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

Recruiting now

Conditions studied: Knee Osteoarthristis, Total Knee Anthroplasty

In brief

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.

Key facts

Study ID

NCT06627699

Run by

Maxx Orthopedics Inc

People needed

300

Starts

2025-11-01

Expected to finish

2029-03-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Ascentist Healthcare — Leawood, Kansas, United States (enrolling)
• South Texas Bone & Joint Institute — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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