- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05522062
Epidemiological Study for Traumatic Humeral Shaft Fractures in Adults
February 9, 2024 updated by: Youssef Sameh, Assiut University
Epidemiological Study for Traumatic Humeral Shaft Fractures in Adults Who Were Admitted to Assiut University Hospital Within One Year
Primary Objective :
To evaluate the incidence of radial nerve palsy for adult patients with humeral shaft fractures
Secondary Objective :
To establish management protocol for traumatic humeral shaft fractures in adults at AUH
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Diaphyseal humeral shaft fracture is defined as an extra articular fracture of the humerus with Exclusion of both 5 cm of both upper and lower ends (Muller et al,1990) Within the last Century, many conservative and surgical techniques developed all over the world to solve this problem (Welter D et al, 1991) Conservative treatment was a gold standard since the full research which was published by Sarmiento (Sarmiento, 1977 ) Within the last few decades, with the establishment of osteosynthesis and surgical fixation of long bone which had better outcome in comparison to conservative treatment, it led to a changes in the protocols of treating fractures of the humerus (Muller et al,1990) Within the last decade, with the revolution of biological non anatomical fixation of the humeral shaft fractures, a new era of management was established and became popular all over the highly qualified trauma centres (Balam KM et al, 2014) So, the rational of this work, is to document different surgical strategies of biological fixation of humeral shaft fractures in adults with its results.
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt, 71511
- Assiut University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Total coverage of all cases with inculsion criteria admitted to AUH in one year
Description
Inclusion Criteria:
- All patients with traumatic humeral shaft fracture more than 16 years old who are admitted in Assiut University Hospital
Exclusion Criteria:
- Patients with humeral shaft fracture less than 16 years old or patients with pathological humeral shaft fracture
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the occurrence of different patho-anatomic subtypes of humeral shaft fractures and the prevalence of primary radial nerve palsy clinically in patients preoperative and postoperative .
Time Frame: within one year
|
To evaluate the occurrence of different patho-anatomic subtypes of humeral shaft fractures and the prevalence of primary radial nerve palsy clinically in patients preoperative and postoperative .
|
within one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the effectiveness of surgical management for the different subtypes by follow up patients postoperative .
Time Frame: within one year
|
To evaluate the effectiveness of surgical manag ement for the different subtypes by follow up patients postoperative .
|
within one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sarmiento A, Kinman PB, Galvin EG, Schmitt RH, Phillips JG. Functional bracing of fractures of the shaft of the humerus. J Bone Joint Surg Am. 1977 Jul;59(5):596-601.
- Balam KM, Zahrany AS. Posterior percutaneous plating of the humerus. Eur J Orthop Surg Traumatol. 2014 Jul;24(5):763-8. doi: 10.1007/s00590-013-1355-2. Epub 2013 Nov 16.
- Updegrove GF, Mourad W, Abboud JA. Humeral shaft fractures. J Shoulder Elbow Surg. 2018 Apr;27(4):e87-e97. doi: 10.1016/j.jse.2017.10.028. Epub 2017 Dec 29.
- Robinson CM, Hill RM, Jacobs N, Dall G, Court-Brown CM. Adult distal humeral metaphyseal fractures: epidemiology and results of treatment. J Orthop Trauma. 2003 Jan;17(1):38-47. doi: 10.1097/00005131-200301000-00006.
- Horak J, Nilsson BE. Epidemiology of fracture of the upper end of the humerus. Clin Orthop Relat Res. 1975 Oct;(112):250-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
March 31, 2023
Study Completion (Actual)
October 1, 2023
Study Registration Dates
First Submitted
August 27, 2022
First Submitted That Met QC Criteria
August 29, 2022
First Posted (Actual)
August 30, 2022
Study Record Updates
Last Update Posted (Actual)
February 12, 2024
Last Update Submitted That Met QC Criteria
February 9, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Humeral shaft fracture
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Humerus Shaft Fracture
-
Kolding SygehusOdense University Hospital; Karolinska University Hospital; Zealand University... and other collaboratorsRecruitingFracture Humerus of ShaftSweden, Finland, Denmark, Norway
-
Federal University of São PauloUnknownHumerus Fracture | Fracture of Shaft of HumerusBrazil
-
Oregon Health and Science UniversityCompletedFracture of Shaft of HumerusUnited States
-
Royal Infirmary of EdinburghUniversity of Edinburgh; NHS LothianCompleted
-
St. Louis UniversityBoston Medical Center; Vanderbilt University; Indiana University; Prisma Health-Midlands and other collaboratorsCompletedClosed Fracture of Shaft of HumerusUnited States
-
Fraser Orthopaedic Research SocietyRecruitingHumerus Shaft Fracture | Elderly (people Aged 65 or More)Canada
-
Charite University, Berlin, GermanyJena University Hospital; Beckman Coulter, Inc.; University Hospital Dresden; Unfallkrankenhaus... and other collaboratorsRecruitingFemoral Neck Fractures | Femoral Shaft Fracture | Tibial Shaft Fracture | Forearm Fracture | Fracture Non Union | Distal Tibia Fracture | Fracture Healing | Femur Distal Fracture | Proximal Tibia Fracture | Humerus Shaft Fracture | Long Bone Delayed-Union Fracture | Pertrochanteric Fracture of FemurGermany
-
Istanbul Medeniyet UniversityRecruitingRadial Nerve Palsy | Humerus Shaft FractureTurkey (Türkiye)
-
University of Kansas Medical CenterRecruitingFemoral Neck Fractures | Distal Radius Fractures | Femoral Shaft Fracture | Intertrochanteric Fractures | Patella Fracture | Lisfranc Injuries | Distal Femur Fracture | Calcaneus Fractures | Clavicle Fractures | Proximal Humerus Fractures | Tibial Pilon Fracture | Talar Head, Neck, Body, or Process Fractures | Isolated... and other conditionsUnited States
-
NYU Langone HealthWithdrawnFemoral Shaft Fracture | Tibial Shaft FractureUnited States
Clinical Trials on surgical treatment for humerus shaft fracture
-
Nanjing First Hospital, Nanjing Medical UniversityCompleted
-
Consorci Sanitari de TerrassaRecruiting
-
University of Maryland, BaltimoreNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not yet recruitingPelvic Fractures | Fragility Fractures of the Pelvis (FFP)
-
Herlev and Gentofte HospitalRecruitingIntra-Articular Fractures | Distal Humerus Fracture | Comminuted FractureDenmark
-
Sahlgrenska University HospitalVastra Gotaland RegionRecruiting
-
AO Clinical Investigation and Publishing DocumentationTerminatedMandibular FracturesSpain, United States, Netherlands, Sweden, Finland, Taiwan, South Africa, Switzerland, Germany, Malaysia, Mexico, Uruguay, Romania, Serbia, Slovenia
-
Tribhuvan University, NepalUnknownOral and Maxillofacial InjuriesNepal
-
Mikel AburtoCompleted
-
Cellontech Co., Ltd.TerminatedFemur Fracture | Bone Fracture | Tibia FractureSouth Korea
-
Ente Ospedaliero Cantonale, BellinzonaRecruiting