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

Part of paid clinical trials in Leawood, Kansas.

Sponsor
Maxx Orthopedics Inc
Study ID
NCT06627673
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Total Knee Arthroplasty — DEVICE
    Primary Total Knee Arthroplasty with a PEEK femoral component

Study Details

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).

Key Dates

Start date
Jan 1, 2026
Status verified
Jun 2026
Primary completion
Jan 1, 2029
Completion
Mar 1, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment arm utilizing primary TKA with PEEK femoral component
    This study is a single arm, multi-center, prospective IDE trial. Two hundred (200) patients recruited and consented will receive the PEEK-OPTIMA™ Femoral Component and results will be compared to matched historic controls from the Maxx Orthopedics Freedom Total Knee System product registry (PK-00002 REV-01, WCG IRB# 20241890). Male and female patients 18 years of age or older with Knee Society Score (KSS) of \>25 and \<75 will be eligible for enrollment.

Primary Outcome Measure

Original Knee Society Score [ Time Frame: 24 months post-treatment. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
AscentisLeawoodKansas66211
Palmisano, MD
South Texas Bone and JointSan AntonioTexas78249-

Find similar trials in Leawood, KS

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Ascentis· Leawood, KSSouth Texas Bone and Joint· San Antonio, TX

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