Post-Traumatic Orbital DeformityNCT03683615
Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures
A study testing repair of orbital floor fractures using resorbable plates in people with Post-Traumatic Orbital Deformity, run by Minia University.
Trial summary
It is a prospective study to evaluate the use of resorbable plates for the repair of blow out orbital floor fractures over a follow up period of one year at both cosmetic and functional levels. Read more about this study
- Who is it for?
- Ages 10 to 50 years
- Conditions the study is for
- Post-Traumatic Orbital Deformity
- What is being tested?
- repair of orbital floor fractures using resorbable plates
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Apr 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 10 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Class I, II blowout floor fracture.
- Presented within 2 weeks of trauma.
- Have muscle or soft tissue distortion with clinically significant diplopia, enophthalmos or restrictive strabismus.
Who cannot join
- Comminuted orbital fractures involving the rim.
- Associated globe injuries.
- Delayed presentation.
About this study
It is a prospective study to evaluate the use of resorbable plates for the repair of blow out orbital floor fractures over a follow up period of one year at both cosmetic and functional levels.
- Conditions
- Post-Traumatic Orbital Deformity
- Being tested
- repair of orbital floor fractures using resorbable plates
- Keywords
- Resorbable, blow out fractures
- Medical subject headings
- Orbital Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repair of orbital floor fractures using resorbable platesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| patients with traumatic recent orbital blow out fractures | Other | Not described Receives: Procedure: repair of orbital floor fractures using resorbable plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
anatomical reduction of the fracture
reduction of the fractured segment and restore the normal orbital volume and contents . assessment of reduction by measuring the changes in the orbital volume using computed tomography
Measured: one month
Secondary outcomes (1)
improvement of symptoms
improvement of the patient complaints as diplopia and enophthalmos using questionnaire
Measured: 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study startJul 2016
- Primary completionJan 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Orbital DeformityStudies of the same condition, open and under way.
- More trials run by Minia 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Tamer Ismail Gawdat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683615
- Sponsor's protocol ID
- 16111985
- Status last verified
- Sep 2018
- First submitted
- 20 Sep 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures
- ClinicalTrials.gov ID
- NCT03683615
- Acronym / sponsor ID
- 16111985
- Conditions
- Post-Traumatic Orbital Deformity
- Keywords
- Resorbable, blow out fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 25 Sep 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.
It is a prospective study to evaluate the use of resorbable plates for the repair of blow out orbital floor fractures over a follow up period of one year at both cosmetic and functional levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with traumatic recent orbital blow out fractures | Other | Procedure: repair of orbital floor fractures using resorbable plates |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Class I, II blowout floor fracture.
- Presented within 2 weeks of trauma.
- Have muscle or soft tissue distortion with clinically significant diplopia, enophthalmos or restrictive strabismus.
Key exclusion criteria (3 listed)
- Comminuted orbital fractures involving the rim.
- Associated globe injuries.
- Delayed presentation.
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 |
|---|---|---|
| repair of orbital floor fractures using resorbable plates | Procedure or surgery | patients with traumatic recent orbital blow out fractures |
Primary outcome
anatomical reduction of the fracture
Time frame: one month
reduction of the fractured segment and restore the normal orbital volume and contents . assessment of reduction by measuring the changes in the orbital volume using computed tomography
1 secondary outcome
improvement of symptoms
Time frame: 6 to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing repair of orbital floor fractures using resorbable plates in people with Post-Traumatic Orbital Deformity, run by Minia 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 3 inclusion and 3 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 25 Sep 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?
anatomical reduction of the fracture (time frame: one month). 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 25 Sep 2018.