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

Not Applicable

Completed

• Conditions: Osteo Arthritis Knee; Osteoarthritis
• Interventions: Device: Total Knee Replacement

• Registration Number: NCT04730271
• Lead Sponsor: DePuy Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-01-29
• Study Start: 2021-02-23
• Primary Completion: 2023-04-07
• Study Completion: 2023-09-06
• Results First Submitted: 2024-04-04
• Results First Submitted QC: 2024-07-10
• Results First Posted: 2024-07-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Robotic-Assisted Arm	Total Knee Replacement	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.
Manual Arm	Total Knee Replacement	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.

Primary Outcome Measures

Name	Time	Method
Accuracy of the Hip-Knee-Ankle Angle (HKA) Measured on Long-leg X-rays at 12 Weeks.	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.

Secondary Outcome Measures

Name	Time	Method
Accuracy of the Distal Femoral Varus-valgus Angle Measured on Long Leg X-rays at 12 Weeks.	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.
Accuracy of the Proximal Tibial Varus-valgus Angle Measured on Long-leg X-rays at 12 Weeks	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.
Accuracy of Femoral Component Flexion Angle Measured on Lateral X-rays at 12 Weeks	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.
Accuracy of the Tibial Slope Angle Measured on Lateral X-rays at 12 Weeks	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.
Type and Frequency of Adverse Events	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.
Soft Tissue Damage	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.

Trial Locations

Locations (5)

Cuyuna Regional Medical Center; 🇺🇸 Crosby, Minnesota, United States

Proliance Orthopedic Associates; 🇺🇸 Renton, Washington, United States

Campbell Clinic; 🇺🇸 Germantown, Tennessee, United States

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

OrthoCarolina; 🇺🇸 Charlotte, North Carolina, United States