NCT05522062

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

August 27, 2022

Last Update Submit

February 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 .

    within one year

Secondary Outcomes (1)

  • To evaluate the effectiveness of surgical management for the different subtypes by follow up patients postoperative .

    within one year

Interventions

surgical treatment for humerus shaft fracture

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Total coverage of all cases with inculsion criteria admitted to AUH in one year

You may qualify if:

  • All patients with traumatic humeral shaft fracture more than 16 years old who are admitted in Assiut University Hospital

You may not qualify if:

  • Patients with humeral shaft fracture less than 16 years old or patients with pathological humeral shaft fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, 71511, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 24241215BACKGROUND
  • 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.

    PMID: 873955BACKGROUND
  • 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.

    PMID: 29292035BACKGROUND
  • 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.

    PMID: 12499966BACKGROUND
  • Horak J, Nilsson BE. Epidemiology of fracture of the upper end of the humerus. Clin Orthop Relat Res. 1975 Oct;(112):250-3.

    PMID: 1192641BACKGROUND

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2022

First Posted

August 30, 2022

Study Start

April 1, 2022

Primary Completion

March 31, 2023

Study Completion

October 1, 2023

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations