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NCT05630053 · ClinicalTrials.gov registry record · NA
Cemented vs Cementless Persona Keel RCT
A NA study of Rheumatoid Arthritis and Osteoarthritis, sponsored by Zimmer Biomet.
- Active
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 8
- Study locations
NCT05630053: Active NA study of Rheumatoid Arthritis and Osteoarthritis, sponsored by Zimmer Biomet.
NCT05630053 is a NA study of Rheumatoid Arthritis and Osteoarthritis that is active but no longer recruiting, run by Zimmer Biomet. The registered enrollment target is 300 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (94% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05630053, a NA study of Rheumatoid Arthritis and Osteoarthritis, is active but no longer recruiting, sponsored by Zimmer Biomet.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 8
- Study locations
Study Summary
The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.
Primary Outcome
A 12-item PROM was specifically designed and developed to assess function and pain after TKA. This tool is short, reproducible, valid, and sensitive to clinically important changes. Possible scores range from a minimum 0 to maximum 48 points, with higher scores indicating less pain and fewer functional limitations. The primary endpoint is based on the change in OKS scores from baseline to 2-year postoperative follow-up as well as from baseline to 5-year postoperative follow-up.
Conditions Studied
Interventions
- DEVICE Cementless Persona Knee System
- DEVICE Cemented Persona Knee System
Study Locations (8)
Pennsylvania
- Rothman Institute - Bryn Mawr
- Lehigh Valley Hospital - Dickson City - Dickson City
Colorado
- Centura Health - Westminster
Illinois
- Northwestern University - Chicago
Maryland
- Johns Hopkins University - Baltimore
Oregon
- Oregon Health & Science University - Portland
Texas
- Houston Methodist Hospital - Houston
Virginia
- Anderson Orthopaedic Research Institute - Alexandria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-07-25 |
| Est. Completion | 2032-12 |
| Phase | NA |
What the registry record for NCT05630053 still lists
NCT05630053 is an interventional study that assigns participants to a tested intervention. The registered 300 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 (94% lower).
The record links to 9 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Cementless Persona Knee System is the first listed.
NCT05630053 lists 8 locations in 7 states (Pennsylvania, Colorado, Illinois).
Frequently Asked Questions
What is clinical trial NCT05630053 about?
NCT05630053 is a clinical study titled "Cemented vs Cementless Persona Keel RCT". The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.
What is the current status of trial NCT05630053?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2023-07-25. Estimated completion is 2032-12.
What conditions does trial NCT05630053 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Osteoarthritis, Avascular Necrosis, Knee Pain Chronic, Traumatic Arthritis.
What interventions are being tested in trial NCT05630053?
The interventions under investigation include: Cementless Persona Knee System (DEVICE), Cemented Persona Knee System (DEVICE).
Who is sponsoring clinical trial NCT05630053?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05630053 being conducted?
This trial has 8 study locations across Colorado, Illinois, Maryland, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05630053's enrollment target sits among peer trials
300 58th of 197 higher than 138 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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