Knee Arthritis, Knee Disease, Knee Osteoarthritis
Conditions
Keywords
robotic assistance, arthroplasty, TKA
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.
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
DEVICEStryker Triathlon with MAKO Robotic-Arm
Implant is the Stryker Triathlon total knee arthroplasty and the robotic device is the MAKO robotic-arm
DEVICEDePuy Attune with VELYS Robotic-Assistance
Implant is the DePuy Attune total knee arthroplasty and the robotic device is the VELYS robotic-assistance
Sponsors
DePuy Orthopaedics
Stryker Orthopaedics
Southeast Orthopedic Specialists
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KSS | baseline | Knee Society Score |
| KOOS JR | baseline | Knee injury and Osteoarthritis Outcome Score for Joint Replacement |
| FJS-12 Knee | 6 week | Forgotten Joint Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative step time | Intraoperative | Timing for use of robot during surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bone resected | Intraoperative | Amount of bone resected |
| Costs for surgery | Immediate post operative | Factors associated with insurance costs for surgery |
Contacts
Primary ContactAlexis Velez, BS
Backup ContactJohn Redmond, MD
Outcome results
None listed