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

NCT04730271 | Completed Results FDA Device

• 1 other identifier: DSJ_2019_08
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Osteo Arthritis Knee; Osteoarthritis

Keywords

Arthroplasty; Knee; Robotic-Assisted; VELYS; Accuracy

Outcome Measures

Primary Outcomes (1)

• Accuracy of the Hip-Knee-Ankle Angle (HKA) Measured on Long-leg X-rays at 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 Outcomes (6)

• Accuracy of the Distal Femoral Varus-valgus Angle Measured on Long Leg X-rays at 12 Weeks.

  12 weeks

• Accuracy of the Proximal Tibial Varus-valgus Angle Measured on Long-leg X-rays at 12 Weeks

  12 weeks

• Accuracy of Femoral Component Flexion Angle Measured on Lateral X-rays at 12 Weeks

  12 weeks

• Accuracy of the Tibial Slope Angle Measured on Lateral X-rays at 12 Weeks

  12 weeks

• Type and Frequency of Adverse Events

  12 weeks, 1 year

Other Outcomes (10)

• EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change From Baseline

  1 year

• Forgotten Joint Score (FJS-12)

  12 weeks and 1 year

• Knee Injury and Osteoarthritis Outcome Score (KOOS) ADL - Change From Baseline

  12 weeks, 1 year

Study Arms (2)

Manual Arm

ACTIVE COMPARATOR

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

Robotic-Assisted Arm

EXPERIMENTAL

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

Interventions

Total Knee Replacement DEVICE

Subjects will be implanted with an ATTUNE Primary total knee replacement.

Manual Arm; Robotic-Assisted Arm

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (5)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Cuyuna Regional Medical Center

Crosby, Minnesota, 56441, United States

Location

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

Proliance Orthopedic Associates

Renton, Washington, 98055, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Limitations and Caveats

Adverse events were coded as reported by sites per MeDRA. This resulted in some spreading of AEs. For example, "swelling" and "knee swelling" were coded differently according to best practice. Future publications will consolidate similar coded events and clarify which were combined.

Results Point of Contact

• Title: Ian Leslie
• Organization: DePuy Synthes

ileslie1@its.jnj.com

N/A

Study Officials

• Ian J Leslie, PhD

  DePuy Synthes

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Quantitative analysis of the X-rays will be conducted by a third party who will be blinded to the treatment group.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: February 23, 2021
• Primary Completion: April 7, 2023
• Study Completion: September 6, 2023
• Last Updated: April 27, 2025
• Results First Posted: July 11, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (5)