Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems

Southeast Orthopedic Specialists

Status: Not yet enrolling

Conditions: Knee Arthritis; Knee Disease; Knee Osteoarthritis

Treatments: Device: Stryker Triathlon with MAKO Robotic-Arm; Device: DePuy Attune with VELYS Robotic-Assistance

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT06284824

DPS-JMP-2022-040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

MAKO group

Experimental group

Description:

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

Treatment:

Device: Stryker Triathlon with MAKO Robotic-Arm

VELYS group

Experimental group

Description:

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

Treatment:

Device: DePuy Attune with VELYS Robotic-Assistance