ClinicalTrials.gov Identifier: NCT02761499
Introduction
United Orthopedic Corporation 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
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
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@unitedorthopedic.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
Office: 212-606-1128
morgensternr@hss.edu
Renee Ren
Office: 64716390
renyi@hss.edu
Orthopedic Associates of Dayton
Dayton, Ohio
Study Coordinator:
Zachary Baum
zbaum@orthodayton.net
Froedtert South
Kenosha, Wisconsin
Study Coordinator: Elliot Simon
262-656-3150
Elliot.Simon@uhsi.org
Orthoedge
Jacksonville, FL
Study Coordinator: Carol Collins
904-301-3252
ccollins@nflsurgeons.com
University of Pennsylvania
Philadelphia, PA
Study Coordinator: Helena Moses
(215) 662-3340
Helena.Moses@uphs.upenn.edu