NCT07391592Active, not recruiting
Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 26 Jan 2026
- Start date
- 18 Aug 2025
- Primary completion date
- 31 Dec 2032
- Lead sponsor
- MicroPort Orthopedics Inc.
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07391592
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 18 Aug 2025 to the primary completion date, 31 Dec 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Subjects without follow-up history
- Subjects not meeting the inclusion criteria
- Contraindications as listed in the IFU
- Currently enrolled in another study that could affect the endpoints of this protocol.
Who the study is looking for
- Subjects \> 18 years of age at the time of surgery
- Subjects who were implanted with the Evolution® NitrX (SKU # listed below) in MicroPort Orthopedics' intended patient population listed within the Instructions for Use (IFU).
- Willing and able to participate in clinical study
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sah Orthopaedic Associates Coordinator of this site? Confirm its status | Fremont | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.