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NOT YET RECRUITING
NCT06627673
NA

MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design

Sponsor: Maxx Orthopedics Inc

View on ClinicalTrials.gov

Summary

The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured from polyether-ether-ketone (PEEK).

Official title: MultiCenter Prospective Parallel Registry Controlled Investigational Device Exemption Clinical Study to Determine Non-Inferiority of the PEEK-OPTIMA™ Femoral Component Versus a CoCr Alloy Femoral Component of Similar Design for TKA

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-01-01

Completion Date

2028-03-01

Last Updated

2024-10-04

Healthy Volunteers

No

Interventions

DEVICE

Total Knee Arthroplasty

Primary Total Knee Arthroplasty with a PEEK femoral component