Proximal Humerus Fracture Dislocation Direction and Avascular Necrosis

NCT05735561 | Completed

• 1 other identifier: 2023-006
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• DASH (functional outcome)

  At least 2 years post fracture fixation

• Constant Score (functional outcome)

  At least 2 years post fracture fixation

Study Arms (4)

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.

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.

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.

Diagnostic Test: X-Ray

Interventions

X-Ray 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 Posterior Dislocation; Proximal Humerus Fracture Valgus Dislocation; Proximal Humerus Fracture Varus Dislocation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Skeletally mature patients who were surgically treated for their proximal humerus fracture dislocation between 2011 and 2021.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fraser Orthopaedic Research Society: lead

Study Sites (1)

Royal Columbian Hospital/Fraser Health Authority

New Westminster, British Columbia, V3L 3W7, Canada

Location

Related Publications (6)

• 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.

  PMID: 29399372 BACKGROUND

• 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.

  PMID: 19100544 BACKGROUND

• 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.

  PMID: 15220884 BACKGROUND

• 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.

  PMID: 26706457 BACKGROUND

• 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.

  PMID: 35605847 BACKGROUND

• 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.

  PMID: 4881164 BACKGROUND

MeSH Terms

Conditions

Shoulder Fractures; Joint Dislocations; Shoulder Dislocation; Osteonecrosis

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Joint Diseases; Musculoskeletal Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Farhad Moola, MD

  FHA Orthopaedic Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 21, 2023
• Study Start: February 15, 2023
• Primary Completion: July 31, 2023
• Study Completion: August 31, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)