Case Study - Total Hip Replacement

Introduction

United Orthopedic Corporation (UOC) is sponsoring a post market study (PMS) to evaluate the clinical performance of the U-Motion II+ Acetabular System and the UTF Reduced Stem, associated surgical instruments, and surgical technique. The devices used in this PMS 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

Despite advances in total hip arthroplasty (THA), postoperative dislocation, bearing wear, and insufficient range of motion are still challenging problems, especially for younger, more active individuals. The U-Motion II+ Acetabular System and UTF Reduced Stem are designed to address these issues by using improved implant materials including a BIOLOX delta ceramic head and a highly cross-linked polyethylene (XPE) liner. With this unique material technology, the U-Motion II+ Acetabular System offers larger femoral head sizes to improve hip flexion and to reduce the risk of joint dislocation. The UTF Reduced Stem offers refined proximal M/L width to maximize metaphyseal fitting, a broach-only technique to minimize bone removal and a reduced distal width to accommodate all types of femoral canal.

Intended Use of the Study Device

The U-Motion II+ Acetabular System and the UTF Reduced Stem used in this study are cleared by the U.S. Food and Drug Administration (FDA) for commercial distribution.

The U-Motion II+ Acetabular System and UTF Reduced Stem are intended for use in subjects who require primary THA for reduction or relief of pain and/or improved hip function.

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 five (5) locations throughout the US. To learn more about qualifying as a patient for this study, please contact UOC USA, INC. or a study site located near you (study sites listed below).

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:

Hospital for Special Surgery
New York, NY
Study Coordinator: Rachelle Morgenstern
212-606-1128
morgensternr@hss.edu

Orthopedic Associates of Dayton
Dayton, Ohio
Study Coordinator: Julie Weller
(937)280-4988
juliew@orthodayton.net

Kenosha Orthopedics
Kenosha, Wisconsin
Study Coordinator: Elliot Simon
262-656-3150
Elliot.Simon@uhsi.org

Jacksonville Orthopedic Institute
Jacksonville, FL
Study Coordinator: Carol Collins
904-301-3252
ccollins@joi.net

University of Pennsylvania
Philadelphia, PA
Study Coordinator: Helena Moses
(215) 662-3340
Helena.Moses@uphs.upenn.edu