Study to Assess Exactech's Guided Personalized Surgery eGPS® in Total Knee Arthroplasty

Exactech

Status: Terminated

Conditions: Osteoarthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02962362

CR15-001

Details and patient eligibility

About

Study to collect outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA).

Full description

The purpose of this study is to collect patient outcomes data for patients who are undergoing an Exactech Optetrak® primary total knee replacement using the Exactech Guided Personalized Surgery (eGPS®) manufactured or distributed by (Exactech, Gainesville, Florida, USA). Patient outcomes data are important for assessing the post-market safety and effectiveness of orthopedic medical devices.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient requires a primary Optetrak Logic Total Knee Arthroplasty
• Patient is skeletally mature with no obvious mechanical defect
• Patient is mentally capable of completing follow-up visits
• Patient is 18 years of age or greater at time of surgery
• Patient will be available for follow-up out to 2 years
• Patient has consented to participate in the clinical study

Exclusion criteria

• 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
• 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