Persona MC vs PS RCT With ROSA

Not Applicable

Recruiting

• Conditions: Total Knee Arthroplasty
• Interventions: Device: Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design; Device: Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design

• Registration Number: NCT05391828
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-26
• Study Start: 2023-09-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-09
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total Knee Arthroplasty (TKA) performed using a medial congruent articular bearing surface design	Zimmer-Biomet Persona Medial Congruent (MC) Bearing Design	-
Total Knee Arthroplasty (TKA) performed using a posterior stabilized bearing design	Zimmer-Biomet Persona Posterior-Stabilized (PS) Bearing Design	-

Primary Outcome Measures

Name	Time	Method
European Quality of Life Five Dimension (EQ-5D) Score	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.
Forgotten Joint Score (FJS)	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.
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Average gait speed	Baseline, Year 2
Change in Average daily flight count	Baseline, Year 2
Change in Average daily step count	Baseline, Year 2

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States