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PEEK-OPTIMA™ Femoral Component for Knee Osteoarthritis

This study is testing a new type of knee implant called the PEEK-OPTIMA™ femoral component, which is part of the Maxx Orthopedics, Freedom Total Knee® System. This component is made from a special plastic called PEEK. Researchers want to see how safe and effective this PEEK component is for people with severe knee osteoarthritis. You might be able to join if you are 18 or older, have painful knee osteoarthritis in one knee, and your Knee Society Score (a measure of knee function) is between 25 and 75. The main goal is to see how your knee function improves after 24 months using the Original Knee Society Score. The study status is currently unclear, and they plan to enroll 200 participants.

Study design
This is an interventional study where all participants will receive the Freedom Total Knee System with the PEEK femoral component. It plans to enroll 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your knee function will be measured at 24 months after your treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06627673

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

Recruiting
NAAges 18+InterventionalBasic science
Maxx Orthopedics Inc
~200 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:Total Knee Arthroplasty

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Original Knee Society Score
Measured over 24 months post-treatment.

Conditions

Knee Osteoarthritis

Explore related trials

Osteoarthritis of knee

NCT06627673

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ascentis

    Leawood, Kansasno site contact published

    Recruiting

  • South Texas Bone and Joint

    San Antonio, Texasno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Nach Dave, M.S., R.Ph.
[email protected]
732-718-1385
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Male and female subjects 18 years of age or older.
Subjects with a primary diagnosis of end-stage symptomatic unilateral primary knee osteoarthritis.
Subjects with a pre-operative Knee Society Score (KSS) Knee score of \>25 and \<75.
Subjects who, in the opinion of the Investigator, can understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Subjects who can give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

Exclusion

Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
Subjects who have participated in a clinical study with an investigational product in the last 6 months.
Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e.: muscular dystrophy, polio, neuropathic joints).
Subjects with known osteoporosis and/or previous history of fracture related to osteoporosis.
Subjects with a current or active history of malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed, rheumatoid arthritis, sickle cell anemia, and systemic lupus erythematosus.
Subjects defined by the Investigator as American Society of Anesthesiologists (ASA) Grade III or IV.
Subjects who have a neuromuscular or neurosensory deficit.
Female subjects who are pregnant or lactating.
Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.
Subjects with primary or secondary diagnosis of inflammatory or traumatic arthritis.
Subjects with a fixed flexion deformity of over 20 degrees.
Subjects with recurvatum (definition: hyperextension ≥ 5 degrees).
Subjects who have previously undergone surgery on the indicated knee including total knee arthroplasty, patellofemoral arthroplasty, or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, fusion, open reduction and internal fixation.
Subjects that have undergone, or scheduled to undergo, contralateral total knee arthroplasty or unicondylar knee arthroplasty within ±1 year from the study surgical procedure.
Evidence of active or suspected (systemic or local) infection at time of surgery.

What this trial measures

  • Original Knee Society Score24 months post-treatment.

    The Knee Society Score rating system was first introduced during the late 1980's and has become the standard clinical evaluation system for reporting results for patients undergoing Total Knee Arthroplasty. Most major journals strongly encourage that total knee manuscripts include Knee Society Score rating scores as part of the result section. The Knee Society Score consists of points given for pain, range of motion, and stability. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices. The Knee Society Score is usually reported as the two scores, "Knee Score" and "Function Score," rather than a summation score. The KSS score has a maximum of 100 points for each domain (Knee and Function).