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NCT06627699Recruiting

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

Maxx Orthopedics Inc

Start Date

11/1/2025

Completion Date

3/1/2029

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.

Detailed 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. To maintain equal site distribution per device, patient recruitment will include up to a total of twenty (20) registry sites and thirty (30) primary TKA candidates per site / surgeon for a total of 600 registry patients. A total of no more than 200 patients across all sites will be recruited per level of constraint (e.g.: 200 CR, 200:PS, 200:UC) for this registry with a 10-month accrual target from study initiation per site (\~3 patients consented / month).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Total Knee Arthroplasty

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Conditions

Knee OsteoarthristisTotal Knee Anthroplasty

Locations

Ascentist Healthcare

Leawood, Kansas 66211

United States

South Texas Bone & Joint Institute

San Antonio, Texas 78249

United States