CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 181 enrolled
Drug / intervention
PERSONA Total Knee +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03969654
NCT03969654N/ACompleted
CompareCT.gov

ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System

Zimmer Biomet·interventional·Posted May 31, 2019·Updated May 3, 2024

In Brief

A clinical study evaluating PERSONA Total Knee, Vanguard Total Knee, and 1 other intervention for Knee Pain and 4 related conditions. Completed, enrolled 181 participants across 5 sites.

Detailed Summary

This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 31, 2019
Enrollment StartMay 1, 2020
Primary CompletionSep 22, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 7.1 years ago

Interventions

PERSONA Total Kneedevice

Primary Total Knee Arthroplasty

Vanguard Total Kneedevice

Primary Total Knee Arthroplasty

NexGen Total Kneedevice

Primary Total Knee Arthroplasty