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NCT Number: NCT05391828

Persona MC vs PS RCT With ROSA

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Location contact

Vinay Aggarwal

CONTACT

[email protected]

202-250-0679

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design

Device

TKA 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

Device

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.

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)

    Time frame: 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.

  2. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)

    Time frame: Week 6

    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.

  3. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)

    Time frame: Month 3

    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.

  4. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)

    Time frame: Year 1

    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.

  5. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)

    Time frame: Year 2

    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.

  6. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)

    Time frame: Year 5

    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.

  7. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)

    Time frame: Year 10

    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.

  8. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)

    Time frame: Year 20

    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.

  9. Forgotten Joint Score (FJS)

    Time frame: 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.

  10. Forgotten Joint Score (FJS)

    Time frame: Week 6

    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.

  11. Forgotten Joint Score (FJS)

    Time frame: Month 3

    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.

  12. Forgotten Joint Score (FJS)

    Time frame: Year 1

    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.

  13. Forgotten Joint Score (FJS)

    Time frame: Year 2

    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.

  14. Forgotten Joint Score (FJS)

    Time frame: Year 5

    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.

  15. Forgotten Joint Score (FJS)

    Time frame: Year 10

    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.

  16. Forgotten Joint Score (FJS)

    Time frame: Year 20

    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.

  17. European Quality of Life Five Dimension (EQ-5D) Score

    Time frame: 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.

  18. European Quality of Life Five Dimension (EQ-5D) Score

    Time frame: Week 6

    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.

  19. European Quality of Life Five Dimension (EQ-5D) Score

    Time frame: Month 3

    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.

  20. European Quality of Life Five Dimension (EQ-5D) Score

    Time frame: Year 1

    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.

  21. European Quality of Life Five Dimension (EQ-5D) Score

    Time frame: Year 2

    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.

  22. European Quality of Life Five Dimension (EQ-5D) Score

    Time frame: Year 5

    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.

  23. European Quality of Life Five Dimension (EQ-5D) Score

    Time frame: Year 10

    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.

  24. European Quality of Life Five Dimension (EQ-5D) Score

    Time frame: Year 20

    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 outcomes

  1. Change in Average gait speed

    Time frame: Baseline, Year 2

  2. Change in Average daily step count

    Time frame: Baseline, Year 2

  3. Change in Average daily flight count

    Time frame: Baseline, Year 2

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Waren

CONTACT

[email protected]

954 559 2251

Vinay Aggarwal, MD

CONTACT

[email protected]

202 250 0679

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
May 26, 2022
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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