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ROSA Robot Used in Total Knee Replacement Post Market Study
NCT03969654 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03969654
The ClinicalTrials.gov registry entry for NCT03969654 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zimmer Biomet, which has 102 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03969654 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Colorado, Illinois, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03969654?
This trial is sponsored by Zimmer Biomet, which has 102 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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