Persona MC vs PS RCT With ROSA
ConditionTotal Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients ≥18 years of age
Patients scheduled an elective primary TKA for a diagnosis of osteoarthritis or inflammatory arthritis using the ROSA Knee System.
Patient is willing to cooperate and follow study protocol and visit schedule
Subject has access to a device is capable of pairing to the Apple Watch, supporting application updates and is compatible with the mymobility App.
Disqualifiers
Patient is pregnant
Patient is unable to provide written consent
Revision TKA
History of prior infection in the affected knee
Trial design
Design model
Parallel
Treatments tested in this trial
Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design
DeviceTKA will be performed using the MC Bearing Design. The MC bearing provides medial stability and lateral mobility to facilitate more natural motion.
Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design
DeviceTKA 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Total Knee Arthroplasty (TKA) performed using a medial congruent articular bearing surface designExperimental treatment 1 intervention
Group B: Total Knee Arthroplasty (TKA) performed using a posterior stabilized bearing designActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
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.
Time frame
Baseline2
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
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.
Time frame
Week 63
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
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.
Time frame
Month 34
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
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.
Time frame
Year 1Secondary outcomes
1
Change in Average gait speed
Time frame
Baseline, Year 22
Change in Average daily step count
Time frame
Baseline, Year 23
Change in Average daily flight count
Time frame
Baseline, Year 2Sponsors and contacts
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Source ClinicalTrials.gov