- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04070859
Fixation of Glenoid Fractures
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Assiut, Egypt, 71111
- Recruiting
- Diaa Mohammad
-
Contact:
- Diaa Mohammad
- Phone Number: 1012392379
- Email: diaa89ortho@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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)
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
regarding functional outcome at 6 months and 1 year.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ali Mohamadean, Assiut University
- Study Chair: Galal El-Din Zaki, Assiut University
- Study Director: Mahmoud Badran, Assiut University
- Principal Investigator: Diaa El-Din Mohamed, Assiut University
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Glenoid Fractures Fixation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glenoid; Fracture
-
Boston Medical CenterCompletedScapula Fracture | Glenoid; FractureUnited States, Canada
-
Peking University Third HospitalRecruiting
-
Meir Medical CenterUnknownSubchondral Fractures of the Glenoid
-
University Hospital, Strasbourg, FranceUnknown
-
Sohag UniversityCompleted
-
Andrews Research & Education FoundationWithdrawn
-
Henry Ford Health SystemWithdrawnLabral Tear, GlenoidUnited States
-
Knoxville Orthopedic ClinicUnknownThe Primary Disease Process Being Studied is Shoulder OA and the Effect of an All Polyethelene Glenoid Component on Shoulder ArthroplastyUnited States
-
MaterialiseEnrolling by invitationOsteoarthritis of the Shoulder | Arthroplasty, Replacement, Shoulder | Glenoid CavityBelgium, Netherlands
Clinical Trials on Internal Fixation of Glenoid Fractures
-
The First Hospital of Hebei Medical UniversityCompleted
-
Samer youssef mansour meglaaAssiut UniversityActive, not recruiting
-
Boston Medical CenterCompletedScapula Fracture | Glenoid; FractureUnited States, Canada
-
Assiut UniversityUnknown
-
Mansoura UniversityCompletedGreater Tuberosity FracturesEgypt
-
Mohamed Gamal ThabetCompletedAssessment of Proper Union of FracturesEgypt
-
Sohag Universitysohag university hospitalRecruitingTibial Plateau Fractures Schatzker Type IIEgypt
-
Haukeland University HospitalUllevaal University Hospital; Ostfold Hospital Trust; Helse Stavanger HF; St. Olavs... and other collaboratorsRecruitingAnkle Fractures | Treatment Outcome | Syndesmotic Injuries | Patient Reported Outcome Measure | Posterior Malleolus FracturesNorway
-
Qinghai UniversityCompleted