Case Study - Total Knee Replacement

Introduction

United Orthopedic Corporation (UOC) is sponsoring a post market study (PAS) to evaluate the clinical performance of the U2 Knee™ System along with the associated surgical instruments, and surgical technique. The device used in this PAS are cleared to market by the Food and Drug Administration (FDA) and will be used in accordance with the cleared labeling and indications for use.

Rationale

With its 155-degree high-flexion design and unique bone preserving properties, the U2 Knee™ system is designed to reduce pain and/or improve overall knee function in skeletally mature patients who suffer from rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, and certain other debilitating conditions of the knee. Innovative instrument set also supports minimally invasive surgical techniques, and offers predictable accuracy and precision during implant preparation and placement.

Intended Use of the Study Device

The U2 Knee™ System used in this study is cleared by the U.S. Food and Drug Administration (FDA) for commercial distribution.

The U2 Knee™ System is intended for use in subjects who require primary total knee arthroplasty (TKA) for reduction of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle.

The U2 Knee™ System is provided sterile and intended for single use only.

Duration of the Study

The study provides for up to 200 patients being enrolled at up to 10 sites. The patients will be evaluated at 10 visits: baseline, procedure/ discharge and 6 weeks, 3 months, 6 months, 12 months, and 24 months post treatment for primary analysis and annually up to 5 years for secondary long-term follow-up.

Clinical Trial Locations and Additional Sites

Currently, the study is ongoing at one (1) location. To learn more about qualifying as a patient in the study, please contact UOC USA, INC. or a study site located new you.

We are also currently recruiting additional clinical sites. If you are interested in participating as an investigator surgeon please contact:

Mindy Carlson
mindy.carlson@uocusa.com


The following locations are the current active clinical study sites for this study:

Coastal Orthopedics & Sports Medicine | Pain Management
Bradenton, Florida
Study Coordinator: Christina Scheuerman RN, BSN, CCRC
Office: 941-782-1353 Ext 3450
cscheuerman@coastalorthopedics.com

Jacksonville Orthopaedic Institute-Riverside Division
Jacksonville, Florida
Study Coordinator: Carol Collins, RT (R)
904-388-1400 x 5012 or 904-301-3252
ccollins@joi.net