Treatment of Terrible Triade Injury of the Elbow JointNCT04578977
Evaluation of Surgical Treatment of Terrible Triade Injury of the Elbow Joint
An observational study of Treatment of Terrible Triade Injury of the Elbow Joint, run by Assiut University at 1 site in Egypt.
Trial summary
) 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Treatment of Terrible Triade Injury of the Elbow Joint
- What is being tested?
- Functional assessment of surgical treatment of terrible triade injury of the elbow
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2020to Dec 2022
- 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 17 years and older
- All sexes
- Child, Adult, Older adult
Study population: clinical case series study .
Who may be able to join
- 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.
Who cannot join
- 1. pathological fracture of proximal radius and ulna. 2. deteriorateed general health. 3. previous history of dysfunction with the affected elbow.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut
Abdalraouf Mahmoud Ghozaly, resident
About this study
) 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.
Read the 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
- Being tested
- Functional assessment of surgical treatment of terrible triade injury of the elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional assessment of surgical treatment of terrible triade injury of the elbowBehavioural
Functional assessment of surgical treatment of terrible triade injury of the elbow
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Surgical Treatment of Terrible Triade Injury of the Elbow joint.
Functional assessment of surgical treatment of terrible triade injury of the elbow according to Mayo elbow performance score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start10 Oct 2020 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Treatment of Terrible Triade Injury of the Elbow JointStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abdalraouf mahmoud ghozaly, Assiut University
- Investigators
- Abdalraouf Mahmoud Ghozaly, resident doctor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578977
- Sponsor's protocol ID
- Treatment of Terrible Triade
- Status last verified
- Oct 2020
- First submitted
- 1 Oct 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30690677Jones 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.
PubMed 29290879
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical Treatment of Terrible Triade Injury of the Elbow Joint
- ClinicalTrials.gov ID
- NCT04578977
- Acronym / sponsor ID
- Treatment of Terrible Triade
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2020 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Oct 2020 (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.
) 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- clinical case series study .
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. pathological fracture of proximal radius and ulna. 2. deteriorateed general health. 3. previous history of dysfunction with the affected elbow.
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 |
|---|---|---|
| Functional assessment of surgical treatment of terrible triade injury of the elbowFunctional assessment of surgical treatment of terrible triade injury of the elbow | Behavioural | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 30690677Kani 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.
- Results publication: PubMed 29290879Jones 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.
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.
Abdalraouf Mahmoud Ghozaly, resident doctor principal investigator
Assiut University
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 Treatment of Terrible Triade Injury of the Elbow Joint, 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdalraouf Mahmoud Ghozaly, resident doctor (01555167657, Abdalraoofmahmoud4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Surgical Treatment of Terrible Triade Injury of the Elbow joint. (time frame: 2 years). 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 NCT04578977, which also lists 2 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 8 Oct 2020.