Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-09-27
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Total Knee Arthroplasty (TKA) performed using a medial congruent articular bearing surface design
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.
Total Knee Arthroplasty (TKA) performed using a posterior stabilized bearing design
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Vinay Aggarwal, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-00033
Identifier Type: -
Identifier Source: org_study_id
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