Association Between the Direction of Proximal Humerus Fracture Dislocation and Risk of Avascular Necrosis Following Open Reduction Internal Fixation - An Observational, Cohort Study
Conditions: Proximal Humeral Fracture, Dislocation, Dislocation Shoulder, Avascular Necrosis, Avascular Necrosis of Humerus
Sponsor: Fraser Orthopaedic Research Society

 
PHF-D Protocol 
V.1.0 
9 January 2023 
 
 
 
 
 
 
 
Association between the direction of proximal humerus fracture dislocation and 
risk of avascular necrosis following open reduction internal fixation- An 
observational, cohort study (PHF-D) 
 
 
 
 
 
 
 
 
 
Study Protocol 
V.1.0 
9 January 2023 
 
 
 
Principal Investigators 
Bert Perey, MD, FRCSC 
 
Farhad Moola, MD, FRCSC 
 
Justin Murphy, MD, FRCSC 
 
 
 
Fraser Orthopaedic Research Society 
Royal Columbian Hospital / Fraser Health Authority 
233 Nelson’s Crst 
New Westminster, BC, Canada 
V3L 0E4 

 
PHF-D Protocol 
V.1.0 
9 January 2023 
 
 
Study Personnel 
 
Principal Investigators: 
 
Bertrand Perey 
 
 
MD, FRCSC 
 
 
 
 
 
Clinical Associate Professor, University of British Columbia 
 
 
 
 
 
#403 233 Nelson’s Crescent 
 
 
 
 
 
New Westminster, BC, Canada, V3L 0E4 
 
 
 
 
 
Tel: 604-777-5577 
 
 
 
 
 
Fax: 604-777-5644 
 
 
 
 
 
E-mail: bperey@shaw.ca 
 
Farhad Moola  
 
 
MD, FRCSC 
 
 
 
 
 
Clinical Associate Professor, University of British Columbia 
 
 
 
 
 
#403 233 Nelson’s Crescent 
 
 
 
 
 
New Westminster, BC, Canada, V3L 0E4 
 
 
 
 
 
Tel: 604-526-4646 
 
 
 
 
 
Fax: 866-883-1615 
 
 
 
 
 
E-mail: fmoola@me.com 
 
Justin Murphy  
 
 
MD, MSc, FRCSC 
Clinical Fellow, Upper Extremity Reconstruction & Trauma 
University of British Columbia 
 
 
 
 
 
E-mail: jrmurphy@mun.ca 
 
 
 
Project Manager: 
 
Ella Spicer 
 
 
 
Clinical Research Coordinator 
 
 
 
 
 
Fraser Orthopaedic Research Society 
 
 
 
 
 
Royal Columbian Hospital 
 
 
 
 
 
#403 233 Nelson’s Crescent 
 
 
 
 
 
New Westminster, BC, Canada, V3L 0E4 
 
 
 
 
 
Tel: 604-553-3247 
 
 
 
 
 
Fax: 1-855-946-1805 
 
 
 
 
 
E-mail: ella.spicer@fraserhealth.ca 
 
 
 
 

 
PHF-D Protocol 
V.1.0 
9 January 2023 
 
Table of Contents 
Study Personnel .............................................................................................................................. 2 
Introduction and Background ......................................................................................................... 4 
Study Objectives ............................................................................................................................. 4 
Primary Objective ....................................................................................................................... 4 
Secondary Objectives .................................................................................................................. 4 
Study Design.................................................................................................................................... 5 
Study Population ............................................................................................................................. 5 
Inclusion criteria.......................................................................................................................... 5 
Exclusion Criteria......................................................................................................................... 5 
Methods .......................................................................................................................................... 5 
Study Visit ................................................................................................................................... 6 
Data Collection ............................................................................................................................ 6 
Outcomes .................................................................................................................................... 7 
Primary Outcome Measure ..................................................................................................... 7 
Secondary Outcome Measure ................................................................................................ 7 
Radiographic Parameters ............................................................................................................ 7 
Statistics .......................................................................................................................................... 7 
Sample Size ................................................................................................................................. 7 
Data Analysis ............................................................................................................................... 7 
Ethical Considerations..................................................................................................................... 8 
Potential Benefits ........................................................................................................................ 8 
Potential Risks ............................................................................................................................. 8 
Data Management .......................................................................................................................... 8 
Confidentiality ............................................................................................................................. 8 
Withdrawal ................................................................................................................................. 9 
Blinding ....................................................................................................................................... 9 
Ethics ........................................................................................................................................... 9 
Publication/Presentations .............................................................................................................. 9 
References .................................................................................................................................... 10 
 
 

 
PHF-D Protocol 
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Introduction and Background 
The incidence of proximal humerus fractures continues to increase and is among one of the 
more common fractures seen in the adult population[1]. Proximal humerus fracture 
dislocations, however, are less common. Despite the decreased prevalence, fracture 
dislocations have unique challenges with respect to obtaining an anatomical reduction and 
more frequently involve an open surgical reduction. In addition, depending on other fracture 
characteristics, there are various treatment options for the fracture itself. Some surgeons may 
try to preserve the native anatomy with a fixation construct, while others may opt for an 
arthroplasty procedure. One of the considerations for joint sparing versus replacement is the 
viability of the humeral head. Previous literature has examined patterns of proximal humerus 
fractures and have suggested predictable indicators that may lead to humeral head avascular 
necrosis (AVN)[2-4]. The study by Hertel et al. (2004) demonstrated various fracture patterns 
associated with an increased risk of AVN. Fracture dislocations were included in the study, 
however, specific details regarding direction of dislocation were not included. More recently, a 
large systematic review by Miltenberg et al. (2022), examined the functional outcomes, rate of 
revision, and short- and long-term complications for proximal humerus fracture dislocations 
treated with open reduction internal fixation[5]. While fracture dislocations ultimately lead to 
increased AVN and revision surgery, further discussion surrounding the direction of dislocation 
and how it may influence overall outcomes was not addressed. 
Study Objectives  
Primary Objective 
The purpose of this study is to first to examine the rates of humeral head AVN in relation to 
direction of proximal humerus fracture dislocation. 
 
Radiographic measures: 
 Humeral head avascular necrosis – as classified by the Cruess classification system[6] 
 Direction of the humeral fracture dislocation – characterized by the direction of humeral 
head in relation to glenoid. Simple objective measure base on A/P, Lateral, and/or 
Axillary Views.  
Secondary Objectives 
Secondarily, this study will address patient reported outcome measures with respect to 
direction of fracture dislocation.  
 
Patient-reported outcome measures: 
- Disabilities of Arm, Shoulder and Hand (DASH) 
- Constant Score (CS) 
 

 
PHF-D Protocol 
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Study Design 
The study will be an observational, cohort study. Participants will be pulled from a retrospective 
cohort of all patients with proximal humerus fracture dislocations who underwent operative 
fixation at Royal Columbian Hospital between January 2011 – July 2021. They will then be 
grouped by their dislocation directions to look at the development of AVN. Eligible patients will 
be given the option to consent to the study. This provisional consent will be obtained over the 
phone, in the form of a verbal agreement. During this agreement the patient will also receive 
an appointment time for them to come into the office. If agreeable, patients will be asked to 
come into the clinic to sign the Informed Consent Form, see their treating surgeon, and 
complete up-to-date radiographs and patient reported outcome measures (PROMs). These 
radiographs and PROMs will be used to assess AVN and overall function.   
Study Population 
Inclusion criteria 
 Patients ≥18 years of age  
 Patients who underwent operative fixation of proximal humerus fracture dislocation at 
Royal Columbian Hospital between January 2011 – July 2021 
 Willing and able to consent and complete patient reported outcome measures 
 Willing and able to follow the protocol and attend a follow-up visit 
 Able to read and understand English or have an interpreter available 
Exclusion Criteria 
 Skeletally immature patients 
 Patients with pathological fractures 
 Patients who have had previous operative fixation of proximal humerus 
 Patients treated non-operatively 
 Patients presenting outside of the study duration window 
 Participants treated by a non-participating surgeon 
 Deceased patients 
 Patients unable to complete patient reported outcome measures 
 Patients declining to come back to the clinic for updated x-rays 
 Dementia 
 Incarceration 
Methods 
All patients deemed appropriate for study inclusion will be determined based on review of 
imaging conducted by an orthopedic attending, fellow, or resident to look for proximal 
humerus fracture dislocations. Patients eligible for study will be grouped based on direction of 
dislocation in one of four groups, anterior, posterior, varus and valgus. Both surgical and  
 

 
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immediate postoperative protocols were left to discretion of attending surgeon, at the time of 
the initial surgery. However, the standard postoperative protocol included an initial follow-up 
for surgical site assessment and removal of sutures and/or staples. In addition, a period of 
restricted activity status was also left to discretion of attending surgeon. 
Study Visit 
Study participants will come back for one visit; this will be an observational visit to see how 
they are doing now. This exam will be conducted in the clinic at a minimum of 2 years 
postoperatively. Vascularity of the humeral head and union of the fracture will be assessed on 
anteroposterior and axial radiographs, while patient reported outcomes will be assessed using  
Constant and Disabilities of Arm, Shoulder and Hand (DASH) Scores.  
The Constant Score (CS) is a 100-point scale (high scores = high level of function) composed of 
individual parameters looking at pain, activities of daily living (ADL), mobility, and measuring 
the strength of the affected shoulder.  
The DASH is a 30-item questionnaire that looks at the ability of a patient to perform certain 
upper extremity activities. The DASH score ranges from 0 (no disability) to 100 (most severe 
disability). 
Data Collection 
Baseline 
- 
Radiographs 
o Dislocation direction 
o Fracture type 
- 
Patient Demographics (Chart Review) 
o Age 
o Gender 
o American Society of Anaesthesiologists (ASA) Score 
o Medical History 
o Social History  
- 
Injury Characteristics 
o Side of injury 
o Mechanism 
o AO/OTA Classification 
Surgical Treatment 
- 
Radiographs 
- 
Surgical Demographics 
o Date of surgery 
o Anaesthesia Type 
o Any Additional Procedures on the Injured Limb 
Observational Visit 
- 
Radiographs 
o AP, Lateral, and Axillary views 
- 
Radiographic outcomes 

 
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o AVN Evidence 
- 
Follow-up Demographics 
o Follow-up Period 
o Date of Last Follow-up 
o Quality of Reduction 
o Re-operations on the Injured Limb 
- 
Patient reported outcomes (DASH, CS) 
Outcomes 
Primary Outcome Measure 
The primary outcome measure is avascular necrosis of the proximal humerus, based on 
radiographic criteria. (Cruess Classification)  
Secondary Outcome Measure 
Patient-reported outcome measures will be collected at the one visit 
 
DASH 
Developed to asses single or multiple musculoskeletal 
disorders affecting the upper limb. The DASH is a very 
commonly used outcome measure that is fully patient-
administered and contains 30-questions designed to 
quantify physical disability and symptoms in individuals 
with upper limb disorders. 
CS 
The constant shoulder score is one of the most commonly 
used outcome measures to asses shoulder disorders. It 
combines subjective and objective measurements in the 
form of: pain, activities of daily living, strength, and range 
of motion to provide you with a final score out of 100. 
Radiographic Parameters 
A/P, Lateral, and Axillary views. 
Statistics 
Sample Size 
Out of a possible 70 participants we hope to enrol around 56 (with approximately 14 in each of 
the 4 dislocation groups). This accounts for 20% of the participants of the total to either choose 
not to enrol or be unavailable due to their morbidity status.  
Data Analysis 
As this is an observational study with limited patient population and no specific time points to 
reference, all participants will have the chance to complete the follow-up visit at their leisure. 
For this reason, we do not foresee needing to exclude any patients for missed appointments. At  
 
 
 

 
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the follow-up visit each participant will be assessed for the presence of AVN in comparison to 
their dislocation direction. Descriptive statistics will be utilized and reported on and parametric 
analysis will be completed as appropriate. 
Ethical Considerations 
Potential Benefits 
It is not known whether or not participants will gain any direct benefit from the study. It is 
possible that participants that come back may still be experiencing some pain or issues in their 
injured limb and want to see the surgeon to discuss potential management.  
 
It is expected that the results of the study will contribute to the literature of shoulder fracture-
dislocations and the development of AVN following this type of injury, and provide a possible 
indication for a large study in the future. 
Potential Risks 
As this is an observational cohort study there are no anticipated risks to participating in the 
study. Treatment has already occurred and all follow-up has been completed as per standard of 
care procedures. The only additional procedures that participants would need to take part in 
for the study are additional radiographs and the completion of one visit that includes 
completing PROMs.  
 
As with all research that includes imaging there is a risk of incidental findings. However, this will 
be dealt with by the most responsible person, who in this case, will be the surgeon that is 
seeing the participant and assessing their radiographs.  
 
Along with research there is also a risk of loss of confidentiality. Every possible step will be 
taken to ensure participant confidentiality.  
Data Management 
Data will be stored in a password protected excel spreadsheet on the FHA M-Drive. Participants 
will be de-identified and receive a unique study ID. There will be a separate, password 
protected excel spreadsheet that will house the participants name and their unique study ID. 
Only necessary study personnel will have access to it.  
Confidentiality 
All data will be identified using a unique number and letter system in the form of a participant 
number. This number (e.g. PHFD-001, PHFD-002, etc) will be the only identifiers used for 
identifying study participants. Most of the data will be electronic and housed in password 
protected servers in the FHA network on the remote drive. Any paper copies of the CRFs or 
consent forms will be kept secure in locked cabinets inside the locked research office.  The 
project manager will authorize personnel to access the data only as necessary.   
 
 

 
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Withdrawal 
As the study consists of one study visit we do not anticipate the need for withdrawal. However, 
participants may choose to withdraw from the study at any time, without any affect to their 
care of treatment. Withdrawal will include the option to withdraw and still have their last 
radiograph assessed for the study, or they can choose to have a complete withdrawal (if they 
haven’t completed the study procedures yet). If the participant has completed the study 
procedures and they choose to withdraw then a discussion will be had about what will happen 
to the information about them already collected. Participants have the right to request the 
destruction of their information collected for the study, or they may choose to leave the study 
and allow the investigators to keep the information already collected. 
 
If participants choose to have the data collected about them destroyed, this will be respected 
to the fullest extend possible. However, there may be exceptions where the data is not able to 
be withdrawn, for example, where the data is no longer identifiable or where the data has been 
merged with other data. If the participant wishes to request the withdrawal of the data, they 
should let their surgeon and/or research team know.  
Blinding 
In order to maintain blinding in the study the initial x-rays, taken when the participant’s 
presented to the emergency department, showing the dislocation direction, will be reviewed 
and assessed by a qualified individual that didn’t perform the surgery. During the one-time 
follow-up visit the surgeon, who performed the participant’s surgery, will assess the x-rays the 
participant had that day to look for any evidence of AVN. The surgeons will be blinded to the 
dislocation direction the participant experienced initially. 
Ethics 
The study protocol, case report forms, questionnaires, and the consent form will be submitted 
and approved by Fraser Health Research Ethics Board prior to study implementation.  
 
The study will be conducted in accordance with the Tri-Council policy statement: Ethical 
Conduct for Research Involving Humans, the International Conference on Harmonisation 
Guidance E6:  Good Clinical Practice E6:  Consolidated Guidelines, applicable government 
regulations, and institutional research policies and procedures. 
Publication/Presentations 
Results from the study will be submitted for publication and presented at national conferences 
as fellow-ship research to influence future studies. 
 
 
 
 
 
 

 
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References 
1. 
Schumaier, A. and B. Grawe, Proximal Humerus Fractures: Evaluation and Management 
in the Elderly Patient. Geriatr Orthop Surg Rehabil, 2018. 9: p. 2151458517750516. 
2. 
Greiner, S., et al., Humeral head necrosis rate at mid-term follow-up after open 
reduction and angular stable plate fixation for proximal humeral fractures. Injury, 2009. 
40(2): p. 186-91. 
3. 
Hertel, R., et al., Predictors of humeral head ischemia after intracapsular fracture of the 
proximal humerus. J Shoulder Elbow Surg, 2004. 13(4): p. 427-33. 
4. 
Boesmueller, S., et al., Risk factors for humeral head necrosis and non-union after 
plating in proximal humeral fractures. Injury, 2016. 47(2): p. 350-5. 
5. 
Miltenberg, B., et al., Fracture dislocations of the proximal humerus treated with open 
reduction and internal fixation: a systematic review. J Shoulder Elbow Surg, 2022. 
31(10): p. e480-e489. 
6. 
Cruess, R.L., et al., Aseptic necrosis following renal transplantation. J Bone Joint Surg 
Am, 1968. 50(8): p. 1577-90.