Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems

NCT ID: NCT06284824

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2027-05-31

Brief Summary

The goal of this prospective study is to compare two different knee replacement robots. This study will look at patient reported outcome measures and data collected during the operation. The main questions this study aims to answer include:

• Will the patient reported outcomes differ between the two groups?
• Will the intraoperative data differ between the two groups? Participants will undergo total knee replacement with one of the two robots, complete standardized surveys, and have x-rays taken.

Detailed Description

The purpose of this study is to compare two different total knee arthroplasty (TKA) robotic assisted (RA) devices. This study will compare patient reported outcome measures prior to and after surgery. These surveys will be used determine if there are differences in patient recovery after TKA depending on the robot used. Radiographs will also be taken and used to compare component positioning. Intraoperative data will be collected to compare OR efficiency of the two systems.

Conditions

Knee Osteoarthritis; Knee Arthritis; Knee Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MAKO group

Patients in this arm will receive the Stryker Triathlon implant and the MAKO robotic arm will be used during surgery.

Group Type: EXPERIMENTAL

Stryker Triathlon with MAKO Robotic-Arm

Intervention Type: DEVICE

Implant is the Stryker Triathlon total knee arthroplasty and the robotic device is the MAKO robotic-arm

VELYS group

Patients in this arm will receive the DePuy Attune implant and the VELYS robotic arm will be used during surgery.

Group Type: EXPERIMENTAL

DePuy Attune with VELYS Robotic-Assistance

Intervention Type: DEVICE

Implant is the DePuy Attune total knee arthroplasty and the robotic device is the VELYS robotic-assistance

Interventions

Stryker Triathlon with MAKO Robotic-Arm

Implant is the Stryker Triathlon total knee arthroplasty and the robotic device is the MAKO robotic-arm

Intervention Type: DEVICE

DePuy Attune with VELYS Robotic-Assistance

Implant is the DePuy Attune total knee arthroplasty and the robotic device is the VELYS robotic-assistance

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: collaborator

Stryker Orthopaedics

INDUSTRY

Sponsor Role: collaborator

Southeast Orthopedic Specialists

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Redmond, MD

Role: PRINCIPAL_INVESTIGATOR

Southeast Orthopedic Specialists

Central Contacts

Alexis Velez, BS

Role: CONTACT

alexisavelez@gmail.com

13214439922

John Redmond, MD

Role: CONTACT

john.redmond@live.com

9043286711

Other Identifiers

DPS-JMP-2022-040

Identifier Type: -

Identifier Source: org_study_id