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

Sponsor

DePuy Orthopaedics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04730271

Collaborator

(none)

200

Enrollment

Locations

Arms

34.1

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteo Arthritis Knee Osteoarthritis	Device: Total Knee Replacement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Quantitative analysis of the X-rays will be conducted by a third party who will be blinded to the treatment group.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 9, 2021

Anticipated Primary Completion Date :

Feb 15, 2023

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Accuracy of Long leg Alignment [12 weeks post operative]
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.

Secondary Outcome Measures

Type and frequency of adverse events [Day of operation (intraoperative), 12 weeks, 1 year]
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.
Soft tissue damage [Day of operation (intraoperative)]
Investigators will conduct an intra-operative assessment of the condition and function of key soft tissue structures in both Manual and Robotic-assisted cohorts.
Alignment Outliers [12 weeks]
The alignment outliers (>3 degrees outside of plan) in both Manual and Robotics cohorts will be summarized
Surgical time [Day of operation (intraoperative)]
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.
Accuracy of position of components [12 weeks]
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.

Other Outcome Measures

Learning curve [Day of operation (intraoperative), 12 weeks, 1 year]
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.
EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change from baseline [12 weeks, 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.
Forgotten Joint Score (FJS-12) [12 weeks, 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.
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Change from baseline [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.
Subject Satisfaction with Knee Replacement [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.
Pain - Change from baseline [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject is male or female and between the ages of 22 and 85 years at the time of consent, inclusive.
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.
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
Subject is currently not permanently bedridden, as determined by the Investigator
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.
Subject is able to read and comprehend the Informed Consent Document as well as complete the required PROs in English.
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:

The Subject is a woman who is pregnant or lactating.
Contralateral knee has already been enrolled in this study.
Subject had a contralateral amputation.
Previous partial knee replacement (unicompartmental, bicompartamental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
Subject has an active local or systemic infection
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)
Subject has severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity.
Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sinai Hospital of Baltimore	Baltimore	Maryland	United States	21215
2	Cuyuna Regional Medical Center	Crosby	Minnesota	United States	56441
3	OrthoCarolina	Charlotte	North Carolina	United States	28207
4	Campbell Clinic	Germantown	Tennessee	United States	38138
5	Proliance Orthopedic Associates	Renton	Washington	United States	98055