Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert

NCT07391592 | Active Not Recruiting FDA Device

• 1 other identifier: 25DM0004
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthitis; Arthritis Knee; Joint Diseases; Avascular Necrosis; Rheumatoid Arthritis of Knee

Outcome Measures

Primary Outcomes (1)

• Knee Injury and Osteoarthritis Outcome Score- Joint Replacement (KOOS JR)

  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 score ranging from 0 to 100, where 100 indicates the best health and 0 means the worst health.

  10 years

Study Arms (1)

Newly or previously implanted patients

Single center, non-interventional prospective follow-up of newly or previously implanted subjects. Previously implanted subjects must be enrolled within 14 months of the study index surgery. Single study group with either newly or previously implanted patients with all EVOLUTION® NitrX™ components: Non-Porous Keeled Tibia, CS/CR Non-Porous Femur component, and EVOLUTION® MP CS tibial insert

Device: EVOLUTION® NitrX™

Interventions

EVOLUTION® NitrX™ DEVICE

EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert

Newly or previously implanted patients

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Single study group with either newly or previously implanted patients with all Evolution® NitrX components: Non-Porous Keeled Tibia, CS/CR Non-Porous Femur component, and Evolution® MP CS Tibial insert.

You may qualify if:

• 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

You may not qualify if:

• Subjects without follow-up history
• Contraindications as listed in the IFU
• Currently enrolled in another study that could affect the endpoints of this protocol.

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

Study Sites (1)

Sah Orthopaedic Associates

Fremont, California, 94538, United States

Location

MeSH Terms

Conditions

Joint Diseases; Osteonecrosis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Sah, MD

  Sah Orthopaedic Associates, Fremont, California, United States 94538

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 6, 2026
• Study Start: August 18, 2025
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: February 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)