Proximal Humerus Fracture Dislocation Direction and Avascular Necrosis
NCT ID: NCT05735561
Last Updated: 2023-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
25 participants
OBSERVATIONAL
2023-02-15
2023-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective Evaluation of the Clinical Profile and Treatment Outcomes of Proximal Humerus Fractures.
NCT05005364
CT Imaging Evaluation of Humerus Fractures
NCT02170545
Researches About Proximal Humerus Fractures
NCT04523415
Proximal Humerus Fractures: A Retrospective Analysis
NCT03637608
Femoral Neck Fracture in Adult and Avascular Necrosis and Nonunion
NCT03666637
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
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
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
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fraser Orthopaedic Research Society
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Farhad Moola, MD
Role: PRINCIPAL_INVESTIGATOR
FHA Orthopaedic Surgeon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Columbian Hospital/Fraser Health Authority
New Westminster, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.