NCT06627673 MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design
| NCT ID | NCT06627673 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maxx Orthopedics Inc |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-01-01 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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 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 Criteria: * 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.
Contact & Investigator
Asit Shah, MD, PhD
STUDY CHAIR
Chief of Orthopedics - Englewood Hospital
Frequently Asked Questions
Who can join the NCT06627673 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06627673 currently recruiting?
Yes, NCT06627673 is actively recruiting participants. Contact the research team at nach.dave@maxxortho.com for enrollment information.
Where is the NCT06627673 trial being conducted?
This trial is being conducted at Leawood, United States, San Antonio, United States.
Who is sponsoring the NCT06627673 clinical trial?
NCT06627673 is sponsored by Maxx Orthopedics Inc. The principal investigator is Asit Shah, MD, PhD at Chief of Orthopedics - Englewood Hospital. The trial plans to enroll 200 participants.