Total Knee Replacement: post-market safety and effectiveness registry

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry collects prospective data from patients undergoing primary total knee arthroplasty with the Freedom Total Knee system to monitor safety and performance after market release. Up to 20 registry sites will enroll about 600 patients to ensure even site distribution and robust real-world information. Data are gathered over a defined accrual period with standardized follow-up to satisfy regulatory surveillance requirements. The study includes adults undergoing unilateral or bilateral primary knee replacement and excludes those with prior knee implants or certain comorbid conditions to focus on typical primary TKA outcomes.

Why it matters

Who can join: the full rules

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 it's running

• Ascentist Healthcare
  Leawood, Kansas, United States Recruiting
• South Texas Bone & Joint Institute
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Nach Dave, MS, RPh
• Email: nach.dave@maxxortho.com
• Phone: 732-718-1385

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.