NCT01390038|CompletedPhase 3Results
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Sponsor study identifier
interventional
157
1 country
14
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
Actual (reported)Study Completion
December 2014
Actual (reported)The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 26, 2011
Actual (reported)July 2011
Date type not reportedThis date has not been verified as actual or estimated.
July 8, 2011
Actual (reported)November 2014
Actual (reported)December 2014
Actual (reported)April 14, 2016
Actual (reported)Device Success Rate
A subject is a Patient Success at 24-months if: 1. There is NO continuous radiolucent line around the prosthesis; and 2. The adjusted Constant Score is \> 85 (successful outcome); and 3. They did not have revision surgery; and 4. They did not have a system-related serious adverse event.
24 months
Quality of Life
24 months
Range of Motion
24 months
Strength
24 months
Device Parameters
24 months
American Shoulder and Elbow Surgeon Score
24 Months
The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Total shoulder arthroplasty system
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Saint Agnes Medical Center
Fresno, California, 93720, United States
Grossmont/Sharp Hospital
La Mesa, California, 91942, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Rush Hospital
Chicago, Illinois, 60612, United States
Beverly Hills Orthopaedic Surgery
Beverly Hills, Michigan, 48025, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Sports and Orthopaedic Specialists
Edina, Minnesota, 55439, United States
157 participants (actual enrollment reported by the registry).
First Submitted
May 26, 2011
First Posted
July 8, 2011
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
University of Missouri-Columbia
Columbia, Missouri, 65212, United States
Bassett Healthcare Network Research Institute
Cooperstown, New York, 13326, United States
Cleveland Clinic
Euclid, Ohio, 44119, United States
The Center
Bend, Oregon, 97701, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Knoxville Orthopaedic Clinic
Knoxville, Tennessee, 37917, United States
Aurora Medical Center - Grafton
Grafton, Wisconsin, 53024, United States
Primary Completion
November 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
April 25, 2023
Results First Posted
April 14, 2016
Record last verified: 2023-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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