Anaverse™ Glenoid System and Its Instrumentation - Retrospective and Prospective, Non-Controlled Post Market Clinical Follow-Up Study
Conditions: Rotator Cuff Injuries, Shoulder Pain, Arthropathy, Arthroplasty Complications
Sponsor: Zimmer Biomet

 
 
Anaverse Glenoid System 
Protocol number: CME2017-11E 
1 
 
 
 
 
 
 
 
Anaverse™ Glenoid System and its 
instrumentation 
Retrospective and Prospective, Non-Controlled Post Market Clinical 
Follow-Up Study 
 
Protocol number: CME2017-11E 
Protocol date: Revision 1.1, 28.03.2022 
NCT number: NCT05215600 
 
 
 

 
 
Anaverse Glenoid System 
Protocol number: CME2017-11E 
2 
1 
STUDY SYNOPSIS 
Complete Protocol Title 
Anaverse™ Glenoid System and its instrumentation - 
Retrospective and Prospective, Non-Controlled Post Market 
Clinical Follow-Up Study 
Protocol Number 
CME2017-11E 
Short Protocol Title 
Anaverse™ Glenoid System and its instrumentation 
Sponsor 
Zimmer GmbH, Zählerweg 4, 6300 Zug, Switzerland 
Manufacturer 
Zimmer Switzerland Manufacturing GmbH, Sulzerallee 8, 
8404 Winterthur, Switzerland 
Study Device(s) 
Anaverse™ Glenoid System 
Study Objectives/Endpoints 
The objectives of this study are to confirm safety, 
performance and clinical benefits of the Anaverse™ Glenoid 
System and its instrumentation by analysis of standard 
scoring systems, radiographs and adverse event records. 
The safety of the system will be assessed by monitoring the 
frequency and incidence of adverse events. 
The performance and clinical benefits will be evaluated by 
assessment of the overall pain and functional performance, 
survival, and radiographic parameters of all enrolled study 
subjects. 
The primary endpoint is defined by the survival of the 
implant system at 2 years which is based on removal or 
intended removal of the Anaverse™ Glenoid System 
baseplate and will be determined by using the Kaplan Meier 
method. 
Indications/Target Population 
Patients suffering from severe shoulder pain and disability 
indicated for implantation of the Anaverse™ Glenoid System 
in cases of total shoulder arthroplasty in reversed 
configuration. Patients who underwent total shoulder 
arthroplasty conversion from anatomical to reversed will be 
enrolled for subgroup analysis. 
Patients must meet all inclusion and none of the exclusion 
criteria. 
The reversed configuration of the Anaverse Glenoid System 
is indicated for patients with significant shoulder disability 
due to gross and irreparable rotator cuff deficiency. A 
functional deltoid muscle is necessary to use the device. 
The conversion from anatomical to reversed configuration is 
indicated for patients that were implanted with the system 
in the anatomical configuration and that present irreparable 
rotator cuff and superior migration of the humeral head, 
leading to a reduction in sub-acromial space. 
Inclusion/Exclusion Criteria 
Inclusion and exclusion criteria reflect indications and 
contraindications reported on the device instructions for 
use (IFU). 

 
 
Anaverse Glenoid System 
Protocol number: CME2017-11E 
3 
Inclusion criteria: 
• 
Patient is 18-75 years of age, inclusive. 
• 
Patient is skeletally mature. 
• 
Patient is capable of understanding the doctor’s 
explanations, following his instructions and is able to 
participate in the follow-up program. 
• 
Patient must have signed EC-approved informed 
consent. 
• 
Patient requires a primary reversed total shoulder 
arthroplasty or a conversion from anatomical to 
reversed to relieve pain and restore the joint function. 
• 
Patient has adequate quality and quantity of bone stock 
to support the prosthesis. 
• 
Patient meets at least one of the following indications: 
o Advanced wear and tear of the shoulder joint 
resulting from degenerative, posttraumatic or 
rheumatoid arthritis 
o Conditions consequent to earlier operations 
o Omarthrosis or Osteoarthritis 
o Rheumatoid arthritis 
o Total joint reconstruction following trauma 
• 
Patient has significant shoulder disability due to gross 
and irreparable rotator cuff deficiency. A functional 
deltoid muscle is necessary to use the device. 
• 
Patient underwent reverse total shoulder 
reconstruction with the Anaverse Glenoid System 
before the date of site initiation. 
• 
Patient has demographic, pre-operative evaluation, 
operative report and device information available. 
Specific inclusion criteria for Conversion from Anatomical to 
Reversed Configuration: 
• 
Surgery was performed with the Anaverse Glenoid 
System in a previously available anatomical 
configuration. 
• 
Irreparable rotator cuff with superior migration of the 
humeral head, leading to a reduction in sub-acromial 
space. 
• 
Superior tilt of the Anaverse Glenoid Baseplate not 
exceeding 15° compared to scapular axis. 
No evidence of mechanical or fixation failure of the 
Baseplate, TM Pegs or DPSC Screws, obtained pre- or intra-
operatively, which would compromise the success of the 
conversion surgery. 
 
Exclusion criteria: 
• 
Patient is unwilling or unable to give consent or to 
comply with the follow-up program. 
• 
Patient has any condition which would in the judgment 

 
 
Anaverse Glenoid System 
Protocol number: CME2017-11E 
4 
of the Investigator place the patient at undue risk or 
interfere with the study. 
• 
Patient is known to be pregnant or breastfeeding. 
• 
Patient is a vulnerable subject (prisoner, mentally 
incompetent or unable to understand what 
participation to the study entails, a known alcohol or 
drug abuser, anticipated to be noncompliant). 
• 
Patient has any physical conditions that would impair 
adequate implant support and/or prevent the use of an 
appropriately sized implant. 
• 
Patient has any sign of infection (affecting the shoulder 
joint or in its proximity). 
• 
Patient has glenoid presenting with large defects due to 
erosion, which would lead to insufficient bony support 
or malalignment of the devices. 
• 
Patient is skeletally immature. 
• 
Patient has any sign of neuromuscular compromise 
(excluding rotator cuff tear). 
• 
Patient has vascular deficiency in the affected limb in 
sufficient degree to endanger the success of the 
intervention. 
• 
Patient has absence of musculo-ligamentous supporting 
structures. 
• 
Patient suffers from joint neuropathy or other 
conditions that may lead to inadequate skeletal fixation. 
• 
Patient has significant injury to the upper brachial 
plexus. 
• 
Patient has non-functional deltoid muscle. 
Specific exclusion criteria for Conversion from Anatomical to 
Reversed Configuration: 
• 
Unstable fixation of Baseplate after removal of PE Liner. 
• 
Superior tilt of Baseplate exceeding 15° compared to 
scapular axis 
• 
Superior malposition of the Baseplate which would 
prevent correct assembly of the Glenosphere. 
• 
Evidence of mechanical or fixation failure of the 
Baseplate, TM Pegs or DPSC Screws, obtained pre- or 
intra-operatively, which would compromise the success 
of the conversion surgery. 
Study Design 
Retrospective and prospective, non-controlled post market 
surveillance study. 
Clinical Phase 
Post-market 
Sample Size  
30 shoulders. 

 
 
Anaverse Glenoid System 
Protocol number: CME2017-11E 
5 
Length of Study 
3 years (1 year of enrollment plus 2 years of follow-up): 
follow-up visits at 6 weeks, 1 and 2 years postoperatively. 
Materials and Methods 
Case report forms will be completed either in-office or 
hospital at Pre-op, Surgery, Discharge, and at the 6 weeks, 1 
year, and 2 year post-operation intervals. 
Data Collection 
Paper/Electronic 
Statistical Reporting 
Data collected will be summarized and reported to each 
participating investigator.  Statistical analysis will be 
conducted by Zimmer Biomet or its designee. Survivorship 
will be evaluated using Kaplan-Meier. Categorical data, such 
as incidences and device-related complications, will be 
summarized using counts and percentages with 95% 
confidence intervals. Continuous data, such as patient 
satisfaction scores, will be summarized by using means, 
medians, standard deviations, minimum, maximums, and 
95% confidence intervals. Patient demographics, such as 
age and gender, will also be similarly summarized and 
reported on. Patients who underwent reoperations and/or 
revisions of components other than the baseplate will also 
be included in the statistical analysis. This subpopulation is 
not statistically powered; however, it will be included in the 
statistical analysis. 
Statistical analyses will be performed using SAS 9.4. The 
binomial distribution tests will have 80% probability of 
computing a two-sided 90% confidence interval on 
survivorship of each device with a non-inferiority margin of 
0.09. 
Scores/Performance 
Assessments 
Constant-Murley, Patient Satisfaction, Revisions, Adverse 
Events, Radiographic Assessment. 
Standards 
The PMCF is compliant with the below: 
• 
ISO 14155: 2020 - Clinical investigation of medical 
devices for human subjects - Good clinical practice. 
• 
The Declaration of Helsinki (DoH) – Ethical principles for 
medical research involving human subjects. 
• 
European Regulation (EU) 2017/745. 
Study Funding 
Funding for this clinical study is made available by Zimmer 
Biomet to support clinical data collection, IRB/EC review 
fees and other expenses associated with the conduct and 
execution of this study protocol as outlined in the fully 
executed Clinical Trial Agreement. .