Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems

NCT06284824 | Not Yet Recruiting FDA Device

• 1 other identifier: DPS-JMP-2022-040
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis; Knee Arthritis; Knee Disease

Keywords

robotic assistance; arthroplasty; TKA

Outcome Measures

Primary Outcomes (11)

• KSS

  Knee Society Score

  baseline

• KSS

  Knee Society Score

  6 week

• KSS

  Knee Society Score

  12 week

• KSS

  Knee Society Score

  1 year

• KOOS JR

  Knee injury and Osteoarthritis Outcome Score for Joint Replacement

  baseline

• KOOS JR

  Knee injury and Osteoarthritis Outcome Score for Joint Replacement

  6 week

• KOOS JR

  Knee injury and Osteoarthritis Outcome Score for Joint Replacement

  12 week

• KOOS JR

  Knee injury and Osteoarthritis Outcome Score for Joint Replacement

  1 year

• FJS-12 Knee

  Forgotten Joint Score

  6 week

• FJS-12 Knee

  Forgotten Joint Score

  12 week

• FJS-12 Knee

  Forgotten Joint Score

  1 year

Secondary Outcomes (1)

• Operative step time

  Intraoperative

Other Outcomes (2)

• Bone resected

  Intraoperative

• Costs for surgery

  Immediate post operative

Study Arms (2)

MAKO group

EXPERIMENTAL

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

Device: Stryker Triathlon with MAKO Robotic-Arm

VELYS group

EXPERIMENTAL

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

Device: DePuy Attune with VELYS Robotic-Assistance

Interventions

Stryker Triathlon with MAKO Robotic-Arm DEVICE

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

MAKO group

DePuy Attune with VELYS Robotic-Assistance DEVICE

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

VELYS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast Orthopedic Specialists: lead
• DePuy Orthopaedics: collaborator
• Stryker Orthopaedics: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• John Redmond, MD

  Southeast Orthopedic Specialists

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis Velez, BS

CONTACT

13214439922; alexisavelez@gmail.com

John Redmond, MD

CONTACT

9043286711; john.redmond@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share