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Recruiting NCT06627699

Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System

Conditions: Knee Osteoarthristis, Total Knee Anthroplasty

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 300
Sponsor: Maxx Orthopedics Inc

Location: Ascentist Healthcare Leawood Kansas

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06627699). StuddyBuddy aggregates publicly available trial information.