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

NCT ID: NCT04730271

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2023-09-06

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Total Knee Replacement

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Total Knee Replacement

Intervention Type: DEVICE

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

Interventions

Total Knee Replacement

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian J Leslie, PhD

Role: STUDY_DIRECTOR

DePuy Synthes

Locations

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Cuyuna Regional Medical Center

Crosby, Minnesota, United States

OrthoCarolina

Charlotte, North Carolina, United States

Campbell Clinic

Germantown, Tennessee, United States

Proliance Orthopedic Associates

Renton, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DSJ_2019_08

Identifier Type: -

Identifier Source: org_study_id