- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04578977
Evaluation of Surgical Treatment of Terrible Triade Injury of the Elbow Joint
) Terrible triad injury of the elbow is a complex injury that is classically defined as elbow dislocation along with fractures of the coronoid process of the ulna and the radial head. The injury is usually associated with typical soft-tissue disruptions (with common involvement of the lateral collateral ligament complex, elbow joint capsule, as well as the common extensor and flexor-pronator tendons)(2).
Complications of terrible triad injuries include redislocation, residual instability, elbow stiffness, heterotopic ossification, fracture malunion or nonunion, elbow arthrosis, olecranon bursitis, ulnar or radial nerve palsy (due to the surgical approach or placement of hardware), and hardware related complications(2) .
Management of trrible triade is conservative or surgical treatment ,in this study we will use surgical treatment and make evaluation of it.
Study Overview
Status
Intervention / Treatment
Detailed Description
The elbow is the second most commonly dislocated joint in adults and up to 20% of dislocations are associated with a fracture. (1) Terrible triad injury of the elbow is a complex injury that is classically defined as elbow dislocation along with fractures of the coronoid process of the ulna and the radial head. The injury is usually associated with typical soft-tissue disruptions (with common involvement of the lateral collateral ligament complex, elbow joint capsule, as well as the common extensor and flexor-pronator tendons) Complications of terrible triad injuries include redislocation, residual instability, elbow stiffness, heterotopic ossification, fracture malunion or nonunion, elbow arthrosis, olecranon bursitis, ulnar or radial nerve palsy (due to the surgical approach or placement of hardware), and hardware related complications.
Management of trrible triade is conservative or surgical treatment ,in this study we will use surgical treatment and make evaluation of it.
Surgical treatment involves radial head repair or replacement ,medial and lateral collateral ligament repair and coronoid fracture fixation.
aim of research isFunctional assessment of surgical treatment of terrible triade injury of the elbow according to Mayo elbow performance score, According to the system of Mayo, scores of 90-100 are classified as excellent, 75-89 as good, 60-74 as fair, and 0-59 as poor
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Abdalraouf Mahmoud Ghozaly, resident doctor
- Phone Number: 01555167657
- Email: Abdalraoofmahmoud4@gmail.com
Study Contact Backup
- Name: Hosam Abdalmenem Abu beih, professor
- Phone Number: 01002228963
- Email: hossamabubeih@gmail.com
Study Locations
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Assiut, Egypt
- Recruiting
- Assiut University Hospital
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Principal Investigator:
- Abdalraouf Mahmoud Ghozaly, resident
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1.skeletally mature patients (over 17 years old) including both sexes. 2.Acute fractures within 3 weeks of injury. 3.Isolated & closed fractures . 4.polytrauma trauma patients with no other injuries in the same limb.
Exclusion Criteria:
- 1. pathological fracture of proximal radius and ulna. 2. deteriorateed general health. 3. previous history of dysfunction with the affected elbow.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Surgical Treatment of Terrible Triade Injury of the Elbow joint.
Time Frame: 2 years
|
Functional assessment of surgical treatment of terrible triade injury of the elbow according to Mayo elbow performance score
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abdalraouf Mahmoud Ghozaly, resident doctor, Assiut University
Publications and helpful links
General Publications
- Kani KK, Chew FS. Terrible triad injuries of the elbow. Emerg Radiol. 2019 Jun;26(3):341-347. doi: 10.1007/s10140-019-01676-1. Epub 2019 Jan 28.
- Jones ADR, Jordan RW. Complex Elbow Dislocations and the "Terrible Triad" Injury. Open Orthop J. 2017 Nov 30;11:1394-1404. doi: 10.2174/1874325001711011394. eCollection 2017.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Treatment of Terrible Triade
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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