ASHCOM Shoulder System and Its Related Instruments - A Multicenter, Prospective, Non-Controlled Post Market Clinical Follow-up Study
Conditions: Rotator Cuff Injuries, Shoulder Pain, Arthropathy; Traumatic, Arthroplasty Complications
Sponsor: Zimmer Biomet

 
 
ASHCOM Shoulder System 
Protocol number: CME2017-67E 
1 
 
 
 
 
 
 
 
ASHCOMTM Shoulder System and Its Related 
Instruments  
A Multicenter, Prospective, Non-Controlled Post Market Clinical 
Follow-up Study 
 
Protocol number: CME2017-67E 
Protocol date: Revision 0, 13 April 2018 
NCT number: NCT04258605 
 
 
 

 
 
ASHCOM Shoulder System 
Protocol number: CME2017-67E 
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1 
STUDY SYNOPSIS 
Complete Protocol Title 
ASHCOMTM Shoulder System and Its Related Instruments 
A Multicenter, Prospective, Non-Controlled Post Market 
Clinical Follow-up Study  
Protocol Number 
CME2017-67E 
Short Protocol Title 
ASHCOMTM Shoulder System and Its Related Instruments 
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 ASHCOM Shoulder 
System and its related instruments by analysis of standard 
scoring systems, radiographs and adverse event records. 
The primary endpoint is defined by the survival of the 
implant at 10 years which is based on removal or intended 
removal of the prosthesis and will be determined using 
Kaplan Meier method. The safety of the system will be 
assessed by monitoring the frequency and incidence of 
adverse events. 
The secondary endpoint of this study is defined by the 
performance and clinical benefits of the ASHCOM Shoulder 
System at 5 years, which is assessed by the Constant and 
Murley score. Assessments of the overall pain, functional 
performance, survival, quality of life and radiographic 
parameters of all enrolled study subjects will be evaluated-
ed in addition. 
Indications/Target Population 
Patients suffering from severe shoulder pain and disability 
indicated for implantation of the ASHCOM Shoulder 
System and who meet all inclusion and none of the 
exclusion criteria. 
Inclusion/Exclusion Criteria 
Inclusion Criteria: 
• 
Patient is capable of understanding the doctor’s 
explanations, following his instructions and is able 
to participate in the follow-up program. 
• 
Patient has given written consent to take part in 
the study by signing the “Patient Consent Form”. 
• 
Patient is 18-80 years of age, inclusive. 
• 
Patient is skeletally mature. 
• 
Patient requires a primary, fracture or revision re-
verse total shoulder replacement for the relief of 
pain and has significant disability due to gross ro-
tator cuff deficiency. 

 
 
ASHCOM Shoulder System 
Protocol number: CME2017-67E 
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• 
Patient’s joint is anatomically and structurally 
suited to receive the selected implants. 
• 
Patient has a functional deltoid muscle. 
 
Exclusion Criteria: 
• 
Patient is unwilling or unable to give consent or to 
comply with the follow-up program. 
• 
Patients who have any condition which would in the 
judgement of the Investigator place the patient at 
undue risk or interfere with the study. Any patient 
who is institutionalized, or is a known drug abuser, 
a known alcoholic or anyone who cannot under-
stand what is required of them. 
• 
Patient is known to be pregnant or breastfeeding. 
• 
Patient is a vulnerable subject. 
• 
Patient meets at least one of the contraindications: 
- 
Signs of infection 
- 
Significant injury to the upper brachial 
plexus 
- 
Non-functional deltoid muscle 
- 
Insufficient quality and/or quantity of gle-
noid or humeral bone 
- 
Any neuromuscular or vascular disease 
compromising the affected limb that 
would endanger the success of the inter-
vention 
Study Design 
A multicenter, prospective, non-controlled post market 
surveillance study 
Clinical Phase 
Post-market 
Sample Size  
97 shoulders. 
Length of Study 
12 years (2 years enrollment plus 10 years follow-up): 
follow-up visits at 3 to 6 months, 1, 2, 5, and 10 years. 
Follow-up surveys at 3 and 7 years post-operatively. 
Materials and Methods 
Case report forms will be completed either in-office or 
hospital at Pre-op, Surgery, Discharge, and at the 3-6 
months and at 1, 2, 5 and 10 year post-operation intervals. 
Patient completed follow-up surveys will be conducted at 
3 and 7 years after surgery. 
Data Collection 
Paper/Electronic 
Statistical Reporting 
Data collected will be summarized and reported to each 
participating investigator.  Statistical analysis will be 

 
 
ASHCOM Shoulder System 
Protocol number: CME2017-67E 
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conducted by Zimmer Biomet or its designee. Survivorship 
will be evaluated using Kaplan-Meier. 
Scores/Performance Assessments 
Constant-Murley, Oxford Shoulder Score, EuroQol (EQ-5D), 
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. 
 
 
 

 
 
ASHCOM Shoulder System 
Protocol number: CME2017-67E 
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2 
STATISTICAL ANALYSIS PLAN 
2.1 Sample Size 
 
This study is designed to have an alpha error no greater than 0.05. Based on an assumed survivorship 
of 86% at ten years, a sample size of n = 58 at ten years has at least 80% probability to compute a 
one-sided 95% lower confidence bound on the survivorship of the device with a half-width precision 
of 0.09. Sample size calculation was computed using SAS 9.4, Proc Power. To account for loss-to-fol-
low-up estimated at 5% per year, 97 patients need to be enrolled in the study to have 58 patients at 
the end of ten years.   
The half-width precision of 0.09 allows us to set a lower bound on survivorship of 9% from the ex-
pected survivorship performance of 86% at 10 years. This detectable change of 9% is analogous to 
non-inferiority margins that approach 10% in regulated studies 
 
2.2 Statistical Analysis 
 
Continuous data (e.g. age, BMI, Oxford Shoulder Score) will be reported using mean, standard 
deviation, median, and range. Comparisons between continuous baseline and interim patient visits 
will be performed using standard statistical tests and will be chosen as appropriate for the scale and 
distribution of the measures being analyzed. For example, a t-test, Wilcoxon test, or one-way ANOVA 
(as appropriate) may be performed to assess differences. Comparisons between preoperative and 
follow-up visit scores will use two-sided comparisons with α = 0.05, with no adjustment for multiple 
comparisons. 
Categorical data (e.g. gender) will be reported using frequency and percentage.  Comparisons 
between categorical baseline and interim patient visits will be performed using standard statistical 
tests and will be chosen as appropriate for the scale and distribution of the measures being analyzed.