Clinical trial NCT05391828: Persona MC vs PS RCT With ROSA
Official title: Randomized Control Trial Comparing Zimmer Biomet Persona Medial Congruent Versus Posterior Stabilized Total Knee Arthroplasty for Treatment of Knee Arthritis Using the ROSA Knee System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
timeFrame: Baseline
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
timeFrame: Week 6
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
timeFrame: Month 3
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
timeFrame: Year 1
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
timeFrame: Year 2
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
timeFrame: Year 5
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
timeFrame: Year 10
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
timeFrame: Year 20
measure: Forgotten Joint Score (FJS)
timeFrame: Baseline
measure: Forgotten Joint Score (FJS)
timeFrame: Week 6
measure: Forgotten Joint Score (FJS)
timeFrame: Month 3
measure: Forgotten Joint Score (FJS)
timeFrame: Year 1
measure: Forgotten Joint Score (FJS)
timeFrame: Year 2
measure: Forgotten Joint Score (FJS)
timeFrame: Year 5
measure: Forgotten Joint Score (FJS)
timeFrame: Year 10
measure: Forgotten Joint Score (FJS)
timeFrame: Year 20
measure: European Quality of Life Five Dimension (EQ-5D) Score
timeFrame: Baseline
measure: European Quality of Life Five Dimension (EQ-5D) Score
timeFrame: Week 6
measure: European Quality of Life Five Dimension (EQ-5D) Score
timeFrame: Month 3
measure: European Quality of Life Five Dimension (EQ-5D) Score
timeFrame: Year 1
measure: European Quality of Life Five Dimension (EQ-5D) Score
timeFrame: Year 2
measure: European Quality of Life Five Dimension (EQ-5D) Score
timeFrame: Year 5
measure: European Quality of Life Five Dimension (EQ-5D) Score
timeFrame: Year 10
measure: European Quality of Life Five Dimension (EQ-5D) Score
timeFrame: Year 20
Secondary outcomes:
measure: Change in Average gait speed
timeFrame: Baseline, Year 2
measure: Change in Average daily step count
timeFrame: Baseline, Year 2
measure: Change in Average daily flight count
timeFrame: Baseline, Year 2
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Vinay Aggarwal, MD
role: PRINCIPAL_INVESTIGATOR
References: