NCT06627699 Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System
| NCT ID | NCT06627699 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maxx Orthopedics Inc |
| Condition | Knee Osteoarthristis |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-11-01 with a primary completion date of 2028-11-01.
⚠ 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
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.
Eligibility Criteria
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
Contact & Investigator
Asit Shah, MD, PhD
STUDY CHAIR
Chief of Orthopedics, Englewood Hospital
Frequently Asked Questions
Who can join the NCT06627699 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Osteoarthristis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06627699 currently recruiting?
Yes, NCT06627699 is actively recruiting participants. Contact the research team at nach.dave@maxxortho.com for enrollment information.
Where is the NCT06627699 trial being conducted?
This trial is being conducted at Leawood, United States, San Antonio, United States.
Who is sponsoring the NCT06627699 clinical trial?
NCT06627699 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 300 participants.