RecruitingKnee Osteoarthritis
MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: Maxx Orthopedics Inc
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06627673 · last updated 2026-06-26