Optetrak Knee System Post Market Clinical Follow-Up

Exactech

Status: Active, not recruiting

Conditions: Knee Arthroplasty, Total

Treatments: Device: Optetrak Total Knee System

Study type: Observational

Funder types: Industry

Identifiers

NCT05788757

CR05-007

Details and patient eligibility

About

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

Full 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).

Enrollment: 4,588 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,588 participants in 1 patient group

Enrolled Subjects

Description:

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.

Treatment:

Device: Optetrak Total Knee System