💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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