Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSoutheast Orthopedic Specialists
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Stryker Triathlon with MAKO Robotic-Arm
- DePuy Attune with VELYS Robotic-Assistance
Treatment groups
120 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Southeast Orthopedic Specialists
Lead sponsor
DePuy Orthopaedics
Collaborator
Stryker Orthopaedics
Collaborator
Source ClinicalTrials.gov