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

NCT06627673 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-10-04

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

Total Knee Arthroplasty

Primary Total Knee Arthroplasty with a PEEK femoral component

Sponsors & Collaborators

  • Maxx Orthopedics Inc

    lead INDUSTRY

Principal Investigators

  • Asit Shah, MD, PhD · Chief of Orthopedics - Englewood Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2028-01-01
Completion
2028-03-01
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06627673 on ClinicalTrials.gov