A Randomised, Multicentre, Prospective, Non-inferiority Clinical Study Analysing Outcomes of a Cemented Pegged Polyethylene Glenoid Component Versus a Hybrid Polyethylene and Trabecular Titanium Glenoid Component in Patients With Osteoarthritis Treated With an Anatomical SMR Stemless Shoulder Arthroplasty
Phase: NA
Conditions: Glenohumeral Osteoarthritis
Sponsor: Spaarne Gasthuis

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RESEARCH PROTOCOL 
 
 
Hybrid versus poly-ethylene glenoid in stemless 
anatomical shoulder arthroplasty: A multicentre, 
prospective, non-inferiority randomized controlled 
trial. 
 
 
 
 
Short Title: poly versus hybrid glenoid in stemless aTSA 
Protocol ID: 
Date/Version 01-11-2024, version 5 
 
Tjarco Alta: Orthopaedic Surgeon 
Michel van den Bekerom: Orthopaedic Surgeon 
Guus Janus: Orthopaedic Surgeon 
Paul Kuijer: Human Movement Scientist \ 
Joost Willems: Orthopaedic Surgeon 
A. Akchi Masjediy: Coordinating 
Investigator 
Olivier van der Meijden: Orthopaedic Surgeon 
Arthur van Noort: Orthopaedic Surgeon 
Marjolein Schager: Research Coordinator 
Inger Sierevelt: Clinical Epidemiologist 
 
Sponsor 
Spaarne Gasthuis, 
Spaarnepoort 1 
2134 TM 
Hoofddorp 
 
Financial support 
Limacorporate spa 
Via Nazionale 52 
33038 Villanove di San Daniele (Udine), Italy 

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PROTOCOL TITLE 
A randomised, multicentre, prospective, non-inferiority clinical study analysing outcomes of a cemented 
pegged polyethylene glenoid component versus a hybrid polyethylene and trabecular titanium glenoid 
component in patients with osteoarthritis treated with an anatomical SMR stemless shoulder arthroplasty 
 
Protocol ID 
A randomised, multicentre, prospective, non-
inferiority clinical study analysing outcomes of a 
cemented pegged polyethylene glenoid component 
versus a hybrid TT glenoid component in patients 
with osteoarthritis treated with an anatomical 
SMR stemless shoulder arthroplasty 
Short title 
Poly vs Hybrid Glenoid in stemless aTSA 
EudraCT number 
Version 
Version 5 
Date 
01-11-2024 
Coordinating investigator/project Joost I.P. Willems MD 
leader 
p/a Medische Kliniek Velsen 
Leeghwaterweg 1b 
1951 NA Velsen Noord 
Tel. 085 - 0600855 
Principal investigator (in Dutch: 
A. van Noort MD PhD 
hoofdonderzoeker/uitvoerder) 
p/a Spaarne Gasthuis 
Spaarnepoort 1 
2134 TM Hoofddorp 
Tel. 023 – 224 64 59 
Independent expert 
J. van Aken MD 
Rheumatologist 
Spaarne Gasthuis 
jvanaken@spaarnegasthuis.nl 

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PROTOCOL SIGNATURE SHEET 
 
 
Name 
Signature 
Date 
For non-commercial research 
Head of Department: 
P.A. Nolte MD PhD 
p/a Spaarne Gasthuis 
Spaarnepoort 1 
2134 TM Hoofddorp 
Tel. 023 – 2246453 
Principal investigator: 
A. van Noort MD PhD 
p/a Spaarne Gasthuis 
Spaarnepoort 1 
2134 TM Hoofddorp 
Tel. 023 – 224 64 59 
Coordinating investigator/project 
leader 
J.I.P. Willems MD 
p/a Medische Kliniek 
Velsen 
 Leeghwaterweg 1b 
1951 NA Velsen Noord 
Tel. 085 – 060 0855 

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TABLE OF CONTENTS 
1. INTRODUCTION AND RATIONALE ................................................................................ 6 
2. 
OBJECTIVES ..................................................................................................................... 8 
3. 
STUDY DESIGN ................................................................................................................ 9 
4. 
STUDY POPULATION ................................................................................................... 11 
4.1 
Population (base) ....................................................................................................... 11 
4.2 
Inclusion criteria ........................................................................................................ 11 
4.3 
Exclusion criteria ....................................................................................................... 12 
4.4 
Sample size calculation .............................................................................................. 13 
5. 
TREATMENT OF SUBJECTS ........................................................................................ 15 
5.1 
Investigational treatments .......................................................................................... 15 
6. 
METHODS ....................................................................................................................... 17 
6.1 
Study parameters/endpoints ....................................................................................... 17 
6.1.1 
Main study parameter/endpoint .......................................................................... 17 
6.1.2 
Secondary study parameters/endpoints .............................................................. 17 
6.1.3 
Other study parameters ....................................................................................... 17 
6.2 
Randomisation, blinding and treatment allocation .................................................... 32 
6.3 
Study procedures ....................................................................................................... 32 
6.4 
Withdrawal of individual subjects ............................................................................. 35 
6.5 
Replacement of individual subjects after withdrawal ................................................ 35 
6.6 
Follow-up of subjects withdrawn from treatment ..................................................... 35 
6.7 
Premature termination of the study ............................................................................ 35 
7. 
SAFETY REPORTING .................................................................................................... 36 
7.1 
Section 10 WMO event ............................................................................................. 36 
7.2 
AEs, SAEs and SUSARs ........................................................................................... 36 
7.2.1 
Adverse events (AEs) ......................................................................................... 36 
7.2.2 
Serious adverse events (SAEs) ........................................................................... 36 
7.3 
Follow-up of adverse events ...................................................................................... 37 
8. 
STATISTICAL ANALYSIS............................................................................................. 38 
8.1 
Descriptive statistics .................................................................................................. 38 
8.2 
Analysis ..................................................................................................................... 38 
9. 
ETHICAL CONSIDERATIONS ...................................................................................... 40 
9.1 
Regulation statement ................................................................................................. 40 
9.2 
Recruitment and consent ............................................................................................ 40 
9.3 
Benefits and risks assessment, group relatedness ...................................................... 40 
9.4 
Compensation for injury ............................................................................................ 41 
9.5 
Incentives (if applicable) ........................................................................................... 41 
9.6 
Handling and storage of data and documents ............................................................ 42 
9.7 
Amendments .............................................................................................................. 42 
9.8 
Annual progress report .............................................................................................. 43 
9.9 
End of study report .................................................................................................... 43 
9.10 Public disclosure and publication policy ................................................................... 43 
10. 
REFERENCES .............................................................................................................. 44 

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LIST OF ABBREVIATIONS AND RELEVANT DEFINITIONS 
 
ABR 
ABR form, General Assessment and Registration form, is the application 
form that is required for submission to the accredited Ethics Committee 
(In Dutch, ABR = Algemene Beoordeling en Registratie) 
AE 
Adverse Event 
AR 
Adverse Reaction 
aTSA 
CA 
Anatomic Total Shoulder Arthroplasty 
Competent Authority 
CCMO 
Centrale Commissie Mensgebonden Onderzoek 
CMS 
Constant Murley Scale 
CV 
Curriculum Vitae 
EU 
EQ-5D 
GCP 
HADS 
European Union 
Euro Qol 
Good Clinical Practice 
Hospital Anxiety and Depression Scale 
IC 
Informed Consent 
METC 
 
 
OSS 
Medical research ethics committee (MREC); in Dutch: medisch ethische 
toetsingscommissie (METC) 
Oxford Shoulder Score 
(S)AE 
(Serious) Adverse Event 
SSV 
Subjected Shoulder Value 
SUSAR 
VAS 
Suspected Unexpected Serious Adverse Reaction 
Visual Analog Scale 
Wbp 
Personal Data Protection Act (in Dutch: Wet Bescherming 
Persoonsgevens) 
WMO 
 
 
WORQ-UP 
WAS 
Medical Research Involving Human Subjects Act (in Dutch: Wet Medisch- 
wetenschappelijk Onderzoek met Mensen) 
WOrk-Related Questionnaire for UPper extremity disorders 
Single-item Work Ability Score

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1. INTRODUCTION AND RATIONALE 
 
Shoulder arthroplasty is a proven procedure for the treatment of severe glenohumeral 
osteoarthritis to relieve pain and restore shoulder function. Anatomic total shoulder 
arthroplasty (aTSA) is the preferred treatment in patients with symptomatic osteoarthritis and 
an intact rotator cuff. The weakest link in total shoulder arthroplasty is the glenoid 
component. Despite the fact that good functional long-term outcomes have been described 
with cemented polyethylene glenoid components as the gold standard, complications related 
to these components are frequent, with (aseptic) loosening as a very common inevitable 
complication in the long term. 1–3 There is an urgent necessity to improve the survival of these 
glenoid components and therefore new designs and fixation methods were developed. The 
uncemented metal back glenoid component was used in an attempt to address this problem 
using a coated back side combined with additional screw fixation. However, multiple studies 
have shown there is a unacceptable high failure rate when compared to polyethylene glenoids, 
which created a shift back to using cemented polyethylene implants. 4–7 In an attempt to 
overcome the high glenoid loosening rates in cemented polyethylene glenoids, several 
companies have developed a hybrid glenoid component, which in most cases consists of a 
polyethylene glenoid with a porous metal central peg which promotes bony ingrowth. In the 
short term, hybrid glenoid components result in excellent improvements in ROM and patient- 
reported outcomes with complication and revision rates comparable to all-polyethylene 
glenoid component. 8,9 The aim of this study is (1) to assess clinical and radiographic 
outcomes after an anatomic SMR stemless prosthesis with either a cemented polyethylene 
pegged glenoid component, or a hybrid Trabecular Titanium (TT) glenoid component; (2) to 
report failure rates and complications; and (3) to identify possible risk factors that may lead to 
failure. Our primary hypothesis is that a hybrid TT glenoid component shows good clinical

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and radiological outcome when compared to a standard cemented pegged all polyethylene 
glenoid. Our secondary hypothesis is that the hybrid TT glenoid improves the longevity of the 
implant by reducing failure and loosening rates. 

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2. OBJECTIVES 
 
Primary Objective: 
 
The primary objective of this study is to evaluate the difference in functional outcome, 
measured by the Constant Murley score in the short, medium and long term after treatment 
with a SMR stemless humeral part of an aTSA combined with a cemented pegged 
polyethylene glenoid component - versus a SMR TT hybrid glenoid component of an aTSA in 
patients with osteoarthritis of the shoulder. 
 
 
Secondary Objective: 
 
Secondary outcome measures to measure the primary objective are the range of motion, OSS, 
SSV, VAS (pain), EQ-5D, HADS, WORQ-UP, WAS, return to work, and difference in 
implant survival in the mid and long term between both groups. Standardised radiologic 
measurements will be used to evaluate any signs of loosening or implant failure. 
Complication and revision rates will be compared. 

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3. STUDY DESIGN 
 
This study is designed as a randomized controlled trial to evaluate the difference in functional 
and radiographic outcome after operative treatment using a stemless total shoulder arthroplasty 
system with either a cemented polyethylene glenoid component (group 1) or a hybrid TT 
component (group 2) and identify possible risk factors that may lead to failure. The inclusion 
and first evaluation will be performed by the orthopaedic surgeon at any of the three 
participating hospitals located in the Netherlands. After informed consent is obtained, the 
patients will be randomly allocated into one of the two groups. Both groups will follow a 
standardized physical therapy program after the intervention. Randomisation will be done 
using the randomisation computer programme Research manager. At baseline, 6 weeks, 3 
months, 1y, 2y, 5y, 7y and 10 y, postoperatively, relevant outcome data are collected through 
clinical evaluation performed by the orthopaedic surgeon or physician assistant. Standard 
radiographs of the shoulder are made at baseline, and during the above-mentioned control 
moments. Both the patient and the researcher present during follow-up will be blinded to the 
type of prostheses implanted and the results of the outcome scores.  

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3.1 Research team 
 
 Principal investigator: A. van Noort, MD PhD, orthopaedic surgeon 
 Coordinating investigator: J.I.P. Willems, MD, orthopaedic surgeon 
 Co-author: A. Akchi Masjediy, medical student. 
 Co-author: M.P.J. van den Bekerom, MD PhD, orthopaedic surgeon 
 Co-author: T.D.W. Alta, MD PhD, orthopaedic surgeon 
 Co-author: G. Janus, MD PhD, orthopaedic surgeon 
 Co-author: O. van der Meijden, MD PhD, orthopaedic surgeon 
 Co-author: I. N. Sierevelt, MSc, clinical epidemiologist 
 Co-author: P.P.F.M. Kuijer, MSc PhD, human movement specialist work 
 
 Ms. M. Schager, Mth, research coordinator 
 Mrs. N. Miedema, nurse practitioner / Mr. P. Spruit, physician assistant 

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4. STUDY POPULATION 
 
4.1 Population (base) 
 
 
The study population consists of a maximum number of 94 treated patients to be recruited 
during an enrolment period of 36 months. Patients will be selected for recruitment into the 
study requiring a primary anatomic shoulder arthroplasty, due to symptomatic painful 
degenerative joint disease (primary osteoarthritis) with sufficient bone stock and an intact 
rotator cuff. A subject is considered to be enrolled in the study, if compliant with 
inclusion/exclusion criteria and agrees to sign the informed consent. Subjects who do not 
meet the inclusion criteria or meet any exclusion criteria are excluded from the study 
participation. These subjects will nevertheless be registered in order to assess potential 
selection bias. It is required to properly report all subjects enrolled in the study on the 
Screening & Enrolment Log. 
 
Only patients withdrawn within the enrolment period because of revoking consent or because 
the investigator deems it necessary due to the clinical condition may be substituted. 
 
4.2 Inclusion criteria 
 
In order to be eligible to participate in this study, a subject must meet all of the following 
criteria: 
 
1. Both genders; 
 
2. Age  18 years old; 
 
3. Life expectancy over 5 years; 
 
4. Patient has symptomatic shoulder osteoarthritis for more than 1 year and is submitted 
to previous conservative non-surgical treatments; 

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5. Patient is requiring primary unilateral or staged bilateral anatomic arthroplasty based 
on physical examination, medical history and X ray examination. (In cases where 
bilateral aTSA’s are indicated, the patient will be included for the second aTSA again 
when the patient meets the inclusion criteria); 
6. Good bone quality evaluated by the investigator on the basis of a risk factors analysis 
and the intraoperative estimation; 
7. A diagnosis in the target shoulder of osteoarthritis; according to the classification of 
Walch, the glenoid should be a type A1, A2 or B1. Retroversion should not exceed 15 
degrees. 
8. Patient is willing and able to complete scheduled follow-up evaluations as described in 
the Informed Consent; 
9. Patient has participated in the Informed Consent process and has signed the Informed 
Consent form previously approved by the Ethics Committee. 
 
4.3 Exclusion criteria 
 
 
1. Patient requiring revision shoulder arthroplasty; 
 
2. Osteoporosis with a history of non-traumatic fractures; 
 
3. Steroid injections within the previous 6 months; 
 
4. Contralateral shoulder replacement within the previous 3 months; 
 
5. Meta-epiphyseal bony defect (including large cysts); 
 
6. Significant proven or suspicious infection of the target shoulder or any serious 
infectious disease 
7. Significant neurological or musculoskeletal disorders that may compromise functional 
recovery; 
8. Known or suspicious hypersensitivity to the metal or other materials of the implant; 

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9. Unwillingness or inability (i.e. alcoholism, infirmity) to comply with rehabilitation 
and to return for follow-up visits and any psychiatric illness that would prevent 
comprehension of the details and nature of the study; 
10. Any systemic disease which may affect outcome. 
 
11. Active or metastatic neoplastic disease 
 
12. Chemotherapy and/or radiotherapy within the last 6 months 
 
13. Previous organ transplant 
 
14. Participation in any clinical research study that may interfere with this study 
15. A current or prior DSM-5 diagnosis of schizophrenia, delusional disorder, schizoaffective 
disorder, psychotic disorder or bipolar disorder. 
16. Current substance use disorder (excluding nicotine/tabacco use disorder) or moderate or 
severe alcohol use disorder. 
17. Imminent suicide risk. 
18. Any other psychiatric condition that renders the individual unsuitable for the study 
according to the study physicians judgment 
 
 
 
 
 
 
 
4.4 Sample size calculation 
 
In this non-inferiority study the Constant Murley score will be used as the primary outcome 
measure. Based on a previous reported minimal clinically important difference (MCID) of 
12.8 ± 2.5 points in anatomic shoulder arthroplasty at a mean 3.5 years follow-up, as 
reported by Simovitch et al.10, the non-inferiority limit of the difference between the two 
designs was set at 10 points. If non-inferiority is proven, secondary testing for superiority 
will be performed.   

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When the sample size in each group is 42 participants, a two group one-sided 0.025 
significance level t-test will have 80% power to reject the null hypothesis that the hybrid 
glenoid and poly-ethylene glenoid are not non-inferior (the difference in means is 10 or 
farther from zero in the same direction) in favour of the alternative hypothesis that the means 
of the two groups are non-inferior, assuming that the expected difference in means is 0 and 
the common standard deviation is 16. 11,12 
When considering a dropout of 10%, this will add up to a total of 94 patients (47 per group). 
There is a slight possibility that patients may require intraoperative conversion to a reverse total 
shoulder arthroplasty if a significant cuff lesion is present. However, this risk is minimal due to a 
thorough preoperative clinical and radiologic assessment. It's important to note that this potential 
risk is already considered in the expected 10% dropout rate. 
 
 

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5. TREATMENT OF SUBJECTS 
 
5.1 Investigational treatments 
 
 
The surgical procedure is conducted by an orthopaedic surgeon qualified by training, with a 
vast experience in primary shoulder arthroplasty, and familiar with the appropriate use of the 
components involved in this clinical evaluation. Before conducting this study, all surgeons 
were trained with the use of the SMR stemless prosthesis including the hybrid glenoid and are 
sufficiently experienced. 
 
Whether the patient is deemed eligible for a stemless anatomic prosthesis is decided by the 
investigator, and is dependent on patient’s pathology and comorbidities. It is decided during 
preoperative planning; however, it can be modified at any time before or during the surgery if 
the investigator notices any clinical condition or complication not related to the 
investigational device. This decision is independent and clearly differentiated from the 
decision to include the patient in the study. If a decision is made to exclude a patient, it will 
be recorded and mentioned separately. 
 
Once a patient is included in the study according to the eligibility criteria, they are submitted 
to primary shoulder arthroplasty as described below. 
 
All the operations in each center will be performed by the same surgeons, and according to 
proper standardized surgical technique. 
 
Type of anaesthesia, postoperative pain management, prophylactic antibiotics, the use and 
dose of tranexamic acid, surgery time and surgical approach will be provided as instructed by 
the investigators, according to the standard practice and will be documented. 

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Surgical technique 
 
 
All procedures are performed through a deltopectoral approach. The choice of subscapularis 
management is made by the investigator and recorded. Following standard exposure, the 
humeral and glenoid implants are placed with use of the implant specific instruments 
provided. After the humeral bone cut, the proximal humeral bone quality will be assessed and 
in case of clear insufficient bone quality, the patient will receive a stemmed implant and will 
be excluded from the study. At the glenoid side, cement is used for all pegs of the all- 
polyethylene glenoid component and for the 2 peripheral pegs of the TT hybrid component . 
Post-operatively, all patients will receive a sling and are required to participate in a 
rehabilitation protocol as prescribed by their surgeon. The physiotherapy treatment protocol is 
adapted to the national guideline. 
 
Intraoperatively, glenoid bone loss will be classified on the basis of location and severity. 
Based on the location, the defects are categorized as central, peripheral (anterior or posterior), 
or combined (central and peripheral) deficiencies. Based on the severity, deficiencies are 
classified as mild if they involved less than one third of the glenoid rim or surface, moderate 
if they involved between one third and two thirds, and severe if they involved more than two 
thirds (Figure 1). 
 
 
 
 
 
 
 
 
Figure I. Glenoid bone loss according to Antuna et al. 13

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6. METHODS 
6.1 Study parameters/endpoints 
 
6.1.1 Main study parameter/endpoint 
 
The main study parameter is the shoulder function as measured by the Constant Murley 
Score. Both the absolute value and the gender and age adjusted value is recorded. An 
analysis for the primary endpoint will be conducted during the 1-year follow-up.  
6.1.2 Secondary study parameters/endpoints 
The remaining follow-up moments shall be analysed in hierarchical order and regarded as 
secondary. Secondary study parameters are the range of motion, Oxford Shoulder Score (OSS), 
Subjected Shoulder Value (SSV), Visual Analog Scale (VAS), Euro Qol 5 Dimensions 
questionnaire (EQ-5D), Hospital Anxiety and Depression Scale (HADS), Work-related 
questionnaire for upper extremity disorders (WORQ-UO), Single-item Work Ability Score 
(WAS) and implant survival. Regarding subjective assessment of function and pain, two questions 
were included. Both questions are a 7-scale assessment of general daily function and pain 
complaints when compared to the preoperative status (very much worse, much worse, a little 
worse, unchanged, a little improved, much improved, very much improved). In order to assess any 
evidence for subsidence or loosening of the implant, thorough radiologic measurements will be 
performed at the periodic follow up, starting immediately postoperatively (baseline) and ending at 
10 years postoperatively. The endpoint for survival is the detection of loosening of the prosthesis 
on radiological imaging. Any complications, whether related or unrelated to the implant, will be 
recorded and assessed.  
6.1.3 Other study parameters/endpoints 
 
Other study parameters that are recorded are demographic data (gender, age, BMI, operated 
side, ASA classification, smoking, workers compensation), type of profession and type of 
sports if applicable. Preoperative use and type of painkillers and/or antidepressants are 
recorded. 

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Additionally, the level of return to work is recorded (not able, partial/with adaptations, fully 
able) and the number of hours at work per week as compared to the preoperative hours and 
premorbid hours. First day of RTW is defined as: time in days from surgery to the first day of 
returning to work, regardless of the number of working hours, adaptations or tasks performed. 
Fully RTW is defined as: time in days from surgery to the first day of the week a patient 
works the number of hours stated in his or her employment contract. For self-employed 
patients, fully RTW is defined as: the first day of the week a patient works the number of 
hours equal to the number of hours he or she worked before surgery. 
 
Outcome measures 
Constant Murley Score (CMS) 
The CMS evaluates four aspects of the shoulder; two subjective: pain and activities of daily 
living and two objective: range of motion and strength.14 The patient self-reported section can 
score up to 35 points and the objective section used by medical professionals can score up to 
65 points, both adding up to a maximum of 100 points (best function). An adjustment to the 
score was described by Katolik et al. to incorporate any differences related to gender and 
age.15 This adjusted CMS is described as a percentage, 100% being the highest possible score. 
Both values will be recorded. 
 
Range of motion 
Active and passive range of motion (ROM) will be recorded in degrees for: 
 
Forward elevation;
 
abduction;
 
external rotation with arm at the side;
 
external rotation in 90° of abduction;
 
internal rotation with arm in neutral abduction;

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 
internal rotation with arm in 90° of abduction.
OSS score 
The Oxford Shoulder Score (OSS) is a 12-item patient-reported outcome specifically 
designed and developed for assessing outcomes of shoulder surgery.16 A total score of 12 
(best) to 60 (worst) can be obtained. It has been designed and developed by the Health 
Services Research unit in association with surgical colleagues at the Nuffield Orthopaedic 
Centre, part of the Nuffield Department of Population Health at the University of Oxford, 
who also created the Oxford Hip and Knee scores, which are used for assessment of all NHS 
hip and knee surgeries (approximately 120,000) since April 2009. The OSS has been tested in 
a surgical context with patients and shown to be reliable, valid and responsive. First published 
in 1996, the OSS has gradually been adopted as an outcome measure, validated in the Dutch 
language and is now widely used in clinical studies. 17 
 
SSV 
The Subjective Shoulder Value was developed by Gerber whom first reported using this value 
in 2000.18 It is a single self-reported value, which is an estimation by the patient of the 
operatively treated shoulder as a percentage of the value for an entirely normal shoulder (that 
is, 100 percent). 
 
VAS 
The Visual Analogue Scale is first developed by Freyd in 1923.19 Since then it has been a 
popular measure for analysing the level of pain the patients experience at that particular 
moment. It is a self-reported patient reported scale from 0-10, 0 resembling no pain and 10 
resembling the worst pain imaginable. 
 
EQ-5D 

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EQ-5D (EuroQol Research Foundation) is a standardised 5-item measure for overall health 
status developed by the EuroQol Group, which was formed by the UK, the Netherlands, 
Finland, Sweden and Norway, as a measure to quantify quality of life with a single numeric 
value.20 
The EQ-5D contains 2 parts: the first part is the EQ-5D-5L descriptive system, consisting of 
questions regarding mobility, self-care, usual activities, pain/discomfort and 
anxiety/depression. The respondent can answer these by ticking a box in one of 5 possible 
answers, being: no problems, slight problems, moderate problems, severe problems, and 
extreme problems. The second part is the EQ Visual Analogue Scale (EQ-VAS) which 
records the respondents self-rated health on a 20 cm, visual analogue scale with endpoints 
labelled ‘the best health you can imagine’ and ‘the worst health you can imagine’, which 
corresponds to a grading of 0-100. 
 
HADS 
The Hospital anxiety and depression scale (HADS) is developed by Zigmond in 1983.21 The 
HADS is a self-assessment mood scale specifically designed for use in non-psychiatric 
hospital departments. The 14-part questionnaire distinguishes between the concepts of 
anxiety and depression, with each composing 7 questions. The overall severity of anxiety and 
depression are rated on a four-point Likert scale (0-3), with a maximum score of 21 for both 
subsections. The subscale scores are 0-7 (no anxiety or depression), 8-10 (possible anxiety or 
depression) and 11-21 (probable anxiety or depression). The Hospital Anxiety and 
Depression Scale (HADS) is included because psychological distress can significantly 
impact pain perception and hinder recovery due to factors like catastrophizing and an 
exaggerated negative focus on symptoms. 33 To improve the efficiency of the estimation of 
the primary endpoint in the presence of severe psychiatric symptoms in participants, the 
following measures will be implemented: 

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1. We will exclude patients with severe psychiatric conditions, including schizophrenia 
spectrum disorders, bipolar disorders, acute suicidality, and severe substance use 
disorders. 
2. We will administer the HADS at both baseline and follow-up assessments, without using 
clinical cut-off scores as exclusion criteria. If group differences in HADS scores are 
observed, these scores will be included as covariates in the statistical analysis. 
This approach allows us to effectively monitor psychological factors and analyze their 
impact on treatment outcomes without unnecessarily limiting the inclusivity of the study 
population. By doing so, we preserve a significant degree of the study's generalizability and 
validity while accounting for important psychological influences on recovery and pain 
perception.  
We will advise participants scoring above the clinical cut-off on the HADS (11 or higher) to 
seek assistance from their general practitioner (GP). With the participant’s consent, we may 
also facilitate communication by providing the GP with relevant information 
 
 
WORQ-UP 
The WOrk-Related Questionnaire for UPper extremity disorders (WORQ-UP) was developed 
in 2018 by Aerts et al. in order to measures to what extent patients with upper extremity 
musculoskeletal disorders experience limitations in their ability to work22. It comprises of 17 
items which reflect work-related activities that can be limited by upper extremity disorders. 
Each item can be answered using a 5-point scale by the difficulty of the respondent to perform 
each item (1 being no difficulty at all, 5 being not possible to perform). If a patient did not 
perform an activity in their job, a score of 0 could be used (not applicable). The highest score 
that can be achieved is 85. 

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Work Ability Score 
The Work Ability Score (WAS) is a single question score, which is the first question from the 
Work Ability Index questionnaire, originally developed in the 1980s at the Finnish Institute of 
Occupational Health (FIOH) as a tool to measure work ability. 23 It is a self-assessment of 
current overall work ability level (range 0–10) in comparison to lifetime best. A score of 0 to 
5 is considered poor, 6 to 7 moderate, 8 to 9 good and 10 is considered excellent. 24,25 

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Radiographic Evaluation 
In the preoperative analysis, radiological assessment includes standard views of the affected 
shoulder: 
 
true antero-posterior (AP) view with arm at side in neutral rotation (Grashey’s view);
 
axillary “truth”view. In this view, the patient’s arm is elevated in the plane of the 
scapula while the beam is oriented in the plane of the scapula. Proper orientation is 
confirmed by visualizing the “eye”of the spinoglenoid notch (figure 2: blue arrow)
 
     
 
 
 
 
 
 
 
 
 
 
Figure 2. Axillary “truth” view 
In order to assess and document the status of the cuff musculature, complementary imaging 
exams using either MRI or CT combined with ultrasound will be used. The choice of 
preferred imaging modality is at the discretion of the treating surgeon. Presence of any tears, 
degree of fatty infiltration or atrophy is carefully documented.

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Analysis and reporting of radiologic studies 
Preoperative: 
There are inadequate objective metrics to evaluate bone quality sufficient for fixation of 
stemless shoulder arthroplasty preoperatively. Final implant selection is determined by 
intraoperative assessment of bone quality by using the thumb test (or index finger test), 
which implies putting gentle pressure of the thumb or index finger on the cut surface of 
the humerus to assess metaphyseal bone quality. If the thumb or index finger is easily 
pressed into the bone, the quality is deemed insufficient for implantation of a stemless 
implant.  
Preoperative DTI has been determined by good ability (AUC of 0.86) to categorize patients as 
appropriate for stemless TSA.26 DTI will be determined preoperatively on true antero-posterior 
(AP) view with arm at side in neutral rotation (Figure 3). 
 
Figure 3. Deltoid tuberosity index 

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A. Glenoid morphology: Using the modified Walch classification. 
 
Glenoid morphology is described according to the classification which was primarily 
proposed by Walch et al.27, which was later modified by Bercik et al. 28 (Figure 4): 
 
Type A: the humeral head is centered, and the resultant strengths are equally distributed 
against the surface of the glenoid. 
 Type A1: There is minor erosion.
 Type A2: Major erosion is present, which is only the case when a line drawn from the 
anterior to posterior rim transects the humeral head

Type B: the humeral head is posteriorly subluxated, and the distributed loads are asymmetric. 
 Type B1 is characterized by a narrowing of the posterior joint space, subchondral 
sclerosis, and osteophytes.
 Type B2 presents a posterior cupula that gives a biconcave aspect of the glenoid.
 Type B3 glenoid is monoconcave and posteriorly worn, with at least 15° of 
retroversion or at least 70% posterior humeral head subluxation, or both.

Type C: has a dysplastic origin, humeral head is well centered or slightly subluxated 
posteriorly. At least 25° of retroversion is present, not caused by erosion. 
 
Type D: A glenoid with any level of glenoid anteversion or with humeral head subluxation of 
less than 40% (i.e., anterior subluxation) 

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Figure 4 Glenoid morphology according to the modified Walch classification27,28 
 
B. Glenohumeral osteoarthritis: OA recorded as being primary or secondary. Secondary 
causes such as post-traumatic, instability, inflammatory arthritis, osteonecrosis, 
neuropathic, cuff tear arthropathy. Additionally, the presence of osteophytes, 
subcortical cysts, osteochondral lesions, intraarticular bodies are recorded. 
C. AC joint and acromial arch: Record presence of ACJ OA and acromial bone spurs 
D. Fractures: Record the presence of acute and/or chronic fractures 
E. Measurements: Record neck-shaft angle, humeral head offset (HHO) between head 
and greater tuberosity, lateral glenohumeral offset (LGHO) between medial border 
coracoid and greater tuberosity. 
F. Prior surgeries: Record the presence of any current or previous orthopedic implant or 
procedure, including nails and screws, plates, wires, cement, or others. 
G. Rotator cuff status, evaluated using CT or MRI as: 
 
intact;
 
attenuated;

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 
minor tear (< 2 cm);
 
large tear (2-5 cm)
 
massive tear (> 5 cm).

Whenever possible, rotator cuff compromise is defined according to the Goutallier 
classification on preoperative images.29 Rupture of the shoulder cuff tendons can induce a 
degeneration of cuff muscles, characterized by an infiltration of these muscles by areas of fat. 
A grading of this so-called fatty degeneration was proposed in five stages: 
 
stage 0 corresponds to a completely normal muscle, without any fatty streak;
 
in stage 1 the muscle contains some fatty streaks;
 
in stage 2 the fatty infiltration is important, but there is still more muscle than fat;
 
in stage 3 there is as much fat as muscle;
 
in stage 4 more fat than muscle is present.
 
H. Others: Record the presence of deformities, bone lesions including tumors (benign or 
otherwise) and bone infarcts, and any other feature observed in the preoperative 
radiographs that may be relevant for preoperative evaluation. 
 
Postoperative: 
 
I. Implant position/size, defined by the following parameters, and compared to pre- 
operative measures whenever applicable. 
 humeral neck-shaft angle, measured using the method described by Beck et al30;
 center of rotation measurements using the best fit circle method31;
 humeral head offset (HHO), measured between head and greater tuberosity;
 lateral glenohumeral offset (LGHO), measured between medial border coracoid and 
greater tuberosity;

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J. Radiolucent lines or osteolysis 
Presence and progression of glenoid and humeral component radiolucent lines or osteolysis. 
Radiolucent lines are graded as follows: 
 None
 1 mm thickness
 2 mm thickness
 >2 mm thickness
The location of radiolucent lines around the humeral head is described as follows(figure 5): 
 Zone 1: Proximal area around the superior part of the trabecular structure of the taper
 Zone 2: Area superior to the curved fins
 Zone 3: Distal area around the mini-stem
 Zone 4: Area inferior to the straight fin
 Zone 5: Proximal area around the inferior part of the trabecular structure of the taper
 
Figure 5 Zones for radiolucent lines evaluation of the humeral component. 
The location of radiolucent lines around the hybrid TT and polyethylene glenoid 
component is described as follows (figure 6a and 6b): 
 Zone 1: Superior part of the base plate
 Zone 1A: Area surrounding the superior peg
 Zone 2: Superior part of the central peg

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 Zone 3: Distal part of the central peg
 Zone 4: Inferior part of the central peg
 Zone 5: Inferior part of the base plate
 Zone 5A: Area surrounding the inferior peg
 Zone 6: Area around the central part of the base plate
 
6a: Evaluation of glenoid radiolucent lines of the hybrid TT glenoid component. 
 
6b: Evaluation of glenoid radiolucent lines of the polyethylene glenoid component. 
 
Additionally, at the glenoid side, RLLs are graded according to the Lazarus classification32 
(Figure 7). 
• Grade 0: No radiolucency 
• Grade 1: Incomplete radiolucency around one or two pegs 

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• Grade 2: Complete radiolucency (≤2 mm wide) around one peg only, with or without 
incomplete radiolucency around one other peg 
• Grade 3: Complete radiolucency (≤2 mm wide) around two or more pegs 
• Grade 4: Complete radiolucency (>2 mm wide) around two or more pegs 
• Grade 5: Gross loosening 
 
 
Figure 7 The Lazarus radiologic classification of glenoid radiolucency.32 
 
The seating grade, also developed by Lazarus et al, will be used in order to classify the 
seating of the glenoid (Figure 8).32 The grades are as follows: 
 
• Grade A: Complete component seating 
• Grade B: <25% incomplete contact, single radiograph 
• Grade C: 25-50% incomplete contact, single radiograph 
• Grade D: <50% incomplete contact, both radiographs 
• Grade E: >50% incomplete contact, single radiograph 
 
 

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Figure 8 Classification of glenoid seating according to Lazarus et al.32 
 
K. Any change of implant position/subsidence: Using the radiographs, implant position 
and any abnormalities such as subsidence/migration, dissociation of components or 
subluxation/dislocation are described. 
L. Glenohumeral subluxation or dislocation, described using the axillary view, is 
classified as follows: 
• None 
• Mild (< 25% translation) 
• Moderate (25 - 50% translation) 
• Severe (> 50% translation) 

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M. Risk of loosening: A component is considered to be radiologically at risk for 
loosening in case of: 
• Circumferential radiolucent line of at least 2 mm around the entire component 
(Lazarus grade 5); 
• Grossly inadequate seating of the component (grade E); 
• progression of radiolucent lines on serial radiographs; 
• or component migration/dislocation. 
 
N. Presence of fractures 
O. Presence of other implants (nails, plates, rings, wires), these may be an indication of 
intraoperative or postoperative complications/adverse events 
P. Presence and location of heterotopic ossification and other calcifications 
 
The total radiation dose used in the context of the study has been calculated by the clinical 
physicist, Mr. Hugo Spruijt. In the standard situation, a total of 1 CT scan and 6 shoulder X-rays 
are taken. As part of the study, 2 additional shoulder X-rays are taken after 2 and 7 years. The 
radiation calculation utilized the international calculator (Radiation risks from medical x-ray 
examinations as a function of the age and sex of the patient, BF Wall et al., HPA-CRCE-028 
(2011), www.hpa.org.uk). The conversion factor the calculator uses for Shoulder AP is 0.064 (for 
Shoulder (axial), it is 0.046). Therefore, in the worst-case scenario, a patient receives 50 
microGy.cm2 for a shoulder series, adjusted with the conversion factor for Shoulder AP, resulting 
in 0.032 mSv or 32 microSievert of ionizing radiation dose. The background radiation due to 
Earth and cosmic radiation in the Netherlands is approximately 6.8 microSievert per day. So, in a 
worst-case scenario, a series of shoulder X-rays adds an extra radiation exposure of about 5 times 
the background radiation in a day. This means that participation in the study results in an 
additional burden of 64 microSievert over 10 years. This amount is negligible and can be 

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compared to the background radiation exposure in 10 days to which every individual is naturally 
exposed. 
 
6.2 Randomisation, blinding and treatment allocation 
To reach similar distribution of the experimental and control prostheses among the 
participating sites, stratified block randomization with variable block sizes will be applied, 
using the randomisation tool from Research Manager (Nova Business Software). 
Additionally, using this technique, the distribution in time is more equal between both groups. 
This software system is designed to facilitate clinical trials. The allocation to each group will 
be concealed and performed by the research assistant. 
 
6.3 Study procedures 
Of the patients with clinical signs of osteoarthritis of the shoulder presenting at the orthopaedic 
outpatient clinic of the participating hospitals, the general history is acquired and standard 
radiographs are made. When the diagnosis primary osteoarthritis is made, and all inclusion 
criteria are met, patient information (written and oral) concerning this trial is provided to the 
patients. The patient will be given a week to consider participation. After one week the patient 
will be contacted by an independent research nurse and asked whether they wish to participate 
or not. After signing the informed consent, patients will be planned for surgery. Allocation of 
the patients to one of the two treatment groups will be done using Research Manager (Nova 
Business Software), and will be performed in the two weeks prior to the procedure. An attempt 
is made for all patients to plan for surgery within three months after inclusion in the study. If 
surgery is delayed for any reason beyond six months, repeat X rays will be made to assess if 
significant changes have occurred, and patients will be reassessed if the inclusion criteria are 
still met. Both groups will follow a standardized physical therapy program after the 
intervention consisting of physiotherapy sessions according to the national guideline including 

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active and passive exercise mobilization techniques to increase power and range-of- motion 
and prevent muscular deficit or imbalance. Aggressive range of motion and subcapularis 
stretching exercises are in any case avoided during the first 6 weeks. 
Follow-up for the study will be at 6 weeks, 3 months, 6 months (only by telephone), 1y, 2y, 
5y, 7y and 10y post-surgery. From 6 weeks postoperatively onwards, the patients are asked to 
fill out the various PROMS, the CMS score is calculated at each follow up moment from 3 
months onwards. Several factors may influence pre – and postoperative PROMS. Use of 
medication will be recorded at every follow-up visit. A medical status will be recorded 
regarding complications and adverse events. Radiographs are made at each follow up 
moment. See table 1 for an overview of events. 

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Table 1. An overview of the events. 
 
 
 
 
 
Assessment for eligibility 
Standard radiographs 
Information regarding study given 
to patient 
Contact with patient 
Written and signed 
informed consent 
Inclusion 
Allocation to group 
Preoperative outpatient clinic visit 
After 1 week 
Treatment (<3 months after inclusion) 
6 weeks postop 
Functional assessment 
3 months postop 
X rays 
PROMS (All) 
6 months post op (Phone) 
PROMS (WORQ-UP, WAS) 
Functional assessment 
1, 2, 5, 7 and 10 years postop 
X rays 
PROMS (All) 
Evaluation including full functional assessment 
PROMS (WORQ-UP, WAS) 
Day after: first postop X ray series 
Physiotherapy for minimum of 6 weeks 
The X-rays at 1, 5, and 10 years are part of standard care.  
 
The X-rays at 2 and 7 years are conducted as part of the study. 

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6.4 Withdrawal of individual subjects 
Subjects can leave the study at any time for any reason if they wish to do so without any 
terminaticonsequences. The investigator can decide to withdraw a subject from the study 
for urgent medical reasons. Per Protocol and Intention To Treat analysis will be applied. 
6.5 Replacement of individual subjects after withdrawal 
Patients who withdraw will not be replaced. Data that are collected up to withdrawal will be 
used for analysis. 
6.6 Follow-up of subjects withdrawn from treatment 
Patients who withdraw will be treated according to the centre standard protocol. 
6.7 Premature termination of the study 
The study will be prematurely terminated if for any reason one of either treatment methods 
can no longer be performed in the participating institutes or if the participating clinicians is 
not able to continue to perform one of either method.   Lima Corporate reserves the right to 
withdraw their funding. This will not affect the continuation of the study itself, which will 
proceed without interruption thanks to stable funding from Spaarne Gasthuis. In this case, the 
specific funding for the PhD candidate would be discontinued. However, this can be 
supplemented by other available resources, such as those from the Spaarne Gasthuis 
Academy, to ensure continued support for the PhD candidate. 

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7. SAFETY REPORTING 
7.1 Section 10 WMO event 
In accordance to section 10, subsection 1, of the WMO, the investigator will inform the 
subjects and the reviewing accredited METC if anything occurs, on the basis of which it 
appears that the disadvantages of participation may be significantly greater than was foreseen 
in the research proposal. The study will be suspended pending further review by the accredited 
METC, except insofar as suspension would jeopardise the subjects’ health. The investigator 
will take care that all subjects are kept informed. 
 
7.2 AEs, SAEs and SUSARs 
7.2.1 Adverse events (AEs) 
Adverse events are defined as any undesirable experience occurring to a subject during 
treatment which may or may not be considered related to the intervention. All adverse 
events reported spontaneously by the subject or observed by the investigator or his staff 
will be recorded. This also includes planned procedures. 
 
7.2.2 Serious adverse events (SAEs) 
A serious adverse event is any untoward medical occurrence or effect that: 
- 
Results in death; 
- 
Is life threatening (at the time of the event); 
- 
Requires hospitalisation or prolongation of existing inpatients’ hospitalisation; 
- 
Results in persistent or significant disability or incapacity; 
- 
Any other important medical event that may not result in death, be life threatening, 
or require hospitalization, may be considered a serious adverse experience when, 
based upon appropriate medical judgement, the event may jeopardize the subject 
or may require an intervention to prevent one of the outcomes listed above. 

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All the SAEs will be reported through the web portal ToetsingOnline to the accredited 
METC that approved the protocol. 
SAEs that result in death or are life threatening should be reported expedited. The 
expedited reporting will occur not later than 7 days after the responsible investigator has 
first knowledge of the adverse reaction. This is for a preliminary report with another 8 days 
for completion of the report. 
 
7.3 Follow-up of adverse events 
All AEs will be followed until they have abated, or until a stable situation has been 
reached. Depending on the event, follow up may require additional tests or medical 
procedures as indicated, and/or referral to the general physician or a medical specialist. 
SAEs need to be reported till end of study within the Netherlands, as defined in the 
protocol. 

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8. STATISTICAL ANALYSIS 
8.1 Descriptive statistics 
All data will be analysed in an encoded fashion in the Spaarne Gasthuis Hoofddorp, the 
Netherlands. We will form a digital database with the obtained data and the two treatment 
groups will be compared. Analysis will be performed by use of SPSS statistical package 
(version 26.0; SPSS, Chicago, Illinois). 
 
8.2 Analysis 
Patient demographics, clinical characteristics and radiographic outcome scores will be 
described according to their distributions. The SMR TT Hybrid Glenoid is the experimental 
procedure. The All Poly 3-pegs Cemented Glenoid is the control procedure.  
 
Continuous variables will be described as means with standard deviations (SD) in case of 
normal distribution, otherwise medians and interquartile ranges (IQR) will be used. 
Categorical variables will be described using frequencies with accompanying proportions. 
As this study has a non-inferiority design, analyses will be performed both Per Protocol (PP) 
and conform the Intention to Treat (ITT) principle. 
Primary non-inferiority analysis of the absolute CMS (defined as change from baseline) will be 
performed using linear regression analysis at the follow up moment of interest. In case of 
confounding (potential confounders: gender, age, BMI, dominance, workers compensation, 
smoking, ASA grade, HADS score), adjustment will be performed by use of multivariate linear 
regression analysis. Non-inferiority analysis of the gender and age adjusted CMS (defined as 
change from baseline) will be performed in the same manner. In case of confounding (potential 
confounders: BMI, dominance, workers compensation, smoking, ASA grade, HADS score), 
adjustment will be performed by use of multivariate linear regression analysis. Crude as well as 
adjusted differences between the treatment groups will be presented with 95%CI. In case the 

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inferiority limit of -10 falls outside the lower bound of the 95%CI of the difference between the 
experimental and control group, non-inferiority is confirmed. 
Additional mixed model analysis will be performed in case of repeated measurements, 
adjusted for confounders where necessary. A one-sided significance level of 0.025 will 
be considered significant. Secondary PROMs will be analysed by use of linear regression 
analysis or mixed model analysis and adjusted for potential confounders where necessary. 
Chi-squared tests will be performed in case of dichotomous variables (e.g. as complications). 
Additionally, revision rates will be calculated at 5 and 10 year follow up by use of Kaplan 
Meier (KM) analysis and compared by use of Log Rank tests. Cox proportional Hazard 
analysis will be performed to calculate Hazard Ratio's with 95%CI, crude as well as adjusted for 
potential confounders (when necessary). Proportional Hazard assumption will be checked 
visually by use of Log minus Log plots. 
For all secondary analyses a p-value of 0.05 is considered statistically significant. 
The idea of initiating the randomization process perioperatively, upon confirming a 
participant's fitness for inclusion, was explored. However, this approach is deemed to lack 
meaningfulness and effectiveness. Being on standby for perioperative randomization would be 
necessary. Moreover, it is probable that the participant's unsuitability for randomization would 
be known before the surgery.

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9. ETHICAL CONSIDERATIONS 
9.1 Regulation statement 
Ethical approval is necessary because of the randomized design of this study. This approval 
is to be obtained by the Medical Ethical committee of the Amsterdam UMC. The study will 
be conducted according to the principles of the Declaration of Helsinki and in accordance 
with the Medical Research Involving Human Subjects Act (WMO). 
 
9.2 Recruitment and consent 
The patients are recruited for the study in all participating hospitals. When a patient is 
diagnosed with symptomatic osteoarthritis and after the decision is made to proceed with 
placement on the waiting list for an anatomic shoulder arthroplasty, the patient will be 
assessed for eligibility for the study using the inclusion and exclusion criteria. If criteria are 
met, the treating physician will briefly inform the patient about the trial The Coordinating 
Investigator will then inform the patient more thoroughly about the trial and explain the 
procedure for consent. The patient will receive both verbal and written information and will 
be given the time to consider participation.   
After one week the patient will be contacted by an independent research nurse and asked 
whether they wish to participate or not. After signing the informed consent, the patients will 
be randomly allocated to one of the two treatment groups using Research Manager (Nova 
Business Software).  
 
9.3 Benefits and risks assessment, group relatedness 
The burden associated with participation is an increased number of subjective scores to fill out, 
an increased number of (non-invasive) measurements of the function of the shoulder. In 
addition to the normal treatment and after-treatment pattern, supplementary mid- and long-
term radiographs will be made to monitor the both implants. The risks associated are not 

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increased, for both methods are widely used and none is so far proven superior. 
9.4 Compensation for injury 
There will be no separate insurance for subjects participating in this study. The risks associated 
are not increased, for both methods are widely used and none is so far proven superior. A 
request for dispensation from the statutory obligation to provide insurance will be made. An 
exemption from the insurance for the subjects participating in the study was requested in 
accordance with the WMO. The investigator has a liability insurance which is in accordance 
with article 7 of the WMO.   
 
9.5 Incentives (if applicable) 
There will be no special incentives, compensation or treatment that subjects will receive 
through participation in the study. The only exception is financial compensation for 
travelling and/or parking costs in case of extra visits to the hospital for the subject (e.g. 
(S)AE’s) 

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ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION 
9.6 Handling and storage of data and documents 
Personal patient files are used and the data obtained in this study will be added to the encoded 
data files in Research Manager (Cloud 9 software, Deventer, Netherlands).  Besides clinical 
data, demographic characteristics are collected. Authorized users can obtain an account and 
insert relevant data for their respective participating center. Independent observers will review 
data that is coded by the principal investigator of the study. Every patient will be given a 
random alphanumeric code. All data will be treated confidentially.  The data will be securely 
stored on the site of the principal investigator, and the research assistant is the only one that 
has access on a day-to-day basis. From each site, encoded data files will be shared with Lima 
Corporate once a specific follow up period is reached for publication purposes.   
Internal monitoring will be provided by the sponsor (Spaarne Gasthuis). All data will be 
handled and stored in accordance with the AVG (Algemene Verordering 
Gegevensbescherming). The encoded data will be stored for a period of 15 years on an 
encrypted server.  
 
9.7 Amendments 
Amendments are changes made to the research after a favourable opinion by the accredited 
METC has been given. All amendments will be submitted to the METC that approved the 
original protocol. 
 
A ‘substantial amendment’ is defined as an amendment to the terms of the METC 
application, or to the protocol or any other supporting documentation, that is likely to 
affect to a significant degree: 
- the safety or physical or mental integrity of the subjects of the trial; 
- the scientific value of the trial; 

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- the conduct or management of the trial or; 
- the quality or safety of any intervention used in the trial. 
All substantial amendments will be submitted to the METC and to the competent authority. 
Non-substantial amendments will not be submitted to the accredited METC and the competent 
authority, but will be recorded and filed by the sponsor.  
 
9.8 Annual progress report 
The investigator will submit a summary of the progress of the trial to the accredited METC 
once a year. Information will be provided on the date of inclusion of the first subject, 
numbers of subjects included and numbers of subjects that have completed the trial, serious 
adverse events/ serious adverse reactions and amendments. 
 
9.9 End of study report 
The investigator will notify the accredited METC of the end of the study within a period of 8 
weeks. The end of the study is defined as the last patient’s last visit. In case the study is 
ended prematurely, the investigator will notify the accredited METC  within 15 days, 
including the reasons for the premature termination. Within one year after the end of the 
study, the investigator/sponsor will submit a final study report with the results of the study, 
including any publications/abstracts of the study, to the accredited METC. Before the study 
reaches its end at the 10 year follow up, intermediate results will be published after 2, 5 and 
10-year follow-up. 
9.10 Public disclosurde and publication policy 
Publication of the research data will be in a journal in the field of research. Whenever 
possible, results of the data will be presented on symposia or annual meetings of related 
instances. 

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10. REFERENCES 
 
1. 
Gonzalez JF, Alami GB, Baque F, Walch G, Boileau P. Complications of 
unconstrained shoulder prostheses. J Shoulder Elb Surg. 2011 Jun;20(4):666–82. 
2. 
Bohsali KI, Bois AJ, Wirth MA. Complications of shoulder arthroplasty. J Bone Jt 
Surg - Am Vol. 2017;99(3):256–69. 
3. 
Kim DM, Aldeghaither M, Alabdullatif F, Shin MJ, Kholinne E, Kim H, et al. 
Loosening and revision rates after total shoulder arthroplasty: A systematic review of 
cemented all-polyethylene glenoid and three modern designs of metal-backed glenoid. 
BMC Musculoskelet Disord. 2020;21(1):1–16. 
4. 
Boileau P, Moineau G, Morin-Salvo N, Avidor C, Godenèche A, Lévigne C, et al. 
Metal-backed glenoid implant with polyethylene insert is not a viable long-term 
therapeutic option. J Shoulder Elb Surg. 2015;24(10):1534–43. 
5. 
Papadonikolakis A, Matsen FA. Metal-backed glenoid components have a higher rate 
of failure and fail by different modes in comparison with all-polyethylene components: 
A systematic review. J Bone Jt Surg - Am Vol. 2014;96(12):1041–7. 
6. 
Page RS, Pai V, Eng K, Bain G, Graves S, Lorimer M. Cementless versus cemented 
glenoid components in conventional total shoulder joint arthroplasty: analysis from the 
Australian Orthopaedic Association National Joint Replacement Registry. J Shoulder 
Elb Surg. 2018;27(10):1859–65. 
7. 
Sharplin PK, Frampton CMA, Hirner M. Cemented vs. uncemented glenoid fixation 
in total shoulder arthroplasty for osteoarthritis: a New Zealand Joint Registry study. J 
Shoulder Elb Surg. 2020;29(10):2097–103. 
8. 
Haleem A, Sedrak P, Gohal C, Athwal GS, Khan M, Alolabi B. Hybrid Glenoid 
Designs in Anatomic Total Shoulder Arthroplasty: A Systematic Review. HSS J. 
2022;18(2):219–28. 
9. 
Malahias MA, Kostretzis L, Gkiatas I, Chronopoulos E, Brilakis E, 
Antonogiannakis E. Total shoulder arthroplasty with hybrid fixation of glenoid 
components consisting of cementless porous metal pegs or cage along with cemented 
backside polyethylene surface: a systematic review. Musculoskelet Surg. 
2020;104(3):229–36. 
10. 
Simovitch R, Flurin PH, Wright T, Zuckerman JD, Roche CP. Quantifying success 
after total shoulder arthroplasty: the minimal clinically important difference. J Shoulder 
Elb Surg. 2018 Feb 1;27(2):298–305. 
11. 
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