Clinical trial NCT05735561: Proximal Humerus Fracture Dislocation Direction and Avascular Necrosis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proximal Humeral Fracture
Dislocation
Dislocation Shoulder
Avascular Necrosis
Avascular Necrosis of Humerus
Lead sponsor: Fraser Orthopaedic Research Society
Sponsor class: NETWORK
First posted: 2023-02-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Skeletally mature patients who were surgically treated for their proximal humerus fracture dislocation between 2011 and 2021.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rates of Avascular Necrosis
timeFrame: At least 2 years post fracture fixation
measure: Direction of the Humeral Fracture Dislocation
timeFrame: At least 2 years post fracture fixation
Secondary outcomes:
measure: DASH (functional outcome)
timeFrame: At least 2 years post fracture fixation
measure: Constant Score (functional outcome)
timeFrame: At least 2 years post fracture fixation
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital/Fraser Health Authority
state: British Columbia
Study officials:
affiliation: FHA Orthopaedic Surgeon
name: Farhad Moola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.