Multiple Fractures of RibsNCT05975762
Outcome of Surgical Fixation of Multiple Fractured Ribs at Sohag University Hospital
A study testing surgical rib fixation in people with Multiple Fractures of Ribs, run by Sohag University.
Trial summary
The ribs are rigid and flexible structures that make up the chest skeleton and are a set of twelve paired bones. After Blunt trauma rib fractures incidence is about 30 to 40% [1]. Due to trauma, (4th -9th) ribs are often affected and the fracture point of the ribs is often on the midaxillary line. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Fractures of Ribs
- What is being tested?
- surgical rib fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- multiple fractured ribs pre ventilation
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
Ayman Abd Al-gafar, professor contact
About this study
The ribs are rigid and flexible structures that make up the chest skeleton and are a set of twelve paired bones. After Blunt trauma rib fractures incidence is about 30 to 40% [1].
Due to trauma, (4th -9th) ribs are often affected and the fracture point of the ribs is often on the midaxillary line. In ( 1st\&2nd) ribs fractures subclavian vessels and brachial plexus damage may occur. In fractures in the lower ribs (8th-12th ribs), intra-abdominal organs injury such as liver, spleen and kidney should be investigated. 11-12. ribs fractures are rare because the ribs are more flexible (floating).
Pain is the most important symptom indicating rib fracture, and it usually increases with coughing, breathing, and movement. Broken rib ends can be felt with palpation with sever tenderness at the site of fracture. Pneumothorax and/or hemothorax may develop as a result of the sharp end of the broken rib causing lung parenchymal damage[2].
- Conditions
- Multiple Fractures of Ribs
- Being tested
- surgical rib fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical rib fixationProcedure or surgery
Also called open reduction and internal fixation
open reduction and internal rib fixation
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | surgical fixation group Receives: Procedure: surgical rib fixation |
| control group | No intervention | conservation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
mechanical ventilation
the need and duration of mechanical ventilation
Measured: 1 year
thoracic pain
measure severity of pain using pain scale 0 to10.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple Fractures of RibsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Hassan Sayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975762
- Sponsor's protocol ID
- Soh-Med-23-07-09MS
- Status last verified
- Aug 2023
- First submitted
- 24 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marasco SF, Martin K, Niggemeyer L, Summerhayes R, Fitzgerald M, Bailey M. Impact of rib fixation on quality of life after major trauma with multiple rib fractures. Injury. 2019 Jan;50(1):119-124. doi: 10.1016/j.injury.2018.11.005. Epub 2018 Nov 3.
PubMed 30442372Schuurmans J, Goslings JC, Schepers T. Operative management versus non-operative management of rib fractures in flail chest injuries: a systematic review. Eur J Trauma Emerg Surg. 2017 Apr;43(2):163-168. doi: 10.1007/s00068-016-0721-2. Epub 2016 Aug 29.
PubMed 27572897Beks RB, Peek J, de Jong MB, Wessem KJP, Oner CF, Hietbrink F, Leenen LPH, Groenwold RHH, Houwert RM. Fixation of flail chest or multiple rib fractures: current evidence and how to proceed. A systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2019 Aug;45(4):631-644. doi: 10.1007/s00068-018-1020-x. Epub 2018 Oct 1.
PubMed 30276722
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Surgical Fixation of Multiple Fractured Ribs at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05975762
- Acronym / sponsor ID
- Soh-Med-23-07-09MS
- Conditions
- Multiple Fractures of Ribs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 4 Aug 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 ribs are rigid and flexible structures that make up the chest skeleton and are a set of twelve paired bones. After Blunt trauma rib fractures incidence is about 30 to 40% [1].
Due to trauma, (4th -9th) ribs are often affected and the fracture point of the ribs is often on the midaxillary line. In ( 1st\&2nd) ribs fractures subclavian vessels and brachial plexus damage may occur. In fractures in the lower ribs (8th-12th ribs), intra-abdominal organs injury such as liver, spleen and kidney should be investigated. 11-12. ribs fractures are rare because the ribs are more flexible (floating).
Pain is the most important symptom indicating rib fracture, and it usually increases with coughing, breathing, and movement. Broken rib ends can be felt with palpation with sever tenderness at the site of fracture. Pneumothorax and/or hemothorax may develop as a result of the sharp end of the broken rib causing lung parenchymal damage[2].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Procedure: surgical rib fixationsurgical fixation group |
| control group | No intervention | –conservation group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- multiple fractured ribs pre ventilation
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| surgical rib fixationAlso: open reduction and internal fixationopen reduction and internal rib fixation | Procedure or surgery | intervention group |
Primary outcome
mechanical ventilation
Time frame: 1 year
the need and duration of mechanical ventilation
thoracic pain
Time frame: 1 year
measure severity of pain using pain scale 0 to10.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Background: PubMed 30442372Marasco SF, Martin K, Niggemeyer L, Summerhayes R, Fitzgerald M, Bailey M. Impact of rib fixation on quality of life after major trauma with multiple rib fractures. Injury. 2019 Jan;50(1):119-124. doi: 10.1016/j.injury.2018.11.005. Epub 2018 Nov 3.
- Background: PubMed 27572897Schuurmans J, Goslings JC, Schepers T. Operative management versus non-operative management of rib fractures in flail chest injuries: a systematic review. Eur J Trauma Emerg Surg. 2017 Apr;43(2):163-168. doi: 10.1007/s00068-016-0721-2. Epub 2016 Aug 29.
- Background: PubMed 30276722Beks RB, Peek J, de Jong MB, Wessem KJP, Oner CF, Hietbrink F, Leenen LPH, Groenwold RHH, Houwert RM. Fixation of flail chest or multiple rib fractures: current evidence and how to proceed. A systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2019 Aug;45(4):631-644. doi: 10.1007/s00068-018-1020-x. Epub 2018 Oct 1.
- Individual participant dataSharing planned: Undecided
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.
Ayman Abd Al-gafar, professor contact
Questions about this trial
What is this clinical trial studying?
A study testing surgical rib fixation in people with Multiple Fractures of Ribs, run by Sohag 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 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 4 Aug 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 Hossam Hassan, resident (01147502309, hossamhassan@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mechanical ventilation (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT05975762, which also lists 3 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 4 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.