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Clinical Studies

Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System – “U-Propel Study” (U-Propel)

ClinicalTrials.gov Identifier: NCT03060057

Introduction

United Orthopedic Corporation 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 enrolling at one (1) location and is ongoing at five (5) locations.

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

Coastal Orthopedics & Sports Medicine | Pain Management

Bradenton, Florida
Office: 941-782-1353 Ext 3450
Study Coordinators:
Chris Scheuerman
cscheuerman@coastalorthopedics.com

Orthoedge
Jacksonville, FL
Study Coordinator: Carol Collins
904-388-1400 x 5012 or 904-301-3252
ccollins@nflsurgeons.com

Orthopaedic Center of Vero Beach
Vero Beach, FL
Study Coordinator:  Nicki Allen
Office:  772-925-9038
Nicki@OrthoSurg.cc

Rubin Institute for Advanced Orthopedics - Sinai Hospital

Baltimore, MD
Study Coordinators:
Nirav Patel, MD
Office: 410-601-8860
nirpatel@lifebridgehealth.org

Taj-Jamal Andrews, MD
Office: 410-601-9592
tandrews@lifebridgehealth.org

Adult Hip and Knee Reconstruction

Trenton Orthopaedic Group at The Rothman Institute

Pennington, New Jersey
Study Coordinator:
Francis Sirch
Office- 609-828-6595
Francis.Sirch@rothmanortho.com

Colorado Joint Replacement
Denver, Colorado
PaulaAbila@Centura.Org
Office: 303-260-2940 | Fax: 720-524-1422

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