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ClinicalTrials.gov Identifier: NCT02962362
Recruitment Status : Unknown
Verified November 2016 by Exactech. Recruitment status was: Recruiting
The purpose of this study is to collect patient outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA). Patient outcomes data are important for assessing the post-market safety and effectiveness of orthopedic medical devices.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
One hundred (100) subjects enrolled up to 4 sites. All subjects will be screened, enrolled and evaluated prospectively and be followed for up to two years. In the event a subject is enrolled and does not have surgery, additional patients may be screened and enrolled to reach the 100 subjects.
Patient requires a primary Optetrak Logic Total Knee Arthroplasty
Patient is skeletally mature with no obvious mechanical defect
Patient is mentally capable of completing follow-up visits
Patient is 18 years of age or greater at time of surgery
Patient will be available for follow-up out to 2 years
Patient has consented to participate in the clinical study
Patient has a mental or physical condition that may invalidate evaluation of the data
Patient is a prisoner
Surgery is contraindicated according to the applicable product package insert
Patient has a local or systemic infection
Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used