Optetrak Knee System Post Market Clinical Follow-Up
Recruiting at 2 trial locations
PH
AK
Overseen ByAlex Knisely
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Exactech
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System
Eligibility Criteria
Inclusion Criteria
Patient is indicated for knee replacement, or has already undergone knee replacement, with a device manufactured or distributed by Exactech
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive the Optetrak knee prosthesis as part of standard care
Follow-up
Participants are monitored for safety and effectiveness after receiving the knee prosthesis
Annually through study completion, maximum of 10 years
Treatment Details
Interventions
- Optetrak Total Knee System
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Enrolled SubjectsExperimental Treatment1 Intervention
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.
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Who Is Running the Clinical Trial?
Exactech
Lead Sponsor
Trials
17
Recruited
30,400+
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