Maxx Orthopedics Knee Implant for Knee Osteoarthritis

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

Recruiting N/A Interventional Study
Knee Osteoarthritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
200 (estimated)
Sponsor
Maxx Orthopedics Inc · Industry
Who this trial is looking for

This trial is looking for people with severe knee osteoarthritis who might need a knee implant. Participants will receive a new type of knee implant and will return to the hospital for follow-up appointments after the surgery.

Are You a Good Fit for This Trial?
Rules you out OsteoporosisMalignancyActive infectionRheumatoid arthritisSickle cell anemia

You may be able to join if

  • I am 18 years of age or older.
  • I have been diagnosed with severe knee osteoarthritis in one knee.
  • My Knee Society Score is between 26 and 74.
  • I can understand and follow the study procedures.
  • I am willing to return for all post-operative follow-ups.
  • I can give written consent to participate.

You may not be able to join if

  • I have a condition that could affect my participation in the study.
  • I have a history of drug or alcohol abuse.
  • I have participated in another clinical study in the past 6 months.
  • I have other serious problems with my muscles or bones.
  • I have known osteoporosis or a previous fracture from it.
  • I have an active malignancy or infection.
  • I am pregnant or breastfeeding.
  • I have had previous surgery on the knee being treated.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 I…
Contacts

Nach Dave, M.S., R.Ph.

732-718-1385

nach.dave@maxxortho.com

CONTACT

Corey Perine, BS, MBA

215-432-4323

corey.perine@maxxortho.com

CONTACT