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

  • STATUS
    Recruiting
  • End date
    Dec 15, 2023
  • participants needed
    200
  • sponsor
    DePuy Orthopaedics
Updated on 22 September 2022
x-rays
total knee replacement
rheumatoid arthritis
traumatic arthritis
joint reconstruction

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.

Details
Condition Osteo Arthritis Knee, Osteoarthritis
Treatment total knee replacement
Clinical Study IdentifierNCT04730271
SponsorDePuy Orthopaedics
Last Modified on22 September 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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