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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05391828
Other study ID # 22-00033
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 27, 2023
Est. completion date December 2026

Study information

Verified date November 2023
Source NYU Langone Health
Contact Vinay Aggarwal, MD
Phone 202 250 0679
Email Vinay.Aggarwal@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Zimmer-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.
Zimmer-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.

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Secondary Change in Average gait speed Baseline, Year 2
Secondary Change in Average daily step count Baseline, Year 2
Secondary Change in Average daily flight count Baseline, Year 2
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