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NCT01542580 · ClinicalTrials.gov registry record
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee
A clinical trial of Rheumatoid Arthritis and Osteoarthritis, sponsored by Zimmer Biomet.
- Active
- Registry status
- 255
- Enrollment target
- 12
- Study locations
NCT01542580: Active study of Rheumatoid Arthritis and Osteoarthritis, sponsored by Zimmer Biomet.
NCT01542580 is a study of Rheumatoid Arthritis and Osteoarthritis that is active but no longer recruiting, run by Zimmer Biomet. The registered enrollment target is 255 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (95% lower). The trial reports 12 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01542580, a study of Rheumatoid Arthritis and Osteoarthritis, is active but no longer recruiting, sponsored by Zimmer Biomet.
- ACTIVE NOT RECRUITING
- Registry status
- 255 participants
- Enrollment target
- 12
- Study locations
Study Summary
The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.
Primary Outcome
Improvement of American Knee Society Knee Score between pre-operative and 2 years post-operative follow up
Conditions Studied
Interventions
- DEVICE Vanguard SSK 360 with PS Bearing
- DEVICE Vanguard SSK 360 with PSC bearing
- DEVICE Vanguard DA 360
- DEVICE Vanguard 360 TiNbN Femur with PS bearing
- DEVICE Vanguard 360 TiNbN Femur with PSC bearing
Study Locations (12)
Other
- University Hopital Pellenberg - Pellenberg
- Aarhus university hospital - Aarhus
- Ch Lyon Sud - Lyon
- Klinik fur Endoprothetik und gelenkchirurgie - Bad Wildbad
- IRCCS Istituto Ortopedico Galeazzi - Milan
- Azienda Ospedaliero Universitaria Pisana - Pisa
- University Hospital Mutua de Terrasa - Terrassa
- Royal Orthopaedic Hospital - Birmingham
Illinois
- Illinois Bone and Joint - Morton Grove
Nevada
- Orthopedic Institute of Henderson - Henderson
Utah
- University of Utah Orthopedic Center - Salt Lake City
Virginia
- OrthoVirginia West End Orthopedic Clinic - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2012-03 |
| Est. Completion | 2031-12 |
What the registry record for NCT01542580 still lists
NCT01542580 is an observational study that tracks outcomes without assigning an intervention. The registered 255 participants enrollment target is mid-sized for trials with a published cap, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (95% lower).
The record links to 6 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 5 interventions - of which Vanguard SSK 360 with PS Bearing is the first listed.
NCT01542580 lists 12 locations in 5 states (Other, Illinois, Nevada).
Frequently Asked Questions
What is clinical trial NCT01542580 about?
NCT01542580 is a clinical study titled "A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee". The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.
What is the current status of trial NCT01542580?
This trial is currently active not recruiting. The enrollment target is 255 participants. The study started on 2012-03. Estimated completion is 2031-12.
What conditions does trial NCT01542580 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Osteoarthritis, Traumatic Arthritis, Complications; Arthroplasty, Post Traumatic Deformity.
What interventions are being tested in trial NCT01542580?
The interventions under investigation include: Vanguard SSK 360 with PS Bearing (DEVICE), Vanguard SSK 360 with PSC bearing (DEVICE), Vanguard DA 360 (DEVICE), Vanguard 360 TiNbN Femur with PS bearing (DEVICE), Vanguard 360 TiNbN Femur with PSC bearing (DEVICE).
Who is sponsoring clinical trial NCT01542580?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01542580 being conducted?
This trial has 12 study locations across Illinois, Nevada, Utah, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01542580's enrollment target sits among peer trials
255 72nd of 197 higher than 126 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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