Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"

United Orthopedic Corporation (UOC)

Status: Active, not recruiting

Conditions: Osteo Arthritis Knee

Treatments: Device: U2 Knee™ System

Study type: Observational

Funder types: Industry

Identifiers

NCT03060057

03-2017

Details and patient eligibility

About

The purpose of this study is to evaluate both short and long term clinical performance and safety of the commercially available U2 Knee™ System.

Full description

This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total knee arthroplasty (TKA) with the U2 Knee™ System. The study will enroll up to 200 subjects with scheduled pre-discharge, 6-week, 3- and 6-month and up to 5-year annual follow-up visits. Study outcomes will be analyzed and published when 1.) all enrolled and implanted subjects complete their 6-week follow up, 2.) all implanted subjects complete their 2-year follow up, 3.) at the conclusion of the study.

The study will follow GCP guidelines and will be registered on clinicaltrials.gov.

Enrollment: 200 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is between 18 and 75 years of age
2. Subject is indicated for a unilateral total knee arthroplasty (TKA) based on the approved labeling of the device
3. Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative knee
4. Subject is willing and able to provide informed consent to participate in the study;
5. Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits;

Exclusion criteria

• Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.