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NCT03048201 · ClinicalTrials.gov registry record · NA
Physica System Total Knee Replacement Registry Study
A NA study of Rheumatoid Arthritis and Osteoarthritis, Knee, sponsored by Limacorporate S.p.a.
- Recruiting
- Registry status
- NA
- Development phase
- 800
- Enrollment target
- 5
- Study locations
NCT03048201: Recruiting NA study of Rheumatoid Arthritis and Osteoarthritis, Knee, sponsored by Limacorporate S.p.a.
NCT03048201 is a NA study of Rheumatoid Arthritis and Osteoarthritis, Knee that is actively recruiting participants, run by Limacorporate S.p.a. The registered enrollment target is 800 participants, below the 4,687-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (83% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03048201, a NA study of Rheumatoid Arthritis and Osteoarthritis, Knee, is actively recruiting participants, sponsored by Limacorporate S.p.a.
- RECRUITING
- Registry status
- NA
- Development phase
- 800 participants
- Enrollment target
- 5
- Study locations
Study Summary
The primary objective of this study is to obtain long-term implant survivorship (out to 10 years) and to assess clinical, patient-reported outcome measures, and radiographic data for the commercially available Physica system. For ancillary arm, from baseline to 5-year follow-up.
Primary Outcome
The primary endpoint is the definition of the implant survivorship of the study device to 10 years after the total knee replacement surgery.
Conditions Studied
Interventions
- DEVICE Physica Kinematic Retaining Knee System
- DEVICE Physica Cruciate Retaining Knee System
- DEVICE Physica Posterior Stabilized Knee System
- DEVICE Physica Cruciate Retaining Knee System with LMC Liner
Study Locations (5)
California
- Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg - Rancho Mirage
Florida
- The Orthopedics Clinic - Daytona Beach
Illinois
- Rush Castle Orthopaedics - Aurora
New York
- Syracuse Orthopedic Specialists - Syracuse
Oklahoma
- Joint Reconstructive Specialist - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2017-03-24 |
| Est. Completion | 2030-03 |
| Phase | NA |
What NCT03048201 shows while recruiting
NCT03048201 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, below the 4,687-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (83% lower).
The record links to 6 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 4 interventions - of which Physica Kinematic Retaining Knee System is the first listed.
NCT03048201 lists 5 locations in 5 states (California, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT03048201 about?
NCT03048201 is a clinical study titled "Physica System Total Knee Replacement Registry Study". The primary objective of this study is to obtain long-term implant survivorship (out to 10 years) and to assess clinical, patient-reported outcome measures, and radiographic data for the commercially available Physica system. For ancillary arm, from baseline to 5-year follow-up.
What is the current status of trial NCT03048201?
This trial is currently recruiting. It is a NA study. The enrollment target is 800 participants. The study started on 2017-03-24. Estimated completion is 2030-03.
What conditions does trial NCT03048201 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Osteoarthritis, Knee, Avascular Necrosis, Traumatic Arthritis, Degenerative Joint Disease of Knee.
What interventions are being tested in trial NCT03048201?
The interventions under investigation include: Physica Kinematic Retaining Knee System (DEVICE), Physica Cruciate Retaining Knee System (DEVICE), Physica Posterior Stabilized Knee System (DEVICE), Physica Cruciate Retaining Knee System with LMC Liner (DEVICE).
Who is sponsoring clinical trial NCT03048201?
This trial is sponsored by Limacorporate S.p.a, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03048201 being conducted?
This trial has 5 study locations across California, Florida, Illinois, New York, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03048201's enrollment target sits among peer trials
800 28th of 197 higher than 170 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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