Avascular Necrosis Clinical Trial
— PHF-DOfficial title:
Association Between the Direction of Proximal Humerus Fracture Dislocation and Risk of Avascular Necrosis Following Open Reduction Internal Fixation - An Observational, Cohort Study
NCT number | NCT05735561 |
Other study ID # | 2023-006 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 15, 2023 |
Est. completion date | August 31, 2023 |
Verified date | September 2023 |
Source | Fraser Orthopaedic Research Society |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Royal Columbian Hospital/Fraser Health Authority | New Westminster | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Fraser Orthopaedic Research Society |
Canada,
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
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 |
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