Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
4588 participants
OBSERVATIONAL
2011-06-01
2034-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Enrolled Subjects
Patients recruited from the population undergoing knee arthroplasty as part of standard of care. Patients who meet all the inclusion criteria and none of the exclusion criteria should be presented with an opportunity to undergo the informed consent process.
Optetrak Total Knee System
Total Knee Arthroplasty using Exactech's Optetrak branded components.
Interventions
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Optetrak Total Knee System
Total Knee Arthroplasty using Exactech's Optetrak branded components.
Eligibility Criteria
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Inclusion Criteria
* Patient is skeletally mature
* Patient meets the indications detailed in the applicable product package insert Patient is willing and able to review and sign an informed consent form, if necessary
Exclusion Criteria
* Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used
* Patient is pregnant
* 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
18 Years
ALL
No
Sponsors
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Exactech
INDUSTRY
Responsible Party
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Locations
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Fallon Clinic
Worcester, Massachusetts, United States
Nevada Orthopaedic and Spine Center
Las Vegas, Nevada, United States
Medical University South Carolina
Charleston, South Carolina, United States
Countries
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Other Identifiers
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CR05-007
Identifier Type: -
Identifier Source: org_study_id
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