Multicenter Trial of the Sidus Stem-Free Shoulder Arthroplasty System
Phase: NA
Conditions: Osteoarthritis, Posttraumatic Arthrosis, Rheumatoid Arthritis
Sponsor: Zimmer Biomet

Protocol Synopsis 
 
Title: Multicenter Trial of the Sidus Stem-Free Shoulder Arthroplasty System 
Protocol No.: CIU2012-12E 
Sponsor: Zimmer Inc. 
Objectives: Primary Objectives 
The primary objectives of this study are to evaluate the safety and 
efficacy of the Sidus Stem-Free Shoulder System in unilateral primary 
total shoulder arthroplasty. 
 
Safety will be evaluated by monitoring the frequency and incidence of 
device related adverse events or unanticipated adverse device effects 
(UADEs) in investigational subjects as well as analyzing survivorship 
using revision or intended revision as an endpoint. 
 
Efficacy will be determined by comparing the overall pain and 
functional 
performance 
as 
well 
as 
radiographic 
success 
of 
investigational subjects with those who received the control devices. 
Indication/ 
Target 
Population: 
The Sidus Stem-Free Shoulder System is indicated for uncemented use 
in total shoulder arthroplasty, replacing the shoulder joint of subjects 
suffering from severe pain or disability resulting from one or more of 
the following provided there is adequate bone stock to support the 
fixation of the implants: 
• Osteoarthritis 
• Posttraumatic arthrosis 
• Rheumatoid arthritis without humeral metaphyseal defects 
• Previous shoulder surgeries that do not compromise fixation 
Study Design: Multi-center, prospective, historical controlled. 
Clinical Phase: Investigational Device Exemption Protocol / Pre-market 
Number of 
Subjects: 
95 subjects will be enrolled in this study at up to 15 centers. 
 
 
Revised 20 May 2013 
Confidential 
Zimmer Inc. 
IRB Approved 30 July 2013 
 

Protocol Synopsis 
 
Title: Multicenter Trial of the Sidus Stem-Free Shoulder Arthroplasty System 
Length of Study: Initial follow-up will be 2 years from the date of enrollment completion 
to support product approval.  Intervals include pre-op, operative, 
immediate post-op, 6 weeks, 6 months, 1 year, 2 years, and annually 
until the last subject completes two years of follow-up.   
Investigational 
Device System: 
• Zimmer Anatomical Shoulder Glenoid 
• Sidus Humeral Head 
• Sidus Stem-Free Anchor 
Scores: • American Shoulder and Elbow Society Standardized Shoulder 
Assessment (ASES) 
• SF-12 
• Western Ontario Osteoarthritis Score (WOOS)  
Statistical Analysis Data collected will be summarized and reported to each participating 
Investigator. Statistical analysis is conducted by Zimmer or its designee. 
Primary data analysis will be completed after 2 years of follow-up. 
Documentation: Electronic Data Capture. 
Anticipated 
Enrollment Date 
Zimmer is currently recruiting investigational sites. 
NOTE:  The investigation described by this protocol involves a significant risk device as 
defined by the Investigational Device Exemption (IDE) regulation, Part 812, of the Code 
of Federal Regulations, Food and Drug Administration (FDA).  
 
Sidus Stem-Free 
Shoulder 
Revised 20 May 2013 
Confidential 
Zimmer Inc. 
IRB Approved 30 July 2013