroplasty; Knee; Robotic-Assisted; VELYS; Accuracy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID 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