Total Knee Arthroplasty
Conditions
Brief summary
A randomized, controlled study comparing two total knee implant devices, Persona medial congruent (MC) vs posterior stabilized (PS). These surgeries will be performed using the ROSA robotic system. Patients will be followed up to 5 years.
Interventions
DEVICEZimmer-Biomet Persona Medial Congruent (MC) Bearing Design
TKA will be performed using the MC Bearing Design. The MC bearing provides medial stability and lateral mobility to facilitate more natural motion.
DEVICEZimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design
TKA will be performed using the PS Bearing Design. The PS bearings are designed to provide ±1.5 degrees varus/valgus constraint and ± 5.5 degrees internal/external rotation constraint.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥18 years of age 2. Patients scheduled an elective primary TKA for a diagnosis of osteoarthritis or inflammatory arthritis using the ROSA Knee System. 3. Patient is willing to cooperate and follow study protocol and visit schedule 4. Subject has access to a device is capable of pairing to the Apple Watch, supporting application updates and is compatible with the mymobility App.
Exclusion criteria
1. Patient is pregnant 2. Patient is unable to provide written consent 3. Revision TKA 4. History of prior infection in the affected knee 5. History of prior open surgery with significant hardware in place on the affected knee (i.e. prior distal femur or proximal tibia fracture or osteotomy) 6. Preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) | Baseline | KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health. |
| Forgotten Joint Score (FJS) | Baseline | FJS is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. FJS consists of 12 questions - the total score range is 0-100. The higher the score, the less the patient is aware of their affected joint when performing daily activities. |
| European Quality of Life Five Dimension (EQ-5D) Score | Baseline | The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem. A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status (0-100) with 100 indicating the best health status. |
Secondary
| Measure | Time frame |
|---|---|
| Change in Average gait speed | Baseline, Year 2 |
| Change in Average daily step count | Baseline, Year 2 |
| Change in Average daily flight count | Baseline, Year 2 |
Countries
United States
Contacts
CONTACTVinay Aggarwal, MD
CONTACTDaniel Waren
PRINCIPAL_INVESTIGATORVinay Aggarwal, MD
NYU Langone Health
Outcome results
None listed