Clavicular FractureNCT03462901
Fixation of Displaced Midshaft Clavicular Fractures in Adults by Intramedullary Elastic Rod
A study testing Percutaneous intramedullary fixation of displaced midshaft clavicular fractures . in people with Clavicular Fracture, run by Assiut University.
Trial summary
Clavicular fracture, constitutes 2.6% e 5% of all adult fractures, most are located in the midshaft clavicle with different degrees of displacement. Conservative methods are commonly used for midshaft clavicular fractures treatment, but with various unsatisfactory complications such as nonunion, malunion and shoulders… Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Clavicular Fracture
- What is being tested?
- Percutaneous intramedullary fixation of displaced midshaft clavicular fractures .
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2016to 21 May 2019
- Phase
- Interventional
- 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 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Adults pt aged (16-55 ) how is active presented with mid shaft clavicular fracture, displacement with no comorbidity and excluding pt with polytrauma aged above 55y or below 16y ,pt with fracture lateral 3rd and pt with comorbidity
About this study
Clavicular fracture, constitutes 2.6% e 5% of all adult fractures, most are located in the midshaft clavicle with different degrees of displacement. Conservative methods are commonly used for midshaft clavicular fractures treatment, but with various unsatisfactory complications such as nonunion, malunion and shoulders asymmetry. The rate of malunion after conservative treatment for the midshaft clavicular fractures reached 15%, and 30% patients were unsatisfied. Recently, early midshaft clavicular fractures could greatly reduce the incidence rate of nonunion and malunion. Open reduction and plate-screw fixation was considered as the gold standard with the advantages of firm fixation and earlier postoperative mobilization, but also with disadvantages of larger incision and more organizations being exposed, presenting with many postoperative complications. Intramedullary fixation treatment for mid-clavicular fractures has been favored due to its strengths including small incision, less periosteal striping, dispersion of stress and simple to operate However, early intra-medullary implants, such as Hagie pins and Kirschner wires, have been gradually replaced due to insufficient stability. In addition, various nails such as elastic stable intramedullar
Read the detailed description
Fixation of displaced midshaft clavicular fractures with minimally invasive technic as it helps for early mobilization to the shoulder and more safe, more cosmetically in comparison to other options.
- Conditions
- Clavicular Fracture
- Being tested
- Percutaneous intramedullary fixation of displaced midshaft clavicular fractures .
- Keywords
- Fixation of midshaft clavicular fracture by intramedullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous intramedullary fixation of displaced midshaft clavicular fractures .Procedure or surgery
Also called Intramedulary fixation of clavicular fractures
A group of 15 patients admitted to Assiut university with midshaft clavicular fractures treated by operative fixation of the fracture by single elastic rod through medial approach under image intensifier
| Study group | Role | What they receive |
|---|---|---|
| Elastic rod fixation | Experimental | Percutaneous intramedullary fixation of displaced midshaft clavicular fractures Receives: Procedure: Percutaneous intramedullary fixation of displaced midshaft clavicular fractures . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Union rate
We will compares rat of union between fixation of clavicular fracture by intramedullary elastic rod and other methods of fixation
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start30 Oct 2016
- Primary completion20 Oct 2018 (estimated)
- Study completion21 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicular 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Fracture clavicle in adults
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Ebrahem Kenan, Assiut University
- Investigators
- Faisal Fahmy Adam, Professor, Study chair, Head of orthopedic and traumatology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462901
- Sponsor's protocol ID
- 17100365
- Status last verified
- Mar 2018
- First submitted
- 8 Dec 2017
- Last updated
- 13 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Select patients and do the surgery and follow up prognosis
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation of Displaced Midshaft Clavicular Fractures in Adults by Intramedullary Elastic Rod
- ClinicalTrials.gov ID
- NCT03462901
- Acronym / sponsor ID
- 17100365
- Conditions
- Clavicular Fracture
- Keywords
- Fixation of midshaft clavicular fracture by intramedullary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Oct 2016 (actual)
- Primary completion
- 20 Oct 2018 (estimated)
- Study completion
- 21 May 2019 (estimated)
- First posted
- 13 Mar 2018 (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.
Clavicular fracture, constitutes 2.6% e 5% of all adult fractures, most are located in the midshaft clavicle with different degrees of displacement. Conservative methods are commonly used for midshaft clavicular fractures treatment, but with various unsatisfactory complications such as nonunion, malunion and shoulders asymmetry. The rate of malunion after conservative treatment for the midshaft clavicular fractures reached 15%, and 30% patients were unsatisfied. Recently, early midshaft clavicular fractures could greatly reduce the incidence rate of nonunion and malunion. Open reduction and plate-screw fixation was considered as the gold standard with the advantages of firm fixation and earlier postoperative mobilization, but also with disadvantages of larger incision and more organizations being exposed, presenting with many postoperative complications. Intramedullary fixation treatment for mid-clavicular fractures has been favored due to its strengths including small incision, less periosteal striping, dispersion of stress and simple to operate However, early intra-medullary implants, such as Hagie pins and Kirschner wires, have been gradually replaced due to insufficient stability. In addition, various nails such as elastic stable intramedullar
Detailed description
Fixation of displaced midshaft clavicular fractures with minimally invasive technic as it helps for early mobilization to the shoulder and more safe, more cosmetically in comparison to other options.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fracture clavicle in adults
| Arm | Type | Receives |
|---|---|---|
| Elastic rod fixation | Experimental | Procedure: Percutaneous intramedullary fixation of displaced midshaft clavicular fractures .Percutaneous intramedullary fixation of displaced midshaft clavicular fractures |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Percutaneous intramedullary fixation of displaced midshaft clavicular fractures .Also: Intramedulary fixation of clavicular fracturesA group of 15 patients admitted to Assiut university with midshaft clavicular fractures treated by operative fixation of the fracture by single elastic rod through medial approach under image intensifier | Procedure or surgery | Elastic rod fixation |
Primary outcome
Union rate
Time frame: Six months
We will compares rat of union between fixation of clavicular fracture by intramedullary elastic rod and other methods of fixation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Individual participant dataSharing planned: Yes. Select patients and do the surgery and follow up prognosis
Related trials for Clavicular Fracture
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Fluoroscopic Endobutton in Clavicle Fractures and AC Dislocations
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Effectiveness of Superficial Cervical and Clavipectoral Block for Clavicle Surgery
Clavicle Fracture, Postoperative Pain
Enrolling by invitation
Cervical Plexus Versus Infiltration for Clavicular Operations (CERPICO)
Clavicle Surgery, Clavicle Fracture
Active, not recruiting
KT Tape for Pediatric Clavicle Fractures
Clavicle Fracture
Active, not recruitingObservational study
Descriptive Single-center Retrospective Study of a Series of Cases of Clavicle Pseudarthrosis: Epidemiology, Surgical Management, and Functional Outcomes
Pseudarthrosis, Clavicle Fracture
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.
Faisal Fahmy Adam, Professor study chair
Head of orthopedic and traumatology department
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous intramedullary fixation of displaced midshaft clavicular fractures . in people with Clavicular Fracture, 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?
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 13 Mar 2018. 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?
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?
Union rate (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2018.