Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems

Launched by SOUTHEAST ORTHOPEDIC SPECIALISTS · Feb 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different robotic systems used for total knee replacement surgery, specifically looking at how well they work for patients with knee osteoarthritis or arthritis. Researchers want to find out if patients report different outcomes or experiences after surgery depending on which robotic system is used. Participants will have the surgery using one of the robots and will be asked to fill out surveys and have x-rays taken to help gather important data.

To be eligible for the study, participants should be between 18 and 80 years old and need to have a diagnosis of knee osteoarthritis. They must also be able to understand and sign the consent form, as well as attend follow-up appointments and complete questionnaires. However, some individuals may not qualify if they have certain health conditions or other specific factors. Overall, this trial aims to improve our understanding of how these robotic systems can enhance knee replacement surgery outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient must be a candidate for primary TKA (either Stryker Triathlon with MAKO Robotic-Arm or DePuy Attune with VELYS Robotic-Assistance).
• • Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of information to the Sponsor.
• • Individuals who are willing and able to complete follow up visits, questionnaires, and radiographic evaluations as specified by the study protocol.
• • Individuals who are male or non-pregnant female age 18-80 years at time of device implantation.
• • Patient has a diagnosis of primary osteoarthritis or degenerative joint disease of the knee.
• Exclusion Criteria:
• • Patient has a Body Mass Index (BMI) \> 40.
• • Patient has been diagnosed with osteoporosis or displays poor bone quality per the discretion of the investigator.
• • Patient has an active or suspected latent infection in affected knee joint. Patient has neuromuscular or neurosensory deficiency.
• • Patient is diagnosed with systemic disease or metabolic disorder (e.g., Lupus, Charcot's. Paget's).
• • Subject is a woman who is pregnant or lactating.
• • Patient has a contralateral amputation.
• • Patient's affected knee has a flexion contracture greater than 15 degrees.
• • Patient has history of post operative arthrofibrosis.
• • Patient's affected knee has a partial knee arthroplasty.
• • Patient has undergone contralateral TKA within the last three months.
• • Patient is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims.
• • Patient who is bedridden per the discretion of the investigator.
• • Patient has a medical condition with less than 2 years of life expectancy.