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NCT07391592 · ClinicalTrials.gov registry record
Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
A clinical trial of Avascular Necrosis and Joint Diseases, sponsored by MicroPort Orthopedics.
- Active
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT07391592: Active study of Avascular Necrosis and Joint Diseases, sponsored by MicroPort Orthopedics.
NCT07391592 is a study of Avascular Necrosis and Joint Diseases that is active but no longer recruiting, run by MicroPort Orthopedics. The registered enrollment target is 100 participants, below the 291-participant average among 24 other Avascular Necrosis trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07391592, a study of Avascular Necrosis and Joint Diseases, is active but no longer recruiting, sponsored by MicroPort Orthopedics.
- ACTIVE NOT RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
MicroPort Orthopedics Inc. (MPO) plans to market the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert globally, including in the European Union (EU). MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur. These components are used along with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert components that is marketed in the European Union (EU). This type of data collection is required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available.
Primary Outcome
KOOS is a validated patient-reported outcome measure designed to assess short- and long- term symptoms and functions in individuals with knee injuries and osteoarthritis. It is a 42-item questionnaire. KOOS JR is its short form, developed using Rasch analysis to provide a more efficient tool for clinical and research use. It has 7 items which measure pain, stiffness and function in daily life. Each item is scored from 0 (none) to 4 (extreme). The raw score (0-28) is converted to an interval scor
Conditions Studied
Interventions
- DEVICE EVOLUTION® NitrX™
Study Locations (1)
California
- Sah Orthopaedic Associates - Fremont
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-08-18 |
| Est. Completion | 2032-12-31 |
What the registry record for NCT07391592 still lists
NCT07391592 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 291-participant average among 24 other Avascular Necrosis trials with a reported enrollment target (66% lower).
The record links to 5 conditions, with Avascular Necrosis appearing as the primary indexed condition, and to 1 intervention - of which EVOLUTION® NitrX™ is the first listed.
NCT07391592 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07391592 about?
NCT07391592 is a clinical study titled "Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert". MicroPort Orthopedics Inc. (MPO) plans to market the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert globally, including in the European Union (EU). MPO is conducting this post market clinical follow-u...
What is the current status of trial NCT07391592?
This trial is currently active not recruiting. The enrollment target is 100 participants. The study started on 2025-08-18. Estimated completion is 2032-12-31.
What conditions does trial NCT07391592 study?
This clinical trial studies the following conditions: Avascular Necrosis, Joint Diseases, Arthritis Knee, Rheumatoid Arthritis of Knee, Osteoarthitis.
What interventions are being tested in trial NCT07391592?
The interventions under investigation include: EVOLUTION® NitrX™ (DEVICE).
Who is sponsoring clinical trial NCT07391592?
This trial is sponsored by MicroPort Orthopedics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07391592 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07391592's enrollment target sits among peer trials
100 17th of 24 higher than 8 of 24 other Avascular Necrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Avascular Necrosis 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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