The Impact of Humeral Component Version on Outcomes Following Reverse Total Shoulder Arthroplasty: A Prospective Randomized Controlled Trial
Phase: NA
Conditions: Rotator Cuff Tear Arthropathy
Sponsor: Corewell Health East

TITLE:  
The Impact of Humeral Component Version on Outcomes Following 
Reverse Total Shoulder Arthroplasty: A Prospective, Randomized Trial 
 
NCT03111147 
 
Approval date: 02/08/2021 
 
Study Protocol and Statistical Analysis Plan 

Version: Jan 27, 2021 
 
PI: J. Michael Wiater, MD 
Page 1 of 9 
 
The Impact of Humeral Component Version on Outcomes Following 
Reverse Total Shoulder Arthroplasty: A Prospective, Randomized Trial 
PI: J. Michael Wiater, MD 
Co-Investigators: Edward Shields, MD; Denise Koueiter, MS; Lauren Davey, CRC I 
 
Orthopaedic Surgery  
Beaumont Health System 
June 28, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRB NUMBER: 2017-057
IRB APPROVAL DATE: 02/08/2021
IRB NUMBER: 2017-057
IRB APPROVAL DATE: 02/08/2021

Version: Jan 27, 2021 
 
PI: J. Michael Wiater, MD 
Page 2 of 9 
 
TABLE OF CONTENTS 
BACKGROUND AND SIGNIFICANCE ............................................................................................................................3 
OBJECTIVE ...................................................................................................................................................................3 
HYPOTHESIS ................................................................................................................................................................3 
RESEARCH DESIGN AND METHODOLOGY ..................................................................................................................3 
Inclusion Criteria .....................................................................................................................................................4 
Exclusion Criteria ....................................................................................................................................................4 
Enrollment and Consent .........................................................................................................................................4 
Randomization ........................................................................................................................................................4 
Data Collection .......................................................................................................................................................4 
Demographics and Operative .............................................................................................................................5 
Patient Reported Outcomes ...............................................................................................................................5 
Physical Evaluation .............................................................................................................................................5 
Schedule of Events .................................................................................................................................................5 
Statistical Analyses .................................................................................................................................................6 
Sample Size .........................................................................................................................................................6 
Data Analysis ......................................................................................................................................................6 
RISKS AND BENEFITS ...................................................................................................................................................7 
Potential Benefits to Subjects ................................................................................................................................7 
Potential Risks to Subjects ......................................................................................................................................7 
ADVERSE EVENTS ........................................................................................................................................................7 
REFERENCES ...............................................................................................................................................................7 
APPENDIX A ................................................................................................................................................................9 
 
 
 
IRB NUMBER: 2017-057
IRB APPROVAL DATE: 02/08/2021
IRB NUMBER: 2017-057
IRB APPROVAL DATE: 02/08/2021

Version: Jan 27, 2021 
 
PI: J. Michael Wiater, MD 
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BACKGROUND AND SIGNIFICANCE 
Reverse total shoulder arthroplasty (RTSA) relieves pain and improves function in patients with rotator cuff-
deficient arthropathy.2, 5 RTSA has consistently been reported to improve forward elevation and pain, however, 
its effect on internal and external rotation has been less predictable.6 Some studies indicate that humeral 
component version plays a role in improvement of humeral rotation following RTSA, however, the published 
data is contradictory and inconclusive. Several biomechanical studies have suggested that increasing humeral 
component retroversion may improve external rotation, while subsequently decreasing internal rotation. 1,2,4 
Conversely, Henninger et al. reported on a cadaveric study that showed no differences in rotation over a range 
of different humeral component versions.3  A retrospective study by Rhee et al. also suggests that increasing 
humeral component retroversion does not affect measured internal or external rotation. However, they found 
that patients with neutral version may experience better function with daily activities requiring internal rotation 
compared to those with 20 degrees of retroversion.5  Prospective data on clinical outcomes comparing different 
humeral component versions in RTSA is currently lacking.   
The proposed study is a prospective, double-blinded, randomized trial to investigate the impact of humeral 
component version on shoulder range-of-motion and patient-reported functional outcomes following reverse 
total shoulder arthroplasty. 
OBJECTIVE 
➢ The primary objective of this study is to determine whether external rotation and internal rotation two 
years postoperatively is impacted by humeral component version in reverse shoulder arthroplasty 
➢ The secondary objective is to determine whether functional outcomes two years postoperatively are 
impacted by humeral component version in reverse shoulder arthroplasty 
HYPOTHESIS 
➢ Patients that receive RTSA with the humeral component positioned in 30 degrees of retroversion will 
have greater external rotation and worse internal rotation postoperatively than those that have 0 
degrees of version. 
➢ Patients that receive RTSA with the humeral component positioned in 0 degrees of version will have 
higher functional outcomes scores, due to improved internal rotation, than those that have 30 degrees 
of retroversion.  
RESEARCH DESIGN AND METHODOLOGY 
We will perform a prospective, randomized trial with a total of 85 patients. Patients undergoing primary RTSA by 
Dr. J. Michael Wiater at Beaumont Hospital Royal Oak will be screened for eligibility. After the patient has been 
consented they will be randomized to one of the following two groups: 
1. RTSA with humeral component positioned in 0 degrees of version  
2. RTSA with humeral component position in 30 degrees of retroversion  
The patient will be blinded to the study group. 
IRB NUMBER: 2017-057
IRB APPROVAL DATE: 02/08/2021
IRB NUMBER: 2017-057
IRB APPROVAL DATE: 02/08/2021

Version: Jan 27, 2021 
 
PI: J. Michael Wiater, MD 
Page 4 of 9 
 
INCLUSION CRITERIA 
• 
Patients undergoing primary reverse total shoulder arthroplasty (with Biomet component, glenosphere 
size 36) 
• 
Diagnosis of cuff tear arthropathy, massive cuff tear, or primary osteoarthritis with cuff tear 
• 
negative external rotation lag sign, ability to externally rotate beyond neutral 
• 
Age 18 years or older 
EXCLUSION CRITERIA 
• 
Revision arthroplasty 
• 
Prior open shoulder surgery 
• 
Concomitant latissimus dorsi transfer 
• 
Diagnosis of rheumatoid arthritis, infection, acute trauma or instability 
• 
Patients not undergoing a standard-of-care physical therapy protocol 
• 
Pregnant, patient-reported 
• 
Minors (under 18 years of age) 
• 
Cognitively impaired 
ENROLLMENT AND CONSENT 
Patients scheduled to undergo reverse total shoulder arthroplasty with Dr. Wiater will be screened 
preoperatively for eligibility. Patients will be identified in the clinic and by operative schedules. Patients that 
meet all criteria will be contacted by personnel on the delegation of authority as a consent provider before their 
procedure. If the patient is interested, the research coordinator will offer to email or mail a copy of the consent 
for the patient to review beforehand. During the time of consent, the patient will confirm they have read and 
understand the consent. Patients can discuss any questions they may have with the consent provider at this 
time. Patients will be allowed to drop out of the study at any time before or after their procedure. 
RANDOMIZATION 
The 85 patients enrolled in the study will be randomized in a 1:1 ratio to have their procedure performed either 
with a humeral component positioned in 0 degrees of version or 30 
 degrees of retroversion. Randomization assignments will be contained in sequentially numbered, opaque, 
sealed envelopes, which will be prepared by a statistician in the research institute. After the patient is 
consented, they will be assigned to a group following the treatment listed in the envelope. Key personnel not 
collecting data will perform randomization and inform the surgeon of the group in order to keep data collection 
blinded. The patient will also remain blinded to their assignment. Logs will be maintained by the randomizing 
personnel.  
DATA COLLECTION 
Baseline data will be collected before the patient’s procedure, after consent has been signed. Patients will be 
followed at standard-of-care follow-up appointments in the clinic at 3 months, 6 months, one year, and two 
years postoperatively. To help prevent dropouts, follow-up requirements will be discussed with the patient 
before consent and all patients will be called as each time point approaches to schedule follow-up 
appointments. At each appointment the patient will complete patient-reported outcomes questionnaires and 
will undergo a physical exam with a clinical research coordinator blinded to the patient’s study group. Standard-
of-care x-ray images will also be assessed. 
IRB NUMBER: 2017-057
IRB APPROVAL DATE: 02/08/2021
IRB NUMBER: 2017-057
IRB APPROVAL DATE: 02/08/2021

Version: Jan 27, 2021 
 
PI: J. Michael Wiater, MD 
Page 5 of 9 
 
DEMOGRAPHICS AND OPERATIVE 
• 
Name 
• 
Age 
• 
Gender 
• 
BMI 
• 
Comorbidities, as recorded by anesthesiology  
• 
Date of surgery 
• 
Laterality  
• 
Dominant hand 
PATIENT REPORTED OUTCOMES 
• 
American Shoulder and Elbow Surgeons’ Score (ASES) 
• 
Western Ontario Osteoarthritis of the Shoulder Score (WOOS) 
• 
Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) 
• 
Visual analog scale (VAS) pain 
PHYSICAL EVALUATION 
• 
Range-of-motion, measured with a goniometer (forward elevation, abduction, external rotation, internal 
rotation) (See Appendix A) 
• 
Strength, measured with a dynamometer (in forward elevation, abduction, external rotation, internal 
rotation) (See Appendix A) 
• 
External rotation lag sign test 
• 
Drop arm test 
• 
Lift off test 
• 
Belly press test 
SCHEDULE OF EVENTS 
Study Procedure 
Preoperative 
Surgery 
3 months 
6 months 
1 year 
2 years 
Visit Window 
8 wks to surgery 
N/A 
± 4 weeks 
± 6 weeks 
± 2 months 
± 4 months 
Review inclusion and 
exclusion criteria 
X 
 
 
 
 
 
Informed consent review 
and signature 
X 
 
 
 
 
 
Study group 
determination 
(randomization) 
 X* 
 
 
 
 
 
Intervention  
 
X 
 
 
 
 
Patient-reported 
outcomes questionnaires 
(ASES, WOOS, PROMIS, 
VAS) 
 X* 
 
X 
X 
X 
X 
Physical exam (range-of-
motion and strength) 
X* 
 
X 
X 
X 
X 
Standard-of-care x-rays 
X* 
 
X 
X 
X 
X 
IRB NUMBER: 2017-057
IRB APPROVAL DATE: 02/08/2021
IRB NUMBER: 2017-057
IRB APPROVAL DATE: 02/08/2021

Version: Jan 27, 2021 
 
PI: J. Michael Wiater, MD 
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Assess for adverse events 
X* 
X 
X 
X 
X 
X 
*Consent will happen before any study procedures or assessment are done and randomization will occur at that 
time 
STATISTICAL ANALYSES 
SAMPLE SIZE 
We performed a sample size analysis to determine how many patients are needed to be able to detect the 
minimal clinically important difference in shoulder external/internal rotation, which is between 14° and 22°.7 We 
used 80% power and a significance level of 0.05, and based on a review of the literature, we expect a standard 
deviation between 8° and 18°.5 Table I illustrates for each effect size, the minimum detectable difference with a 
standard deviation of 8° and of 18°. Using a sample size of 35 per group (effect size = 0.68), we would be able to 
detect between 5.4° and 12.2° difference, which will be sufficient to detect a clinically important difference.    
Table I. Varying effect size and sample size for 80% power and α=0.05, and the minimum detectable differences 
with a standard deviation of both 8 and 18.  
Effect Size 
Total N 
n Per 
Group 
Standard 
Deviation 
Minimum 
Detectable 
Difference 
Standard 
Deviation 
Minimum 
Detectable 
Difference 
0.55 
106 
53 
18 
9.9 
8 
4.4 
0.60 
89 
45 
18 
10.8 
8 
4.8 
0.64 
80 
40 
18 
11.52 
8 
5.12 
0.65 
76 
38 
18 
11.7 
8 
5.2 
0.68 
70 
35 
18 
12.2 
8 
5.4 
0.7 
66 
33 
18 
12.6 
8 
5.6 
0.75 
58 
29 
18 
13.5 
8 
6 
0.8 
51 
26 
18 
14.4 
8 
6.4 
 
DATA ANALYSIS 
The range-of-motion, strength measures, patient-reported outcomes scores, and patient demographic factors 
will be compared between the two treatment groups. A table of descriptive summaries by treatment group will 
be prepared (means and standard deviations if normally distributed, median and range if not normally 
distributed, counts and percentages for categorical variables). Confidence intervals for the means/medians for 
each of the two groups will also be computed. The change from baseline as well as the absolute postoperative 
outcomes measurements will be used for comparison. Before comparing continuous variables, data sets will be 
assessed for normality using a Shapiro-Wilk Test. For normal data, an independent student’s t-test will be used 
to compare means. A Mann-Whitney Rank Sum Test will be used for data that is ordinal or not normally 
distributed. The two treatment groups will be compared on categorical variables using the Fisher’s Exact test. 
Missing data will not be imputed, but the number of data points available at each time point postoperatively will 
be clearly reported in publications. For all tests, a p-value < 0.05 will be considered statistically significant. A 
Bonferroni correction will be used to account for repeated measures and control for a Type I error. Graduate-
trained engineers will analyze data with SPSS statistical software (SPSS Version 22.0, IBM, Inc). 
IRB NUMBER: 2017-057
IRB APPROVAL DATE: 02/08/2021
IRB NUMBER: 2017-057
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Version: Jan 27, 2021 
 
PI: J. Michael Wiater, MD 
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RISKS AND BENEFITS 
POTENTIAL BENEFITS TO SUBJECTS 
Patients enrolled in the study may have better range-of-motion or function if one technique proves superior. 
However, there may be no direct benefit from inclusion in this study.  It is hoped that the results of this study 
will help doctors learn which treatment is most effective for maximizing outcomes after reverse total shoulder 
arthroplasty. 
POTENTIAL RISKS TO SUBJECTS 
The risks of participating in this study include the same risks normally associated with reverse total shoulder 
arthroplasty surgery whether the patient is in the study or not. Both techniques (30 degrees of humeral 
component retroversion versus 0 degrees of version) are standard-of-care, based on surgeon preference. There 
is a chance that patients enrolled in the study may have worse range-of-motion or function if one technique 
proves inferior. However, this has yet to be proven.  
With any procedure, unusual, unexpected or previously unreported side effects may occur. Risks will be 
assessed throughout the course of the study. 
There is also the rare risk of breach of confidentiality. Every effort will be made to maintain patient privacy, 
however this cannot be guaranteed. 
ADVERSE EVENTS 
The participants will be monitored for risks and AEs related to surgery or the device throughout the course of 
the study. The PI will be responsible for tracking the occurrence of AEs while the patient is enrolled in the study. 
The PI will determine the relationship between the study-based surgical technique (i.e. humeral version) and the 
occurrence of an AE/SAE. 
REFERENCES 
1. Berhouet J, Garaud P, Favard L. Influence of glenoid component design and humeral component 
retroversion on internal and external rotation in reverse shoulder arthroplasty: A cadaver study. Orthop. 
Traumatol. Surg. Res. 2013;99(8):887–894. doi:10.1016/j.otsr.2013.08.008 
2. Gulotta L V, Choi D, Marinello P, Knutson Z, Lipman J, Wright T, et al. Humeral component retroversion 
in reverse total shoulder arthroplasty: a biomechanical study. J. Shoulder Elbow Surg. 2012;21(9):1121–
7. doi:10.1016/j.jse.2011.07.027 
3. Henninger HB, Barg A, Anderson AE, Bachus KN, Tashjian RZ, Burks RT, et al. Effect of deltoid tension and 
humeral version in reverse total shoulder arthroplasty: a biomechanical study. J. Shoulder Elbow Surg. 
2012;21(4):483–90. doi:10.1016/j.jse.2011.01.040 
4. Jeon B-K, Panchal KA, Ji J-H, Xin Y-Z, Park S-R, Kim J-H, et al. Combined effect of change in humeral neck-
shaft angle and retroversion on shoulder range of motion in reverse total shoulder arthroplasty - A 
simulation study. Clin. Biomech. (Bristol, Avon). 2016;31:12–9. doi:10.1016/j.clinbiomech.2015.06.022 
5. Rhee YG, Cho NS, Moon SC, Boileau P, Walch G, Boileau P, et al. Effects of humeral component 
retroversion on functional outcomes in reverse total shoulder arthroplasty for cuff tear arthropathy. J. 
Shoulder Elb. Surg. 2015;24(10):1574–1581. doi:10.1016/j.jse.2015.03.026 
IRB NUMBER: 2017-057
IRB APPROVAL DATE: 02/08/2021
IRB NUMBER: 2017-057
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Version: Jan 27, 2021 
 
PI: J. Michael Wiater, MD 
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6. Wall B, Nové-Josserand L, O’Connor DP, Edwards TB, Walch G. Reverse total shoulder arthroplasty: a 
review of results according to etiology. J. Bone Joint Surg. Am. 2007;89(7):1476–85. 
doi:10.2106/JBJS.F.00666 
7. Muir SW, Corea CL, Beaupre L. Evaluating change in clinical status: reliability and measures of agreement 
for the assessment of glenohumeral range of motion. North American Journal of Sports Physical 
Therapy. 2010; 5(3) 98-110. 
 
 
 
IRB NUMBER: 2017-057
IRB APPROVAL DATE: 02/08/2021
IRB NUMBER: 2017-057
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Version: Jan 27, 2021 
 
PI: J. Michael Wiater, MD 
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APPENDIX A  
 
 
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IRB NUMBER: 2017-057
IRB APPROVAL DATE: 02/08/2021