Glenoid; FractureNCT04070859
Fixation of Glenoid Fractures
An observational study of Glenoid; Fracture, run by Assiut University at 1 site in Egypt.
Trial summary
Scapula fractures are uncommon but make up 3-5% of all shoulder girdle injuries. Moreover, intraarticular glenoid fossa fractures represent only 1% of scapula fractures. They are frequently found with concomitant injuries to chest, head, brachial plexus and humerus. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Glenoid; Fracture
- What is being tested?
- Internal Fixation of Glenoid Fractures
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to Aug 2020
- 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 60 years
- All sexes
- Adult
Study population: ALl Healthy Young Adults e out comorbidities ( DM, uncontrolled HTN,...etc)
Who may be able to join
- 1-Fracture Pattern:
- All partial \& complete articular Glenoid Fractures: with Non congruent articular surface; >20° deviation in angle between the glenoid and lateral scapular rim compared to the anatomical angle.
- All Extra articular Glenoid fractures: with >20° deviation in angle between the glenoid and lateral scapular rim compared to the anatomical angle.
- All Extra articular Glenoid fractures e >20° difference In GPA compared to The GPA of the normal side.
- Fractures e an intra-articular gap or step-off of 4 to 10 mm or more.
- If glenohumeral instability is present after dislocation. 2-Age: skeletally mature patients (>18-60y)
Who cannot join
- 1- Fractures e an intra-articular gap or step-off < 4 mm. 2- Timing of surgery not more than 2 weeks from the initial trauma 3- Polytraumatized patients e ISS>14. 4- Associated Neurovascular Injury. 5- Open Fractures. 6- Associated comorbidities e.g. (Uncontrolled DM, Renal impairment).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Diaa Mohammad
Asyut, 71111
Diaa Mohammad, 1012392379, diaa89ortho@gmail.com
About this study
Official title: Evaluation of Internal Fixation Of Glenoid Fractures
Scapula fractures are uncommon but make up 3-5% of all shoulder girdle injuries. Moreover, intraarticular glenoid fossa fractures represent only 1% of scapula fractures.
They are frequently found with concomitant injuries to chest, head, brachial plexus and humerus.
Read more
The glenoid is an oval shaped portion on the lateral border of the scapula that articulates with the circular rounded end of the humeral head.
Superiorly the glenoid is part of the superior shoulder suspensory complex (SSSC) consisting of superior glenoid, coracoid process, coracoclavicular ligaments, distal end of the clavicle, acromioclavicular joint, coracoacromial ligament and acromial process.
Subsequently, stability of the shoulder is a complex mechanism in which muscles, ligamentous and capsular restraints, the labrum and joint vacuum, each play a role depending on position and activity.
The history of patients with glenoid fractures will mostly consist of either shoulder dislocation or direct trauma to the humeral head. The affected arm is "pseudo-paralysed" and supported in adduction and internal rotation.
Because of a thick layer of soft tissue, only mild swelling and ecchymosis may be seen .
For the diagnosis of scapular injuries X-rays are routinely taken , MSCT scanning , MRI \& Nerve conduction velocity may be done.
Main parameters defining operative treatment are instability, the articular surface fragment size and the degree of displacement. However, concomitant injuries (e.g. thorax, head, extremity fractures, plexus lesion), age, occupation, level of activity and dominance, play a key role in management.
- Conditions
- Glenoid; Fracture
- Being tested
- Internal Fixation of Glenoid Fractures
- Keywords
- internal fixation
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Fixation of Glenoid FracturesProcedure or surgery
Internal Fixation via (Paltes \& Screws, Tension bands. etc)
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the role of internal fixation of glenoid fracture in healthy adults by ASES score
regarding functional outcome at 6 months and 1 year.
Measured: Baseline
Secondary outcomes (1)
Asses Fracture Union, Range of Motion Asses functional outcome by DASH score Asses Fracture Union, Range of Motion Asses functional outcome by DASH score
regarding functional outcome at 6 months and 1 year.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Jul 2019
- Primary completionJul 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glenoid; 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diaa El-Din Mohamed, Assiut University
- Investigators
- Ali Mohamadean, Study director, Assiut UniversityGalal El-Din Zaki, Study chair, Assiut UniversityMahmoud Badran, Study director, Assiut UniversityDiaa El-Din Mohamed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070859
- Sponsor's protocol ID
- Glenoid Fractures Fixation
- Status last verified
- Aug 2019
- First submitted
- 21 Jul 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
2.6-References : 1. Lewis Gs, Armstrong AD. glenoid spherical orientation and version. J Shoulder Elbow Surg 2011 ; 20 : 3-11. 2. Rockwood C, Matsen FAI, Wirth M, lippitt S. the shoulder. in : saunders elsevier, Philadelphia, 2009 ; 4th ed. : 333-380. 3. Van noort A. scapular fractures. in : rockwood and green's Fractures in adults. (eds. Bucholz rW, CourtBrown Cm, Heckman JD, tornetta P). Wolters Kluwer, Philadelphia, 2010 ; 7th ed : 1144-1164. 4. Jeray Kj, Cole PA. Clavicle and scapula fracture problems : functional assessment and current treatment strategies. Instr Course Lect 2011 ; 60 : 51-71. 5. Van noort A. scapular fractures. in : rockwood and green's Fractures in adults. (eds. Bucholz rW, CourtBrown Cm, Heckman JD, tornetta P). Wolters Kluwer, Philadelphia, 2010 ; 7th ed : 1144-1164. 6. Voleti PB, Namdari S, Mehta S. Fractures of the scapula. Adv Orthop. 2012;2012:1-7. doi: 10.1155/2012/903850. 7. van Oostveen, D. P. H., Temmerman, O. P. P., Burger, B. J., van Noort, A. & Robinson, M. Glenoid fractures: a review of pathology, classification, treatment and results. Acta Orthop Belg 80, 88-98 (2014). 8. Zlowodzki M, Bhandari M, Zelle BA, Kregor PJ, Cole PA. Treatment of scapula fractures: systematic review of 520 fractures in 22 case series. J Orthop Trauma. 2006;20:230-233. doi: 10.1097/00005131-200603000-00013. 9. Jaeger M, et al. The AO Foundation and Orthopaedic trauma association (AO/OTA) scapula fracture classification system: focus on glenoid fossa involvement. J Shoulder Elb Surg. 2013;22:512-520. doi: 10.1016/j.jse.2012.08.003. 10. Audige L, Kellam JF, Lambert S, et al. The AO Foundation and Orthopedic Trauma Association (AO/OTA ) scapula fracture classification system: focus in body involvement. J Shoulder Elbow surg. 2014 Feb;23 (2) :189-196. 11. Harvey E, Audige L, Herscovici D, Jr, et al. Development and validation of the new international classification for scapula fractures. J Orthop Trauma. 2012 Jun;26 (6) : 364-369. 12. Jaeger M, Lambert S, Sudkamp NP, et al. The AO Foundation and Orthopedic Trauma Association (AO/OTA ) scapula fracture classification system: focus in body involvement. J Shoulder Elbow surg. 2013 Apr; 22 (4) :512-520. 13. Bahk Ms, Kuhn j e, Galatz lM, Connor pM, Williams Gr jr. acromioclavicular and sternoclavicular injuries and clavicular, glenoid, and scapular fractures. J Bone Joint Surg Am 2009 ; 91 : 2492-2510 14. Osti M, Gohm A, Benedetto Kp. results of open reconstruction of anterior glenoid rim fractures following shoulder dislocation. Arch Orthop Trauma Surg 2009 ; 129 : 1245-1249. 15. Peter Cole, Steven R. Fractures of the Clavicle, Scapula, and Glenoid .AAOS .2014; 28:6-7.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Internal Fixation Of Glenoid Fractures
- ClinicalTrials.gov ID
- NCT04070859
- Acronym / sponsor ID
- Glenoid Fractures Fixation
- Conditions
- Glenoid; Fracture
- Keywords
- internal fixation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 28 Aug 2019 (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.
Scapula fractures are uncommon but make up 3-5% of all shoulder girdle injuries. Moreover, intraarticular glenoid fossa fractures represent only 1% of scapula fractures.
They are frequently found with concomitant injuries to chest, head, brachial plexus and humerus.
The glenoid is an oval shaped portion on the lateral border of the scapula that articulates with the circular rounded end of the humeral head.
Superiorly the glenoid is part of the superior shoulder suspensory complex (SSSC) consisting of superior glenoid, coracoid process, coracoclavicular ligaments, distal end of the clavicle, acromioclavicular joint, coracoacromial ligament and acromial process.
Subsequently, stability of the shoulder is a complex mechanism in which muscles, ligamentous and capsular restraints, the labrum and joint vacuum, each play a role depending on position and activity.
The history of patients with glenoid fractures will mostly consist of either shoulder dislocation or direct trauma to the humeral head. The affected arm is "pseudo-paralysed" and supported in adduction and internal rotation.
Because of a thick layer of soft tissue, only mild swelling and ecchymosis may be seen .
For the diagnosis of scapular injuries X-rays are routinely taken , MSCT scanning , MRI \& Nerve conduction velocity may be done.
Main parameters defining operative treatment are instability, the articular surface fragment size and the degree of displacement. However, concomitant injuries (e.g. thorax, head, extremity fractures, plexus lesion), age, occupation, level of activity and dominance, play a key role in management.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- ALl Healthy Young Adults e out comorbidities ( DM, uncontrolled HTN,...etc)
Key inclusion criteria (6 listed)
- 1-Fracture Pattern:
Key exclusion criteria (1 listed)
- 1- Fractures e an intra-articular gap or step-off < 4 mm. 2- Timing of surgery not more than 2 weeks from the initial trauma 3- Polytraumatized patients e ISS>14. 4- Associated Neurovascular Injury. 5- Open Fractures. 6- Associated comorbidities e.g. (Uncontrolled DM, Renal impairment).
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 |
|---|---|---|
| Internal Fixation of Glenoid FracturesInternal Fixation via (Paltes \& Screws, Tension bands. etc) | Procedure or surgery | – |
Primary outcome
Evaluate the role of internal fixation of glenoid fracture in healthy adults by ASES score
Time frame: Baseline
regarding functional outcome at 6 months and 1 year.
1 secondary outcome
Asses Fracture Union, Range of Motion Asses functional outcome by DASH score Asses Fracture Union, Range of Motion Asses functional outcome by DASH score
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background2.6-References : 1. Lewis Gs, Armstrong AD. glenoid spherical orientation and version. J Shoulder Elbow Surg 2011 ; 20 : 3-11. 2. Rockwood C, Matsen FAI, Wirth M, lippitt S. the shoulder. in : saunders elsevier, Philadelphia, 2009 ; 4th ed. : 333-380. 3. Van noort A. scapular fractures. in : rockwood and green's Fractures in adults. (eds. Bucholz rW, CourtBrown Cm, Heckman JD, tornetta P). Wolters Kluwer, Philadelphia, 2010 ; 7th ed : 1144-1164. 4. Jeray Kj, Cole PA. Clavicle and scapula fracture problems : functional assessment and current treatment strategies. Instr Course Lect 2011 ; 60 : 51-71. 5. Van noort A. scapular fractures. in : rockwood and green's Fractures in adults. (eds. Bucholz rW, CourtBrown Cm, Heckman JD, tornetta P). Wolters Kluwer, Philadelphia, 2010 ; 7th ed : 1144-1164. 6. Voleti PB, Namdari S, Mehta S. Fractures of the scapula. Adv Orthop. 2012;2012:1-7. doi: 10.1155/2012/903850. 7. van Oostveen, D. P. H., Temmerman, O. P. P., Burger, B. J., van Noort, A. & Robinson, M. Glenoid fractures: a review of pathology, classification, treatment and results. Acta Orthop Belg 80, 88-98 (2014). 8. Zlowodzki M, Bhandari M, Zelle BA, Kregor PJ, Cole PA. Treatment of scapula fractures: systematic review of 520 fractures in 22 case series. J Orthop Trauma. 2006;20:230-233. doi: 10.1097/00005131-200603000-00013. 9. Jaeger M, et al. The AO Foundation and Orthopaedic trauma association (AO/OTA) scapula fracture classification system: focus on glenoid fossa involvement. J Shoulder Elb Surg. 2013;22:512-520. doi: 10.1016/j.jse.2012.08.003. 10. Audige L, Kellam JF, Lambert S, et al. The AO Foundation and Orthopedic Trauma Association (AO/OTA ) scapula fracture classification system: focus in body involvement. J Shoulder Elbow surg. 2014 Feb;23 (2) :189-196. 11. Harvey E, Audige L, Herscovici D, Jr, et al. Development and validation of the new international classification for scapula fractures. J Orthop Trauma. 2012 Jun;26 (6) : 364-369. 12. Jaeger M, Lambert S, Sudkamp NP, et al. The AO Foundation and Orthopedic Trauma Association (AO/OTA ) scapula fracture classification system: focus in body involvement. J Shoulder Elbow surg. 2013 Apr; 22 (4) :512-520. 13. Bahk Ms, Kuhn j e, Galatz lM, Connor pM, Williams Gr jr. acromioclavicular and sternoclavicular injuries and clavicular, glenoid, and scapular fractures. J Bone Joint Surg Am 2009 ; 91 : 2492-2510 14. Osti M, Gohm A, Benedetto Kp. results of open reconstruction of anterior glenoid rim fractures following shoulder dislocation. Arch Orthop Trauma Surg 2009 ; 129 : 1245-1249. 15. Peter Cole, Steven R. Fractures of the Clavicle, Scapula, and Glenoid .AAOS .2014; 28:6-7.
Related trials for Glenoid; Fracture
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
Active, not recruitingObservational study
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
Rotator Cuff Tears, Rheumatoid Arthritis Shoulder
Recruiting
Zimmer Biomet Shoulder Arthroplasty PMCF
Shoulder Fractures, Shoulder Arthritis
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.
Ali Mohamadean study director
Assiut University
Galal El-Din Zaki study chair
Assiut University
Mahmoud Badran study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glenoid; Fracture, run by Assiut University at 1 site in Egypt.
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 6 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Diaa El-Din Mohammad (+201012392379, diaa89ortho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the role of internal fixation of glenoid fracture in healthy adults by ASES score (time frame: Baseline). 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 NCT04070859, which also lists 1 linked publication.
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 28 Aug 2019.