Optetrak Knee System Post Market Clinical Follow-Up

A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System

A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System

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).

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