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

Part of paid clinical trials in Fremont, California.

Sponsor
MicroPort Orthopedics Inc.
Study ID
NCT04816773
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 27, 2022
Status verified
Mar 2024
Primary completion
Aug 31, 2034
Completion
Jan 31, 2035

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Newly or previously implanted patients
    Multicenter, 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

Primary Outcome Measure

Component Survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia [ Time Frame: 10 years post-operative ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sah Orthopaedic AssociatesFremontCalifornia94538-

Find similar trials in Fremont, CA

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Sah Orthopaedic Associates· Fremont, CA

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