Elbow InjuryNCT05687734
Outcome of Failed and Neglected Terrible Triad Injury of the Elbow
An observational study of Elbow Injury, run by Assiut University.
Trial summary
The aim of the study is to evaluate the results of reconstruction of neglected and failed cases of terrible triad of the elbow Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Elbow Injury
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 30 Dec 2024
- 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 15 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: • All cases fulfilling the Inclusion and Exclusion Criteria admitted to Assuit university over two year from the beginning of the study.
Who may be able to join
- • Age from 15 to 70 years' old
- Neglected cases more than 4 weeks
- Early failed cases whom had any intervention whether conservative treatment as cast or hinged elbow brace etc or operative and still complaining of instability of the elbow. In less than 6 weeks
- Late Failed cases whom had any intervention whether conservative treatment as cast or hinged elbow brace etc or operative and still complaining of instability of the elbow after more than 6 weeks .
Who cannot join
- • Older than 70 years old and younger than 15 years old
- Nerve injury
- Associated soft tissue loss
- Patients needs Total Elbow Replacement or Arthrodesis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcome of Reconstruction of Failed and Neglected Terrible Triad Injury of the Elbow
The aim of the study is to evaluate the results of reconstruction of neglected and failed cases of terrible triad of the elbow
Read the detailed description
A terrible triad injury consists of posterior dislocation of the elbow associated with a radial head fracture and a coronoid fracture. This injury occurs during a fall onto an outstretched arm, and it presents a disruption of the bony and capsuloligamentous structures from the lateral side, which progresses anteriorly and medially.The primary goal of surgical treatment for terrible triad injury is to restore elbow function with. good stability. The current standard treatment involves internal fixation and reconstruction of the bony and ligamentous structures to allow early mobilization. Fixation or replacement of radial head fractures and lateral ligament reconstruction represent the main operative procedures. A biomechanical and clinical study showed that restoration of the coronoid process and anterior capsule is an important step for a stable elbow. old "terrible triad" of elbow with no operative history is difficult to treat. The elbow's functions and stabilization can be recovered by thorough elbow release, repair of coronoid process and anterior capsule, radial head fixation or replacment reconstruction or repaire of, lateral collateral ligament and reinsertion of the common extensor tendon, combined with hinged external fixator Although improved knowledge of this injury has yielded favourable clinical outcomes, complications continue to occur, including stiffness, recurrent subluxation or dislocation, heterotopic ossification, ulnar nerve neuropathy, and arthritis.The common causes of revision after terrible triad injury reconstruction are stiffness and recurrent instability, Stiffness and instability, among all these complications, are indeed the most recurring. A stiff or unstable elbow is very poorly tolerated because of the lack of compensatory motion in adjacent joints, So it's very important to detect causes and risk factors that leading to fail terrible triad reconstruction.
- Conditions
- Elbow Injury
- Medical subject headings
- Elbow Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
The final end results will be assessed according to degree of improvement according to DASH score performance index
The final end results will be assessed according to degree of improvement according to DASH score performance index (The disability of the arm, shoulder and hand)(is an upper-extremity specific outcome measure that was introduced by the American Academy of Orthopedic Surgeons in collaboration with a number of other organizations)(The main part of the DASH is a 30-item disability/symptom scale concerning the patient's health status during the preceding week. The items ask about the degree of difficulty in performing different physical activities because of the arm, shoulder, or hand problem (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (5 items), as well as the problem's impact on social activities, work, sleep, and self-image (4 items). Each item has five response options. The scores for all items are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability).
Measured: DASH score assessment preoperative and at 4,8 weeks 6 months and 1 year postoperative.Follow up:2 weeks postoperative for stitches removal, 6 weeks by x ray to assess reunion, 3 and 6 months by x ray to assess reunion.1 year by MSCT to assess reunion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Mar 2023 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Elbow InjuryStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mo'men Moustafa Mohamed Saber, Assiut University
- Investigators
- Aly Mohamden Mohamed, Professor, Study director, Assiut UniversityWaleed Riad Saleh, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687734
- Sponsor's protocol ID
- Outcome of elbow injury
- Status last verified
- Jan 2023
- First submitted
- 15 Dec 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kachooei AR, Mellema JJ, Tarabochia MA, Chen N, van Dijk CN, Ring D. Involvement of the lesser sigmoid notch in elbow fracture dislocations. J Shoulder Elbow Surg. 2016 Oct;25(10):1571-6. doi: 10.1016/j.jse.2016.02.013. Epub 2016 May 24.
PubMed 27233485Giannicola G, Calella P, Piccioli A, Scacchi M, Gumina S. Terrible triad of the elbow: is it still a troublesome injury? Injury. 2015 Dec;46 Suppl 8:S68-76. doi: 10.1016/S0020-1383(15)30058-9.
PubMed 26747922Zhang J, Tan M, Kwek EBK. Outcomes of coronoid-first repair in terrible triad injuries of the elbow. Arch Orthop Trauma Surg. 2017 Sep;137(9):1239-1245. doi: 10.1007/s00402-017-2733-8. Epub 2017 Jun 20.
PubMed 28634742Fitzgibbons PG, Louie D, Dyer GS, Blazar P, Earp B. Functional outcomes after fixation of "terrible triad" elbow fracture dislocations. Orthopedics. 2014 Apr;37(4):e373-6. doi: 10.3928/01477447-20140401-59.
PubMed 24762843Ritali A, Rotini R, Cavallo M, Marinelli A, Guerra E. Instability/stiffness in elbow fracture dislocation. Lo Scalpello-Journal. 2020 Mar 22;34:30-5.
Sun Z, Li J, Luo G, Wang F, Hu Y, Fan C. What constitutes a clinically important change in Mayo Elbow Performance Index and range of movement after open elbow arthrolysis? Bone Joint J. 2021 Feb;103-B(2):366-372. doi: 10.1302/0301-620X.103B2.BJJ-2020-0259.R3.
PubMed 33517717
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Reconstruction of Failed and Neglected Terrible Triad Injury of the Elbow
- ClinicalTrials.gov ID
- NCT05687734
- Acronym / sponsor ID
- Outcome of elbow injury
- Conditions
- Elbow Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 18 Jan 2023 (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.
The aim of the study is to evaluate the results of reconstruction of neglected and failed cases of terrible triad of the elbow
Detailed description
A terrible triad injury consists of posterior dislocation of the elbow associated with a radial head fracture and a coronoid fracture. This injury occurs during a fall onto an outstretched arm, and it presents a disruption of the bony and capsuloligamentous structures from the lateral side, which progresses anteriorly and medially.The primary goal of surgical treatment for terrible triad injury is to restore elbow function with. good stability. The current standard treatment involves internal fixation and reconstruction of the bony and ligamentous structures to allow early mobilization. Fixation or replacement of radial head fractures and lateral ligament reconstruction represent the main operative procedures. A biomechanical and clinical study showed that restoration of the coronoid process and anterior capsule is an important step for a stable elbow. old "terrible triad" of elbow with no operative history is difficult to treat. The elbow's functions and stabilization can be recovered by thorough elbow release, repair of coronoid process and anterior capsule, radial head fixation or replacment reconstruction or repaire of, lateral collateral ligament and reinsertion of the common extensor tendon, combined with hinged external fixator Although improved knowledge of this injury has yielded favourable clinical outcomes, complications continue to occur, including stiffness, recurrent subluxation or dislocation, heterotopic ossification, ulnar nerve neuropathy, and arthritis.The common causes of revision after terrible triad injury reconstruction are stiffness and recurrent instability, Stiffness and instability, among all these complications, are indeed the most recurring. A stiff or unstable elbow is very poorly tolerated because of the lack of compensatory motion in adjacent joints, So it's very important to detect causes and risk factors that leading to fail terrible triad reconstruction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- • All cases fulfilling the Inclusion and Exclusion Criteria admitted to Assuit university over two year from the beginning of the study.
Key inclusion criteria (4 listed)
- • Age from 15 to 70 years' old
Key exclusion criteria (4 listed)
- • Older than 70 years old and younger than 15 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The final end results will be assessed according to degree of improvement according to DASH score performance index
Time frame: DASH score assessment preoperative and at 4,8 weeks 6 months and 1 year postoperative.Follow up:2 weeks postoperative for stitches removal, 6 weeks by x ray to assess reunion, 3 and 6 months by x ray to assess reunion.1 year by MSCT to assess reunion
The final end results will be assessed according to degree of improvement according to DASH score performance index (The disability of the arm, shoulder and hand)(is an upper-extremity specific outcome measure that was introduced by the American Academy of Orthopedic Surgeons in collaboration with a number of other organizations)(The main part of the DASH is a 30-item disability/symptom scale concerning the patient's health status during the preceding week. The items ask about the degree of difficulty in performing different physical activities because of the arm, shoulder, or hand problem (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (5 items), as well as the problem's impact on social activities, work, sleep, and self-image (4 items). Each item has five response options. The scores for all items are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Background: PubMed 27233485Kachooei AR, Mellema JJ, Tarabochia MA, Chen N, van Dijk CN, Ring D. Involvement of the lesser sigmoid notch in elbow fracture dislocations. J Shoulder Elbow Surg. 2016 Oct;25(10):1571-6. doi: 10.1016/j.jse.2016.02.013. Epub 2016 May 24.
- Background: PubMed 26747922Giannicola G, Calella P, Piccioli A, Scacchi M, Gumina S. Terrible triad of the elbow: is it still a troublesome injury? Injury. 2015 Dec;46 Suppl 8:S68-76. doi: 10.1016/S0020-1383(15)30058-9.
- Background: PubMed 28634742Zhang J, Tan M, Kwek EBK. Outcomes of coronoid-first repair in terrible triad injuries of the elbow. Arch Orthop Trauma Surg. 2017 Sep;137(9):1239-1245. doi: 10.1007/s00402-017-2733-8. Epub 2017 Jun 20.
- Background: PubMed 24762843Fitzgibbons PG, Louie D, Dyer GS, Blazar P, Earp B. Functional outcomes after fixation of "terrible triad" elbow fracture dislocations. Orthopedics. 2014 Apr;37(4):e373-6. doi: 10.3928/01477447-20140401-59.
- BackgroundRitali A, Rotini R, Cavallo M, Marinelli A, Guerra E. Instability/stiffness in elbow fracture dislocation. Lo Scalpello-Journal. 2020 Mar 22;34:30-5.
- Background: PubMed 33517717Sun Z, Li J, Luo G, Wang F, Hu Y, Fan C. What constitutes a clinically important change in Mayo Elbow Performance Index and range of movement after open elbow arthrolysis? Bone Joint J. 2021 Feb;103-B(2):366-372. doi: 10.1302/0301-620X.103B2.BJJ-2020-0259.R3.
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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.
Aly Mohamden Mohamed, Professor study director
Assiut University
Waleed Riad Saleh, Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Elbow Injury, run by Assiut University.
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 4 inclusion and 4 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 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Momen Moustafa Mohamed, specialist (+201141130033, momenmoustafa87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The final end results will be assessed according to degree of improvement according to DASH score performance index (time frame: DASH score assessment preoperative and at 4,8 weeks 6 months and 1 year postoperative.Follow up:2 weeks postoperative for stitches removal, 6 weeks by x ray to assess reunion, 3 and 6 months by x ray to assess reunion.1 year by MSCT to assess reunion). 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 NCT05687734, which also lists 6 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 18 Jan 2023.