NCT06627699 · Maxx Orthopedics Inc
Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System
What this study is about
In an effort to satisfy regulatory requirements for post-market surveillance of product safety and effectiveness, a representative sample of patients will be recruited for forward-looking monitoring.
View original scientific description
In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Candidates for this registry must meet ALL of the following criteria:
- Patient is \> 18 years of age
- Patient has failed attempts at non-operative conservative therapy
- Patient has participated in the informed consent process and signed an IRB approved informed consent
- Patient is scheduled to undergo unilateral or bilateral primary TKA of the knee
Exclusion criteria
- Candidates will be excluded from the evaluation if ANY of the following apply:
- Patients with previous TKA, UKA, HTO or knee fusion of the indicated knee
- Patients that have undergone previous surgery of indicated knee for tumor, trauma or fracture
- Evidence of active or suspected (systemic or local) infection at time of surgery
- Other significant disabling problems from the musculoskeletal system than in the knee (i.e.: muscular dystrophy, polio, neuropathic joints)
- Patients with or having; malignancy - active malignancy, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia and systemic lupus erythematosus
- Patients with neuromuscular or neurosensory deficit
- Women who are pregnant
- Prisoner or transient
- Recent history of known narcotic abuse
- Any significant psychological disturbance past or present, that could impair the consent process or ability to complete subject self-report questionnaires
Where
- Leawood, Kansas
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations