Optetrak Knee System Post Market Clinical Follow-Up
Active, not recruiting
- Conditions
- Knee Arthroplasty, Total
- Interventions
- Device: Optetrak Total Knee System
- Registration Number
- NCT05788757
- Lead Sponsor
- Exactech
- Brief Summary
A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System
- Detailed Description
Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive a Optetrak® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 4588
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
Exclusion Criteria
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Enrolled Subjects Optetrak Total Knee System 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.
- Primary Outcome Measures
Name Time Method Knee Society Score annually through study completion, maximum of 10-years (KSS) - validated outcome score
Hospital for Special Surgery Knee Score annually through study completion, maximum of 10-years (HSS) - validated outcome score
Oxford Knee Score annually through study completion, maximum of 10-years (OKS) - validated outcome score
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
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