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

DePuy Synthes

Status: Completed

Conditions: Osteoarthritis; Osteo Arthritis Knee

Treatments: Device: Total Knee Replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT04730271

DSJ_2019_08

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 22 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Manual Arm

Active Comparator group

Description:

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.

Treatment:

Device: Total Knee Replacement

Robotic-Assisted Arm

Experimental group

Description:

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.

Treatment:

Device: Total Knee Replacement