Persona MC vs PS RCT With ROSA

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Device: Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design
* Device: Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patient is pregnant Patient is unable to provide written consent Revision TKA History of prior infection in the affected knee 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) Preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total Knee Arthroplasty (TKA) performed using a medial congruent articular bearing surface design<br> | Device: Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design<br>* TKA will be performed using the MC Bearing Design. The MC bearing provides medial stability and lateral mobility to facilitate more natural motion.<br>|
| Active Comparator: Total Knee Arthroplasty (TKA) performed using a posterior stabilized bearing design<br> | Device: Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Year 20 | 
| Forgotten Joint Score (FJS) | 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. | Baseline | 
| Forgotten Joint Score (FJS) | 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. | Week 6 | 
| Forgotten Joint Score (FJS) | 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. | Month 3 | 
| Forgotten Joint Score (FJS) | 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. | Year 1 | 
| Forgotten Joint Score (FJS) | 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. | Year 2 | 
| Forgotten Joint Score (FJS) | 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. | Year 5 | 
| Forgotten Joint Score (FJS) | 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. | Year 10 | 
| Forgotten Joint Score (FJS) | 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. | Year 20 | 
| European Quality of Life Five Dimension (EQ-5D) Score | 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. | Year 1 | 
| European Quality of Life Five Dimension (EQ-5D) Score | 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. | Year 2 | 
| European Quality of Life Five Dimension (EQ-5D) Score | 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. | Year 5 | 
| European Quality of Life Five Dimension (EQ-5D) Score | 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. | Year 10 | 
| European Quality of Life Five Dimension (EQ-5D) Score | 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. | Year 20 | 
| European Quality of Life Five Dimension (EQ-5D) Score | 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. | Baseline | 
| European Quality of Life Five Dimension (EQ-5D) Score | 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. | Week 6 | 
| European Quality of Life Five Dimension (EQ-5D) Score | 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. | Month 3 | 
| 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. | Baseline | 
| 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. | Week 6 | 
| 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. | Month 3 | 
| 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. | Year 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. | Year 2 | 
| 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. | Year 5 | 
| 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. | Year 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |