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NCT03969654 · ClinicalTrials.gov registry record · NA
ROSA Robot Used in Total Knee Replacement Post Market Study
A NA study of Rheumatoid Arthritis and Knee Pain, sponsored by Zimmer Biomet.
- Completed
- Registry status
- NA
- Development phase
- 181
- Enrollment target
- 5
- Study locations
NCT03969654: Completed NA study of Rheumatoid Arthritis and Knee Pain, sponsored by Zimmer Biomet.
NCT03969654 is a NA study of Rheumatoid Arthritis and Knee Pain that has completed, run by Zimmer Biomet. The registered enrollment target is 181 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03969654, a NA study of Rheumatoid Arthritis and Knee Pain, has completed, sponsored by Zimmer Biomet.
- COMPLETED
- Registry status
- NA
- Development phase
- 181 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General Health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. The scale is from 0-1, 0 being dead and 1 being the best possible score.
Conditions Studied
Interventions
- DEVICE PERSONA Total Knee
- DEVICE Vanguard Total Knee
- DEVICE NexGen Total Knee
Study Locations (5)
Colorado
- Vail-Summit Orthopaedics - Vail
- Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC - Westminster
Illinois
- SIU School of Medicine - Springfield
Michigan
- Henry Ford Health System - Detroit
Virginia
- OrthoVirginia Chippenham - North Chesterfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2020-05-01 |
| Est. Completion | 2023-09-22 |
| Phase | NA |
What the finished NCT03969654 record still lists
NCT03969654 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (96% lower).
The record links to 5 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 3 interventions - of which PERSONA Total Knee is the first listed.
NCT03969654 lists 5 locations in 4 states (Colorado, Illinois, Michigan).
Frequently Asked Questions
What is clinical trial NCT03969654 about?
NCT03969654 is a clinical study titled "ROSA Robot Used in Total Knee Replacement Post Market Study". 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 o...
What is the current status of trial NCT03969654?
This trial is currently completed. It is a NA study. The enrollment target is 181 participants. The study started on 2020-05-01. Estimated completion is 2023-09-22.
What conditions does trial NCT03969654 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Knee Pain, Moderate Varus, Valgus or Flexion Deformities, Avascular Necrosis of the Femoral Condyle, Chronic Osteoarthritis.
What interventions are being tested in trial NCT03969654?
The interventions under investigation include: PERSONA Total Knee (DEVICE), Vanguard Total Knee (DEVICE), NexGen Total Knee (DEVICE).
Who is sponsoring clinical trial NCT03969654?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03969654 being conducted?
This trial has 5 study locations across Colorado, Illinois, Michigan, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03969654's enrollment target sits among peer trials
181 90th of 197 higher than 108 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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