Outcome Following Reverse Shoulder Arthroplasty for Acute Proximal Humerus Fractures in Patients 60 Years of Age and Older With Different Inclination Implants Versus Non-surgical Treatment- Trial Protocol: a Prospective RCT, Single Blinded
Phase: NA
Conditions: Proximal Humeral Fracture, Humeral Head Fracture
Sponsor: University of Southern Denmark

Outcome following reverse shoulder arthroplasty for acute 
proximal humerus fractures in patients 60 years of age and 
older with different humerus inclination implants versus 
non-surgical treatment- trial protocol: a prospective 
randomised controlled trial, single blinded. 
Klaus Hanisch1 
 
 
Abstract 
Introduction:  
The optimal treatment of proximal humerus fracture (PHF) Neer type III and IV AO B1.1,1.2 and 
C1.1,3.1 is controversial. National guidelines for Denmark have been published in 2015 and 
updated 2019. They recommend conservative treatment to all kinds of PHF for patients aged 
above 60 years. Exceptions are fracture-dislocations, headsplits or surgical conditions, where 
intervention is mandatory like open fractures and impaired nerve- and circulation. 
Recently reverse shoulder arthroplasthy (RSA) has gained expanding popularity in treating PHF1. 
Compared with osteosynthesis (ORIF) or hemiarthroplathy (HA) outcomes were superior2,3. The 
importence of tuberosity healing for good functional outcomes has lead to development of 
different implants and fixation techniques. The original RSA design by Grammont with 155 degree 
inclination of the humeral stem was made for cuffarthropathy. This design moves the center of 
rotation in a medial direction, and increase the tension on the tuberosities.  
In contrast “anatomical” designed humeral implants with 135 degree enables more anatomical 
refixation of the tuberosities with less tension and might reduce the risk of resorption or 
displacement of the fragments. To implant a 155 degree RSA the surgeon has to remove parts of 
the rotator cuff, to enable the sliding rotation. On the other hand with a 135 degree inclination 
humeral component, a cuff sparing technique is possible.  
 
The aim of this study is to compare outcomes of two different designed RSA stems versus 
conservative treatment of PHF Neer type III or IV / AO B&C. 
                                                          
1 The Orthopedic Department, University Hospital of South West Denmark, Esbjerg, Denmark 

 
Methods:  
The study design is a prospective randomized controlled, single blinded for the patients, single unit 
trial to compare outcomes of displaced proximal humerus fractures treated either non-operative 
versus reverse shoulder arthroplasty. Subgroups for RSA differs in inclination of the humeral stem 
(HI) 135 versus 155 degree. The elderly, 60 to 90 years of age includes in this trial. Patients, who 
meet the inclusion parameters, will be block randomized to one of the two groups.  Sixty-four 
patients will be treated non-surgically (Group A). Thirty-two patients in each group will be treated 
surgically (Group B & C). All follow a standardized rehabilitation program in the public health-
system.  
The primary outcome is Western Ontario Osteoarthritis of the Shoulder Index (WOOS)4, Minimal 
Clinical Important Difference (MCID) assumed to be 12.3 points5 . Secondary outcomes include 
Constant Murley (CS)6 and Subjective shoulder Volume (SSV)7. Radiographs will be valuated 
independently by to researchers to state union/ non-union/ pseuoarthrosis in the non-surgical 
group and Tuberosity Healing (TH) as healed, mal-union more than 5 mm or resorbed in the 
surgical group.  
Complication and revisions will be noticed within two years of follow-up.  
Serious Adverse Events (SAE) 
Luxation 
Infections 
Fractures 
Non-union 
Caput-necrosis 
are the main reasons for revisions/ secondary interventions. 
Adverse Events (AE) 
Nerve-injuries 
Vascular-injuries 
Persistent pain 
Participants form non-surgical group, who be treated operatively at a delayed time point (cross-
overs) will be noted.  
 
 

 
 
The follow-up timetable: 
Assessment 
Time 0 
2 weeks 
3 mths. 
1 year 
2 years 
x-ray 
X 
X (non-surg) 
X 
X 
X 
CT 
X 
 
 
 
 
Ex-/inclusion 
X 
 
 
 
 
Consent 
X 
 
 
 
 
WOOS 
 
 
X 
X 
X 
Constant 
 
 
X 
X 
X 
SSV 
 
 
X 
X 
X 
Elevation subj  
 
X 
X 
X 
 
 
  
 
Ethics and dissemination: 
This trial has been approved by the Regional Sientific Committe for Region southern Denmark 
01.september 2021 (21/38868). Trial registration number  https://www.isrctn.com/ISRCTN85422168 
The results will be disseminated in an orthopedic publication. 
 
 
Sample size and Randomization 
participants in each group has to be included by block randomization  
CONSORT Flow Diagram 
 
 
 
 
Assessed for eligibility (n=  ) 
Excluded  (n=   ) 
   Not meeting inclusion criteria (n=  ) 
   Declined to participate (n=  ) 
Randomized (n=128) 
Enrollment 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analysis and statistics 
The first hypothesis of this trial is that RSA provides better results than non-surgical treatment. 
The second hypothesis is that RSA with less degree humeral inclination achieve the better 
outcome than RSA with high degree. The trial setting has been drafted in accordance with the 
Consolidated Standards of Reporting Trials (CONSORT) and Standard Protocol Items: 
Recommendations for Interventional Trials (SPIRIT) statements.  
Out of our previous results for fracture cases treated with RSA we determined the standard deviation as 
22.9 and calculated with the estimated MCID of 12.3 a sample size of 58 in each group non-operative 
versus operative. (Confidence Interval (2 sided) 95%, Power 80%). 
Analysed  (n=  ) 
 Excluded from analysis (give 
reasons) (n=  ) 
Lost to follow-up (give reasons) (n=  ) 
Allocated to 155 (n= 32 ) 
 operated (n=  ) 
 complications-revisions (n=  ) 
Lost to follow-up (give 
reasons) (n=  ) 
 
Allocated to 135 (n= 32 ) 
 operated (n=  ) 
 complications-revisions (n=  
Analysed  (n=  ) 
 Excluded from analysis (give 
reasons) (n=  ) 
Allocated to non-surgical (n=64) 
 stay conservative (n=  ) 
 converted to surgery  (give 
Lost to follow-up (give reasons) 
(n=  ) 
Analysed  (n=  ) 
 Excluded from analysis (give 
reasons) (n=  ) 

After ramdomisation 16 cases per block, eight blocks are needed to include 128 patients. Some drop out or 
cross-over is expected and thereby taken into account.   
 
Patient information 
Patient will be asked verbally and in written form after been diagnosed PHF Neer type III / IV AO B, C, in the 
orthopedic outpatient clinic. They get offered treatment either non-surgical or surgical.  
Patient selection 
The eligible study population will comprise all consecutive patients aged 60 years or older with a 
proximal humerus fracture Neer Type 3&4 operated within 14 days of the trauma or treated non-
operative. The lower age limit was chosen according danish national guidelines, recommending 
conservative treatment to all kinds PHF in this age-group, excepitions made for headsplits and 
dislocations.  
 
Exclusion criteria: 
-Patients younger than 60 or older than 90 years of age  
-Neer Type 1&2, Head splits, gleno-humeral dislocations 
-pathological fractures 
-refuse to participate in the study 
-non-compliant, drug/alcohol abuse or institutionalized  
 (Low-cooperative) 
-surgical contraindications or surgical condition, where operative treatment is mandatory 
-Does not understand written and spoken guidance in local languages. 
 
Randomization 
 
Patients will be randomized using lottery in block allocation fashion in sealed non-transparent 
envelopes. Four blocks of 16 lots will be used for the three groups (A,A,B,C)  
 
Non-operative treatment 
 
Patients in the non-operative group will be immobilized in a sling for 2 weeks before starting self-
exercises and instructed physiotherapy. Postoperative treatment differs with respect to timeline 
between the surgical treatment group and the non-operative group due to the different degree of 
stability for a reversed prosthesis and a non-operatively treated displaced fractures. The elements 

of physiotherapy will, however, be the same. Subgroups for varus-inclinated fractures with more 
than 20 degrees versus valgus impacted fracture types with more than 30 degrees of angulation 
will be made.   
 
 
 
Surgical treatment 
 
Operative treatment will be performed as a daytime procedure by trained and experienced upper 
extremity surgeons. The standardised approach will be the delto-pectoral. The Delta Xtent (Depuy 
Johnson&Johnson) humeral stem, modular HA-coated, 155 degree will be the implant in the 
second group. Emphasis will be made at the humeral side on cementing and auto-transplanting 
technique (black-tan)8 and refixation of the tuberosities in “Nice-knot” fashion9. Parts of the 
supraspinatus-tendon will be removed. On the glenoid-side glenosphaere-size 42 will be the 
implant of choise to gain stability.  
Univers Revers (Arthrex) will be the implanted for group 3. On the humeral side an uncemented 
modular stem in 135 degree inclination will be used. In unstable humeral conditions cementing is 
optional. Fixation of the tuberosities and grafting will be made in similar fashion. The MGS-glenoid 
will be used with 4 mm lateral offset at the glenoshaere. Tendon-resection will not be necessary, 
restoring of the gothic arc the goal.         
 
Rehabilitation 
 
In order to achieve as good functional outcomes as possible, the rehabilitation protocols will be 
standardized in all treatment groups and the patients will be given a written protocol. Patients in 
all groups will be guided by in-ward physiotherapists and will be given written physiotherapy 
guidelines for both instructed physiotherapy and self-exercises. After discharge from the hospital, 
patients will be referred to physiotherapy for further guidance. Patients in the operative group will 
start exercises from the first postoperative day. 
  
 
 
 
Risks of side effects, disadvantages, injuries 
The orthopedic department of university south west Denmark, Esbjerg is specialized in shoulder 
replacement and cover a population of about 1 million citizens. Three experienced surgeons will perform 
the procedures at a public hospital. The rehabilitation is standardized and similar in each group.  
All participant are covered by the patient-insurance of region southern Denmark. 

 
Sponsors 
No sponsors. All treatment-costs are covert by the Danish public health-system without any charge. The 
authors declare no financially interests of any kind of treatment. 
 
Trial schedule 
 
The recruiting and allocation started in september 2021 and is expected to last three years. 
Further two years of follow-up are needed; publishing will be earliest late in 2026.  
 
Results 
 
 
Non-operative 
Delta Xtent 155 
Univers reverse 135 
N total 
30 
10 
12 
N female/  median age 
28/72 
8/70 
10/73 
N male/ median age 
2/75 
2/83 
2/70 
WOOS 3 month 
55 
58 
68 
WOOS 12 m 
58 
77,7 
80 
WOOS 24 m 
 
 
 
Elevation 3 month 
90 
86 
87 
Elevation 12 m 
81 
108 
120 
Elevation 24 m 
 
 
 
Constant-Murley 3 
month 
34 
36 
37 
CMS 12 m 
38 
45 
49 
CMS 24 
 
 
 
SSV 3 month 
41 
41 
56 
SSV 12 m 
47 
64,8 
82 
SSV 24 m 
 
 
 
satisfied 
11 
6 
11 
non-satisfied 
10 
3 
1 
cross-over 
1 
 
 
Tuberculi healed anat. 5 
10 
7 
Tuberculi healed displ 
10 
 
 
Tuberculi not healed 
4 
 
 
Complications/ % 
 
 
1 (infection) 
Death/ % 
 
 
 
 
 

 
Discussion 
PHF is common and non-operative treatment is indicated in most factures Neer type I and II. In 
type III or IV, in headsplints or fractures with luxations surgical treatment can be necessary. In 
Denmark national treatment guidelines were published in 2015 and updated in 2019. They stated 
conservative treatment for all patients with PHF age over 60, unless headsplint or dislocations 
occur.  One updatet review by Handoll H 202210 base on one RCT´s reported nonoperative versus 
RSA of the study by Lopiz (19). The review by Lin Ch11 draws a slightly different conclusion: RTSA 
for an acute PHF is indicated  in patient who are >65 years of age with3- and4-part fracture-
dislocation, head-split fractures, and severely displaced fractures, and is an option in patients who 
are not able to tolerate nonoperative treatment of severely displaced 3- and4-part fractures. 
Support for non-operative treatment comes by Rasmussen S. 199212, they stated, that displaced 
PHF can be treated satisfactory. A systematic Review of non-operative treatment of PHF by 
Iyengar J 201113 found high rates of radiographic healing, good functional outcomes and modest 
complicationrates. Robertson T. 2017 14retrospective  reviewed 19 nonoperative, who declined 
surgery versus 20 RSA and found minimal benefit of RSA. The PROPHER RCT Rangan A 201515 
compared surgical vs non-surgical treatment of PHF and found no significant difference. Of 109 
operations performed by 66 surgeons in 30 centers, 90 were ORIF, 4 nails, 10 hemiarthroplasty, 5 
others. No fracture classification was used. Recently Soler-Peiro M. 202016 reviewed systematically 
conservative treatment of Neer 3- and 4 part PHF. They found consolidation in most fractures with 
negligible rate of mal-unions, good functional results with few complications.  
The use of a standardized treatment algorithm by Katthagen JC 201717 looked into failure and 
revision rates. Other studies compared different surgical approaches. Fraser AN, Fjalestad T 202018 
conducted  a multicenter randomised controlled trial (DelPhi) and found at 2 –years follow-up 
advantage of RSA over ORIF in displaced OTA/AO type B and C. RSA versus HA for PHF by Ball CM19 
2017 is based on the shoulderarthroplasty registry of New Zealand and included 218 RSA and 427 
HA from 1999 to 2014. The RSA group was older and 90% female, the revision rate was lower for 
RSA and the functional outcome better at 5 years. Significant difference were not demonstrated.  
Lopiz Y.20 (2019) analyzed in a prospective RCT 30 non-operative vs 29 RSA age 80 and older. They 
found no significant difference between both groups. Retrospective Chivot M.21 (2019) found in an 
age-group older than 70 years, RSA vs non-operative for 3 and 4-part PHF significant better results 
for RSA and Constant-score, the complications rate was higher for RSA. They suggested RSA for 
higher demand patients. A registry analysis of 5946 patient from Australia by Critchley O 202022 
RSA vs HA focused on revision rates between 2004 and 2014. 51% RSA vs 49% HA had lower 
revision rates within 9 years 7.0 vs 11.7%, Younger males (55-64) had more luxations, cemented 
stems had lower revision rate. The importance of greater tuberosity healing for clinical outcomes 
is shown by Ohl X.2018 (9). They compared outcomes after tuberosity excision, failed fixation or 
anatomical healing and found that anatomical tuberosity healing in RSA for PHF improves 

objective and subjective outcomes, excision was associated with worst outcome.  Tuberosity 
healing after reverse shoulder arthroplasty for acute proximal humerus fractures: the ‘‘black and 
tan’’ technique Levy J, (2015)23 showed significant improvement in TH. This technique together 
with standard suture repair and implants, who support tuberosity healing results in a high healing 
rates with restoration of external rotation after reverse shoulder arthroplasty for fracture. 
Brorson St and Rasmussen J24 2013 did one systematic review for RSA in acute PHF. They found 
the functional outcome not clearly superior to HA, with higher complication rates for RSA and risk 
for scapular notching. A Nordic registry-based study of 6756 replacements by Brorson St and 
Rasmussen (2017)25 looked into revision rates after shoulder replacement for acute PHF. Between 
2003 and 2013 90% were HA, 8.4 % RSA. The 5 year survival rate was 0.96 for both, the relative 
risk for revision 1.4 RSA/HA, higher in the age group less than 75 years. Reasons for revision were 
mainly infections, instability, periprosthetic fractures or loosening. Jonsson E (2021)26 randomizied 
99 patients to RSA versus HA and conclude that RSA provides better function by CMS , patients are 
more satisfied , aged > 80 years benefit less from RSA.   
The influence of humeral head inclination in RSA was reviewed by Romeo A27 (2015), They found 
lower rates for scapular notching and dislocation in the 135 degree group. External rotation were 
significant better in this anatomic group, too. No subgroups for different indications were made. 
Walch G28 2015 found dramatic improvement in adduction, extension and external rotation with 
varus inclination prostheses. Denard P29 2015 found similar results. Uncemented RSA as initial 
treatment for PHF by Wiater B30 2019 showed 97% stable humeral stem fixation and 70% healing 
of the tuberosities. Good functional results were achieved. Krishnan S31 (2021) reported on 60 
uncemented RSA with excellent ROM and functions-scores, 91% TH, 6.7% revision rate. The study 
on 135 degree RSA for PHF focused on TH by Gerhardt Ch32 (2020) with four years FU showed 
adjusted CS 61, TH 82%, SSV 79 %, revision rate 5%, scapular nothching 3%. Half of the implants 
were uncemented. They suspected that RSA with humeral inclination of 135 degree allows 
refixation of the tuberosities in a more anatomic position and therefor might result in decreased 
stress on the tuberosity repair. A biomechanical study compared stability of the tuberosity fixation 
in reverse fracture arthroplasty with different humerus inclination angles and found higher 
stability for 135 degree33. Cuff DJ (2013)34 compared HA vs RSA for PHF with 135 degree fracture-
stem with similar good TH with DJO Reverse implant. Uncemented 135 HI stem SMR by Lima have 
been used be Sebastia-Forcada (2014)35. They found better pain and function and lower revision 
rate in RSA. Revision from HA to RSA does not appear to improve outcomes. Youn S-M. (2016)36 
used the same uncemented implant. They found no early loosening or failure. In one systematic 
review of tuberosity healing O`Sullivan J. (2020)37 found RSA for fractures abduction highest in 155 
degree group, tuberosity healing 83 %. With tuberosity healing 18 degree higher forward flexion 
and 16 degree greater external rotation. They recommend a 135 degree HI prosthesis when RSA is 
used for fractures. 
Cemented versus uncemented RSA has been reviewed and meta analyzed by Rossi LA (2022)38, 
they found similar functional outcomes and reoperation rates with significant higher complication 
rates for uncemented stems. They concluded, that uncemented stem seem to be a valid 
alternative for the management of patients with PHF.   

Fracture pattern and age can´t be the only factors considering treatment options of complex 
proximal humeral fractures, the Charlson Comorbidity Index39 may be used to help decision 
making, too.             
 
 
 

Earlier unpublished results from our department status 
07/23  
 
Delta Xtent FX 
Univers revers FX 
Global FX 
N total 
112 
14 
34 
N female/  median age 
92/77,3 years 
11/76 years 
25/68 years 
N male/ median age 
20/72,5  years 
3/ 66,7 years 
9/ 65,6 
WOOS 3 month 
53 
59 
41 
WOOS 12 m 
65 
71 
40 
WOOS 60 m 
74 
? (missing data) 
37,5 
Elevation 3 month 
80,4 
71,5 
64 
Elevation 12 m 
70 
107  
 
Elevation 60 m 
132 
 
73 
Constant-Murley 3 month 
34 
35 
26 
CMS 12 m 
 
48,7 
 
CMS 60 
52 
 
42 
SSV 3 month 
42 
45 
28 
SSV 12 m 
50 
59 
 
SSV 60 m 
68 
 
36 
Complications/ % 
4/ 3,6 
1/ 7,1 
3/ 8,8 
Death/ % 
13/ 11,6 
1/ 7,1 
9/ 26,4 
 
 
     
 
 
 
Referrences 
 

 
 
 
 
 
 
 
 
 
 
 
   
     
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