Proximal Humerus Fracture Dislocation Direction and Avascular Necrosis

Avascular Necrosis Clinical Trial

— PHF-D  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05735561
• Other study ID #: 2023-006
• Status: Completed
• Start date: February 15, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2023
• Source: Fraser Orthopaedic Research Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 patient reported outcome measures to assess for evidence of avascular necrosis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Avascular Necrosis
• Avascular Necrosis of Humerus
• Dislocation
• Fracture Dislocation
• Fractures, Bone
• Humeral Fractures
• Necrosis
• Osteonecrosis
• Proximal Humeral Fracture
• Shoulder Dislocation
• Shoulder Fractures

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Canada	Royal Columbian Hospital/Fraser Health Authority	New Westminster	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Fraser Orthopaedic Research Society

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of Avascular Necrosis	The presence and advancement of avascular necrosis (as classified by the Cruess Classification System) and as assessed on radiographs.	At least 2 years post fracture fixation
Primary	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.	At least 2 years post fracture fixation
Secondary	DASH (functional outcome)	Asking participants to complete the Disabilities of the Arm, Shoulder, and Hand outcome measure as a way of assessing function.	At least 2 years post fracture fixation
Secondary	Constant Score (functional outcome)	Asking participants to complete the Constant Score patient reported outcome measure as a way of assessing participant function.	At least 2 years post fracture fixation