Proximal Humeral FracturePHF-DNCT05735561
Proximal Humerus Fracture Dislocation Direction and Avascular Necrosis
An observational study of Proximal Humeral Fracture and Dislocation, run by Fraser Orthopaedic Research Society at 1 site in Canada.
Trial summary
The purpose of the study is to see if there is a connection between a proximal humerus fracture dislocation direction and the likelihood of developing avascular necrosis. Utilizing a retrospective cohort from the last ten years we hope to bring consenting patients back for a single visit to have x-rays and complete… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humeral Fracture, Dislocation, Dislocation Shoulder
- What is being tested?
- X-Ray
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2023to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Skeletally mature patients who were surgically treated for their proximal humerus fracture dislocation between 2011 and 2021.
Who may be able to join
- Patients 18 years of age or older
- Patients who underwent operative fixation of proximal humerus fracture dislocation at Royal Columbian Hospital between January 2011 and 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
Who cannot join
- Skeletally immature patients
- Patient 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
- Patients treated by a non-participating surgeon
Show all 11Show fewer
- Deceased patients
- Patients unable to complete patient reported outcome measures
- Patients declining to come back to the clinic for updated x-rays
- Dementia
- Incarceration
Trial locations and contacts
1 site in 1 country.
Canada1 site
Royal Columbian Hospital/Fraser Health Authority
New Westminster, British Columbia, V3L 3W7
About this study
Official title: Association Between the Direction of Proximal Humerus Fracture Dislocation and Risk of Avascular Necrosis Following Open Reduction Internal Fixation - An Observational, Cohort Study
The purpose of the study is to see if there is a connection between a proximal humerus fracture dislocation direction and the likelihood of developing avascular necrosis. Utilizing a retrospective cohort from the last ten years we hope to bring consenting patients back for a single visit to have x-rays and complete patient reported outcome measures to assess for evidence of avascular necrosis.
Read the detailed description
The incidence of proximal humerus fractures continues to increase and is among one of the more common fractures seen in the adult population. 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. 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 has not been addressed in the previous literature. The study design utilizes a retrospective cohort from the last ten years, by asking patients who have had a previously surgically treated proximal humerus fracture dislocations to come back to the surgeon's private clinic to complete a single visit assessment. During this assessment the consenting participant will receive x-rays and complete patient reported outcome measures. In conjunction, these will be utilized to assess overall function and the existence of avascular necrosis.
- Conditions
- Proximal Humeral Fracture, Dislocation, Dislocation Shoulder, Avascular Necrosis, Avascular Necrosis of Humerus
- Being tested
- X-Ray
- Medical subject headings
- Shoulder Fractures, Joint Dislocations, Shoulder Dislocation, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-RayDiagnostic test
Consenting participants will be asked to come into the clinic for a single visit, during this visit they will be asked to complete an x-ray to check for evidence of avascular necrosis.
| Study group | Role | What they receive |
|---|---|---|
| Proximal Humerus Fracture Anterior Dislocation | The study doesn't provide any intervention. This group is defined as having a dislocation that is anterior to the glenoid. | |
| Proximal Humerus Fracture Posterior Dislocation | The study doesn't provide any intervention. This group is defined as having a dislocation that is posterior to the glenoid. Receives: Diagnostic Test: X-Ray | |
| Proximal Humerus Fracture Varus Dislocation | The study doesn't provide any intervention. This group is defined as having a dislocation that is in varus compared to the glenoid. Receives: Diagnostic Test: X-Ray | |
| Proximal Humerus Fracture Valgus Dislocation | The study doesn't provide any intervention. This group is defined as having a dislocation that is in valgus compared to the gelnoid. Receives: Diagnostic Test: X-Ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Avascular Necrosis
The presence and advancement of avascular necrosis (as classified by the Cruess Classification System) and as assessed on radiographs.
Measured: At least 2 years post fracture fixation
Direction of the Humeral Fracture Dislocation
As characterized by the direction of the humeral head in relation to the glenoid, based on AP, Lateral, or Axillary x-ray views.
Measured: At least 2 years post fracture fixation
Secondary outcomes (2)
DASH (functional outcome)
Asking participants to complete the Disabilities of the Arm, Shoulder, and Hand outcome measure as a way of assessing function.
Measured: At least 2 years post fracture fixation
Constant Score (functional outcome)
Asking participants to complete the Constant Score patient reported outcome measure as a way of assessing participant function.
Measured: At least 2 years post fracture fixation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start15 Feb 2023
- Primary completion31 Jul 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Proximal Humeral FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Orthopaedic Research Society
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Farhad Moola, MD, Principal investigator, FHA Orthopaedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735561
- Sponsor's protocol ID
- 2023-006
- Acronym
- PHF-D
- Status last verified
- Sep 2023
- First submitted
- 27 Jan 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data with other researchers, results will of course be shared. However, the hope is that the study might indicate a need for a high powered prospective clinical trial to be completed.
Publications
Schumaier A, Grawe B. Proximal Humerus Fractures: Evaluation and Management in the Elderly Patient. Geriatr Orthop Surg Rehabil. 2018 Jan 25;9:2151458517750516. doi: 10.1177/2151458517750516. eCollection 2018.
PubMed 29399372Greiner S, Kaab MJ, Haas NP, Bail HJ. Humeral head necrosis rate at mid-term follow-up after open reduction and angular stable plate fixation for proximal humeral fractures. Injury. 2009 Feb;40(2):186-91. doi: 10.1016/j.injury.2008.05.030. Epub 2008 Dec 18.
PubMed 19100544Hertel R, Hempfing A, Stiehler M, Leunig M. Predictors of humeral head ischemia after intracapsular fracture of the proximal humerus. J Shoulder Elbow Surg. 2004 Jul-Aug;13(4):427-33. doi: 10.1016/j.jse.2004.01.034.
PubMed 15220884Boesmueller S, Wech M, Gregori M, Domaszewski F, Bukaty A, Fialka C, Albrecht C. Risk factors for humeral head necrosis and non-union after plating in proximal humeral fractures. Injury. 2016 Feb;47(2):350-5. doi: 10.1016/j.injury.2015.10.001. Epub 2015 Oct 22.
PubMed 26706457Miltenberg B, Masood R, Katsiaunis A, Moverman MA, Puzzitiello RN, Pagani NR, Menendez ME, Salzler MJ, Drager J. Fracture dislocations of the proximal humerus treated with open reduction and internal fixation: a systematic review. J Shoulder Elbow Surg. 2022 Oct;31(10):e480-e489. doi: 10.1016/j.jse.2022.04.018. Epub 2022 May 20.
PubMed 35605847Cruess RL, Blennerhassett J, MacDonald FR, MacLean LD, Dossetor J. Aseptic necrosis following renal transplantation. J Bone Joint Surg Am. 1968 Dec;50(8):1577-90. No abstract available.
PubMed 4881164
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between the Direction of Proximal Humerus Fracture Dislocation and Risk of Avascular Necrosis Following Open Reduction Internal Fixation - An Observational, Cohort Study
- ClinicalTrials.gov ID
- NCT05735561
- Acronym / sponsor ID
- PHF-D / 2023-006
- Conditions
- Proximal Humeral Fracture, Dislocation, Dislocation Shoulder, Avascular Necrosis, Avascular Necrosis of Humerus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fraser Orthopaedic Research SocietyResearch network
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to see if there is a connection between a proximal humerus fracture dislocation direction and the likelihood of developing avascular necrosis. Utilizing a retrospective cohort from the last ten years we hope to bring consenting patients back for a single visit to have x-rays and complete patient reported outcome measures to assess for evidence of avascular necrosis.
Detailed description
The incidence of proximal humerus fractures continues to increase and is among one of the more common fractures seen in the adult population. 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. 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 has not been addressed in the previous literature. The study design utilizes a retrospective cohort from the last ten years, by asking patients who have had a previously surgically treated proximal humerus fracture dislocations to come back to the surgeon's private clinic to complete a single visit assessment. During this assessment the consenting participant will receive x-rays and complete patient reported outcome measures. In conjunction, these will be utilized to assess overall function and the existence of avascular necrosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Proximal Humerus Fracture Anterior Dislocation | – | –The study doesn't provide any intervention. This group is defined as having a dislocation that is anterior to the glenoid. |
| Proximal Humerus Fracture Posterior Dislocation | – | Diagnostic Test: X-RayThe study doesn't provide any intervention. This group is defined as having a dislocation that is posterior to the glenoid. |
| Proximal Humerus Fracture Varus Dislocation | – | Diagnostic Test: X-RayThe study doesn't provide any intervention. This group is defined as having a dislocation that is in varus compared to the glenoid. |
| Proximal Humerus Fracture Valgus Dislocation | – | Diagnostic Test: X-RayThe study doesn't provide any intervention. This group is defined as having a dislocation that is in valgus compared to the gelnoid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Skeletally mature patients who were surgically treated for their proximal humerus fracture dislocation between 2011 and 2021.
Key inclusion criteria (5 listed)
- Patients 18 years of age or older
- Patients who underwent operative fixation of proximal humerus fracture dislocation at Royal Columbian Hospital between January 2011 and 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
Key exclusion criteria (11 listed)
- Skeletally immature patients
- Patient 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X-RayConsenting participants will be asked to come into the clinic for a single visit, during this visit they will be asked to complete an x-ray to check for evidence of avascular necrosis. | Diagnostic test | Proximal Humerus Fracture Posterior Dislocation, Proximal Humerus Fracture Valgus Dislocation, Proximal Humerus Fracture Varus Dislocation |
Primary outcome
Rates of Avascular Necrosis
Time frame: At least 2 years post fracture fixation
The presence and advancement of avascular necrosis (as classified by the Cruess Classification System) and as assessed on radiographs.
Direction of the Humeral Fracture Dislocation
Time frame: At least 2 years post fracture fixation
As characterized by the direction of the humeral head in relation to the glenoid, based on AP, Lateral, or Axillary x-ray views.
2 secondary outcomes
DASH (functional outcome)
Time frame: At least 2 years post fracture fixation
Constant Score (functional outcome)
Time frame: At least 2 years post fracture fixation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 29399372Schumaier A, Grawe B. Proximal Humerus Fractures: Evaluation and Management in the Elderly Patient. Geriatr Orthop Surg Rehabil. 2018 Jan 25;9:2151458517750516. doi: 10.1177/2151458517750516. eCollection 2018.
- Background: PubMed 19100544Greiner S, Kaab MJ, Haas NP, Bail HJ. Humeral head necrosis rate at mid-term follow-up after open reduction and angular stable plate fixation for proximal humeral fractures. Injury. 2009 Feb;40(2):186-91. doi: 10.1016/j.injury.2008.05.030. Epub 2008 Dec 18.
- Background: PubMed 15220884Hertel R, Hempfing A, Stiehler M, Leunig M. Predictors of humeral head ischemia after intracapsular fracture of the proximal humerus. J Shoulder Elbow Surg. 2004 Jul-Aug;13(4):427-33. doi: 10.1016/j.jse.2004.01.034.
- Background: PubMed 26706457Boesmueller S, Wech M, Gregori M, Domaszewski F, Bukaty A, Fialka C, Albrecht C. Risk factors for humeral head necrosis and non-union after plating in proximal humeral fractures. Injury. 2016 Feb;47(2):350-5. doi: 10.1016/j.injury.2015.10.001. Epub 2015 Oct 22.
- Background: PubMed 35605847Miltenberg B, Masood R, Katsiaunis A, Moverman MA, Puzzitiello RN, Pagani NR, Menendez ME, Salzler MJ, Drager J. Fracture dislocations of the proximal humerus treated with open reduction and internal fixation: a systematic review. J Shoulder Elbow Surg. 2022 Oct;31(10):e480-e489. doi: 10.1016/j.jse.2022.04.018. Epub 2022 May 20.
- Background: PubMed 4881164Cruess RL, Blennerhassett J, MacDonald FR, MacLean LD, Dossetor J. Aseptic necrosis following renal transplantation. J Bone Joint Surg Am. 1968 Dec;50(8):1577-90. No abstract available.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data with other researchers, results will of course be shared. However, the hope is that the study might indicate a need for a high powered prospective clinical trial to be completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farhad Moola, MD principal investigator
FHA Orthopaedic Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humeral Fracture and Dislocation, run by Fraser Orthopaedic Research Society at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Avascular Necrosis (time frame: At least 2 years post fracture fixation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05735561, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023; AzTrials last refreshed its copy on 31 Oct 2026.