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Not yet recruiting NCT06284824

Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems

No phase Interventional Knee Osteoarthritis Knee Arthritis Knee Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stryker Triathlon with MAKO Robotic-Arm, DePuy Attune with VELYS Robotic-Assistance.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis, Knee Arthritis, Knee Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

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

Primary outcome measures

  • KSS [Time frame: baseline]
  • KSS [Time frame: 6 week]
  • KSS [Time frame: 12 week]
  • KSS [Time frame: 1 year]
  • KOOS JR [Time frame: baseline]
  • KOOS JR [Time frame: 6 week]
  • KOOS JR [Time frame: 12 week]
  • KOOS JR [Time frame: 1 year]
  • FJS-12 Knee [Time frame: 6 week]
  • FJS-12 Knee [Time frame: 12 week]
Secondary outcome measures (1)
  • Operative step time [Time frame: Intraoperative]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06284824 · DPS-JMP-2022-040

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗