Proximal Humerus Fracture Dislocation Direction and Avascular Necrosis

NCT ID: NCT05735561

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-08-31

Brief Summary

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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

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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

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Proximal Humeral Fracture Dislocation Dislocation Shoulder Avascular Necrosis Avascular Necrosis of Humerus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

X-Ray

Intervention Type DIAGNOSTIC_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.

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.

X-Ray

Intervention Type DIAGNOSTIC_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.

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.

X-Ray

Intervention Type DIAGNOSTIC_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.

Interventions

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X-Ray

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Deceased patients
* Patients unable to complete patient reported outcome measures
* Patients declining to come back to the clinic for updated x-rays
* Dementia
* Incarceration
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fraser Orthopaedic Research Society

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Farhad Moola, MD

Role: PRINCIPAL_INVESTIGATOR

FHA Orthopaedic Surgeon

Locations

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Royal Columbian Hospital/Fraser Health Authority

New Westminster, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 29399372 (View on PubMed)

Greiner 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.

Reference Type BACKGROUND
PMID: 19100544 (View on PubMed)

Hertel 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.

Reference Type BACKGROUND
PMID: 15220884 (View on PubMed)

Boesmueller 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.

Reference Type BACKGROUND
PMID: 26706457 (View on PubMed)

Miltenberg 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.

Reference Type BACKGROUND
PMID: 35605847 (View on PubMed)

Cruess 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.

Reference Type BACKGROUND
PMID: 4881164 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2023-006

Identifier Type: -

Identifier Source: org_study_id

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