Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems

Knee Osteoarthritis Clinical Trial

Official title:

Prospective, Randomized, Single-center Study Comparing the Stryker MAKO™ Robotic-Arm Assisted Total Knee Arthroplasty and the DePuy VELYS™ Robotic-Assisted Solution for Total Knee Arthroplasty.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06284824
• Other study ID #: DPS-JMP-2022-040
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: Southeast Orthopedic Specialists
• Contact: Alexis Velez, BS
• Phone: 13214439922
• Email: alexisavelez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 2027
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Arthritis
• Knee Disease
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Stryker Triathlon with MAKO Robotic-Arm
Implant is the Stryker Triathlon total knee arthroplasty and the robotic device is the MAKO robotic-arm
• DePuy Attune with VELYS Robotic-Assistance
Implant is the DePuy Attune total knee arthroplasty and the robotic device is the VELYS robotic-assistance

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Southeast Orthopedic Specialists	DePuy Orthopaedics, Stryker Orthopaedics

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bone resected	Amount of bone resected	Intraoperative
Other	Costs for surgery	Factors associated with insurance costs for surgery	Immediate post operative
Primary	KSS	Knee Society Score	baseline
Primary	KSS	Knee Society Score	6 week
Primary	KSS	Knee Society Score	12 week
Primary	KSS	Knee Society Score	1 year
Primary	KOOS JR	Knee injury and Osteoarthritis Outcome Score for Joint Replacement	baseline
Primary	KOOS JR	Knee injury and Osteoarthritis Outcome Score for Joint Replacement	6 week
Primary	KOOS JR	Knee injury and Osteoarthritis Outcome Score for Joint Replacement	12 week
Primary	KOOS JR	Knee injury and Osteoarthritis Outcome Score for Joint Replacement	1 year
Primary	FJS-12 Knee	Forgotten Joint Score	6 week
Primary	FJS-12 Knee	Forgotten Joint Score	12 week
Primary	FJS-12 Knee	Forgotten Joint Score	1 year
Secondary	Operative step time	Timing for use of robot during surgery	Intraoperative