Humerus Shaft FractureNCT05522062
Epidemiological Study for Traumatic Humeral Shaft Fractures in Adults
An observational study of Humerus Shaft Fracture, run by Assiut University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Humerus Shaft Fracture
- What is being tested?
- surgical treatment for humerus shaft fracture
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Total coverage of all cases with inculsion criteria admitted to AUH in one year
Who may be able to join
- All patients with traumatic humeral shaft fracture more than 16 years old who are admitted in Assiut University Hospital
Who cannot join
- Patients with humeral shaft fracture less than 16 years old or patients with pathological humeral shaft fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Humerus Shaft Fracture
- Being tested
- surgical treatment for humerus shaft fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical treatment for humerus shaft fractureProcedure or surgery
surgical treatment for humerus shaft fracture
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
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 .
Measured: within one year
Secondary outcomes (1)
To evaluate the effectiveness of surgical management for the different subtypes by follow up patients postoperative .
To evaluate the effectiveness of surgical manag ement for the different subtypes by follow up patients postoperative .
Measured: within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Apr 2022
- Primary completion31 Mar 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Humerus Shaft FractureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youssef Sameh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522062
- Sponsor's protocol ID
- Humeral shaft fracture
- Status last verified
- Feb 2024
- First submitted
- 27 Aug 2022
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24241215Sarmiento 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.
PubMed 873955Updegrove 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.
PubMed 29292035Robinson 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.
PubMed 12499966Horak J, Nilsson BE. Epidemiology of fracture of the upper end of the humerus. Clin Orthop Relat Res. 1975 Oct;(112):250-3.
PubMed 1192641
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study for Traumatic Humeral Shaft Fractures in Adults Who Were Admitted to Assiut University Hospital Within One Year
- ClinicalTrials.gov ID
- NCT05522062
- Acronym / sponsor ID
- Humeral shaft fracture
- Conditions
- Humerus Shaft Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Total coverage of all cases with inculsion criteria admitted to AUH in one year
Key inclusion criteria (1 listed)
- All patients with traumatic humeral shaft fracture more than 16 years old who are admitted in Assiut University Hospital
Key exclusion criteria (1 listed)
- Patients with humeral shaft fracture less than 16 years old or patients with pathological humeral shaft fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical treatment for humerus shaft fracturesurgical treatment for humerus shaft fracture | Procedure or surgery | – |
Primary outcome
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 .
1 secondary outcome
To evaluate the effectiveness of surgical management for the different subtypes by follow up patients postoperative .
Time frame: within one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Background: PubMed 24241215Balam 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.
- Background: PubMed 873955Sarmiento 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.
- Background: PubMed 29292035Updegrove 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.
- Background: PubMed 12499966Robinson 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.
- Background: PubMed 1192641Horak J, Nilsson BE. Epidemiology of fracture of the upper end of the humerus. Clin Orthop Relat Res. 1975 Oct;(112):250-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Humerus Shaft Fracture, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05522062, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.