Scapular FractureNCT05982327
Operative Management of Scapular Fractures
An observational study of Scapular Fracture, run by Assiut University.
Trial summary
Assessment of functional outcome of operative management of scapular fractures through Arabic version DASH score Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scapular Fracture
- What is being tested?
- ORIF
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2024to Mar 2025
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Any patients who meets the inclusion criteria and agrees to be involved in our study will do: 1. Preoperative assessment: 1. Examination : Neurological and Vascular examination 2. Imaging: * Plain X- ray (True AP - Scapula Y view ) and Plain X-ray (True AP )of contralateral side Measurement of Glenopolar angle (GPA) * CT scan 2. Intra-operative assessment: a. Selection of approach. b.Postion C.Type of osteosynthesis d. Blood loss e. Radiation exposure.
Who may be able to join
- 1.All patient presented with scapular fractures more than 18 years old involving body, neck and glenoid 2.Intraarticular glenoid fractures with step-off >4 mm 3.>20% of the joint is involved and Fragment large enough to be hold by lag screw.
Who cannot join
- 1- Low demanded patients:Age >65 yrs . 2.Scapular fractures of acromion and coracoid process and Osteoporotic fractures .
- 3.Scapular fractures associated with brain injuries cervical spine injuries and brachial plexus injuries.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Operative Management of Scapular Fractures in Level 1 Trauma Center
Assessment of functional outcome of operative management of scapular fractures through Arabic version DASH score
Read the detailed description
Scapular fractures are rare, accounting less than1% all fractures. 3-5%all fractures of shoulder girdle, however very serious because 80-90% due to high energy trauma such as Motor car accidents or Fall from height. It can be associated with life-threatening injuries such as thoraco-scapular dissociation and vascular injury as subclavian and axillary vessels and brachial plexus injuries.So morbidity and mortality reports are relatively high.It can be diagnosed by X ray and computed tomography scan (CT scan) that play important role to discover scapular fractures and associated injuries ,and to guide clinical decision such as approaches and other surgical interventions.Most of scapular fractures are managed conservatively by Immbolization in sling .literature stated that conservative management of scapular body fractures and scapular neck fractures displaced less than 10 mm have satisfactory outcome and operative management suitable for displaced glenoid fossa fractures and scapular neck fractures more than 10 mm and associated with better functional outcome.Others stated that conservative management with highly displaced scapular body and neck fractures are associated with satisfactory long -term functional outcome with minor loss of motion and strength.
So standard treatment of scapular fracture is still controversial and there is no clear guidelines about management of scapular fractures.
In Investigators hypothesis, Operative management of scapular fractures is better choice due to better functional outcome, early rehabilitation ,high union rate and less complications. Investigators will try to answer this question ''What is the effect of operative management of scapular fractures on functional outcome?''
- Conditions
- Scapular Fracture
- Being tested
- ORIF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIFProcedure or surgery
fixation of scapular fractures by plate and screws
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of functional outcome
Arabic version DASH score
Measured: 6 week
Secondary outcomes (3)
Range of motion
Goniometer
Measured: Six months
Strength of shoulder muscle
Handheld dynamometer
Measured: Six months
Union rate
X ray-CT
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 posted8 Aug 2023
- Study start5 Apr 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Scapular 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
- 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, Ahmed Elbadry Mahmoud Ahmed, Assiut University
- Investigators
- Ahmed Elbadry Mahmoud, Resident, Principal investigator, Assiut UniversityAly Mohamadean, Prof Dr, Study director, Assiut UniversityMahmoud Badran, Ass.prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982327
- Sponsor's protocol ID
- Scapular fractures
- Status last verified
- Mar 2024
- First submitted
- 19 Jul 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ideberg R, Grevsten S, Larsson S. Epidemiology of scapular fractures. Incidence and classification of 338 fractures. Acta Orthop Scand. 1995 Oct;66(5):395-7. doi: 10.3109/17453679508995571.
PubMed 7484114Voleti PB, Namdari S, Mehta S. Fractures of the scapula. Adv Orthop. 2012;2012:903850. doi: 10.1155/2012/903850. Epub 2012 Nov 20.
PubMed 23209916McGahan JP, Rab GT, Dublin A. Fractures of the scapula. J Trauma. 1980 Oct;20(10):880-3. doi: 10.1097/00005373-198010000-00011.
PubMed 6252325Zelle BA, Pape HC, Gerich TG, Garapati R, Ceylan B, Krettek C. Functional outcome following scapulothoracic dissociation. J Bone Joint Surg Am. 2004 Jan;86(1):2-8. doi: 10.2106/00004623-200401000-00002.
PubMed 14711938Brown CV, Velmahos G, Wang D, Kennedy S, Demetriades D, Rhee P. Association of scapular fractures and blunt thoracic aortic injury: fact or fiction? Am Surg. 2005 Jan;71(1):54-7.
PubMed 15757058Lantry JM, Roberts CS, Giannoudis PV. Operative treatment of scapular fractures: a systematic review. Injury. 2008 Mar;39(3):271-83. doi: 10.1016/j.injury.2007.06.018. Epub 2007 Oct 4.
PubMed 17919636Kannan S, Singh HP, Pandey R. A systematic review of management of scapular fractures. Acta Orthop Belg. 2018 Dec;84(4):497-508.
PubMed 30879456Mayo KA, Benirschke SK, Mast JW. Displaced fractures of the glenoid fossa. Results of open reduction and internal fixation. Clin Orthop Relat Res. 1998 Feb;(347):122-30.
PubMed 9520882
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Operative Management of Scapular Fractures in Level 1 Trauma Center
- ClinicalTrials.gov ID
- NCT05982327
- Acronym / sponsor ID
- Scapular fractures
- Conditions
- Scapular Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Apr 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 8 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.
Assessment of functional outcome of operative management of scapular fractures through Arabic version DASH score
Detailed description
Scapular fractures are rare, accounting less than1% all fractures. 3-5%all fractures of shoulder girdle, however very serious because 80-90% due to high energy trauma such as Motor car accidents or Fall from height. It can be associated with life-threatening injuries such as thoraco-scapular dissociation and vascular injury as subclavian and axillary vessels and brachial plexus injuries.So morbidity and mortality reports are relatively high.It can be diagnosed by X ray and computed tomography scan (CT scan) that play important role to discover scapular fractures and associated injuries ,and to guide clinical decision such as approaches and other surgical interventions.Most of scapular fractures are managed conservatively by Immbolization in sling .literature stated that conservative management of scapular body fractures and scapular neck fractures displaced less than 10 mm have satisfactory outcome and operative management suitable for displaced glenoid fossa fractures and scapular neck fractures more than 10 mm and associated with better functional outcome.Others stated that conservative management with highly displaced scapular body and neck fractures are associated with satisfactory long -term functional outcome with minor loss of motion and strength.
So standard treatment of scapular fracture is still controversial and there is no clear guidelines about management of scapular fractures.
In Investigators hypothesis, Operative management of scapular fractures is better choice due to better functional outcome, early rehabilitation ,high union rate and less complications. Investigators will try to answer this question ''What is the effect of operative management of scapular fractures on functional outcome?''
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any patients who meets the inclusion criteria and agrees to be involved in our study will do: 1. Preoperative assessment: 1. Examination : Neurological and Vascular examination 2. Imaging: * Plain X- ray (True AP - Scapula Y view ) and Plain X-ray (True AP )of contralateral side Measurement of Glenopolar angle (GPA) * CT scan 2. Intra-operative assessment: a. Selection of approach. b.Postion C.Type of osteosynthesis d. Blood loss e. Radiation exposure.
Key inclusion criteria (1 listed)
- 1.All patient presented with scapular fractures more than 18 years old involving body, neck and glenoid 2.Intraarticular glenoid fractures with step-off >4 mm 3.>20% of the joint is involved and Fragment large enough to be hold by lag screw.
Key exclusion criteria (2 listed)
- 1- Low demanded patients:Age >65 yrs . 2.Scapular fractures of acromion and coracoid process and Osteoporotic fractures .
- 3.Scapular fractures associated with brain injuries cervical spine injuries and brachial plexus injuries.
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 |
|---|---|---|
| ORIFfixation of scapular fractures by plate and screws | Procedure or surgery | – |
Primary outcome
Assessment of functional outcome
Time frame: 6 week
Arabic version DASH score
3 secondary outcomes
Range of motion
Time frame: Six months
Strength of shoulder muscle
Time frame: Six months
Union rate
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Results publication: PubMed 7484114Ideberg R, Grevsten S, Larsson S. Epidemiology of scapular fractures. Incidence and classification of 338 fractures. Acta Orthop Scand. 1995 Oct;66(5):395-7. doi: 10.3109/17453679508995571.
- Results publication: PubMed 23209916Voleti PB, Namdari S, Mehta S. Fractures of the scapula. Adv Orthop. 2012;2012:903850. doi: 10.1155/2012/903850. Epub 2012 Nov 20.
- Results publication: PubMed 6252325McGahan JP, Rab GT, Dublin A. Fractures of the scapula. J Trauma. 1980 Oct;20(10):880-3. doi: 10.1097/00005373-198010000-00011.
- Results publication: PubMed 14711938Zelle BA, Pape HC, Gerich TG, Garapati R, Ceylan B, Krettek C. Functional outcome following scapulothoracic dissociation. J Bone Joint Surg Am. 2004 Jan;86(1):2-8. doi: 10.2106/00004623-200401000-00002.
- Results publication: PubMed 15757058Brown CV, Velmahos G, Wang D, Kennedy S, Demetriades D, Rhee P. Association of scapular fractures and blunt thoracic aortic injury: fact or fiction? Am Surg. 2005 Jan;71(1):54-7.
- Results publication: PubMed 17919636Lantry JM, Roberts CS, Giannoudis PV. Operative treatment of scapular fractures: a systematic review. Injury. 2008 Mar;39(3):271-83. doi: 10.1016/j.injury.2007.06.018. Epub 2007 Oct 4.
- Results publication: PubMed 30879456Kannan S, Singh HP, Pandey R. A systematic review of management of scapular fractures. Acta Orthop Belg. 2018 Dec;84(4):497-508.
- Results publication: PubMed 9520882Mayo KA, Benirschke SK, Mast JW. Displaced fractures of the glenoid fossa. Results of open reduction and internal fixation. Clin Orthop Relat Res. 1998 Feb;(347):122-30.
- Individual participant dataSharing planned: No
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.
Ahmed Elbadry Mahmoud, Resident principal investigator
Assiut University
Aly Mohamadean, Prof Dr study director
Assiut University
Mahmoud Badran, Ass.prof study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Scapular 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?
The sponsor lists 1 inclusion and 2 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 26 Mar 2024. 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 Ahmed Elbadry Mahmoud, Resident (+201551176565, ahmedelbadry@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of functional outcome (time frame: 6 week). 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 NCT05982327, which also lists 8 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 26 Mar 2024.