Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-01-16 @ 8:38 AM
Study NCT ID:
NCT04070859
Status:
UNKNOWN
Last Update Posted:
2019-08-28
First Post:
2019-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fixation of Glenoid Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-25', 'studyFirstSubmitDate': '2019-07-21', 'studyFirstSubmitQcDate': '2019-08-25', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the role of internal fixation of glenoid fracture in healthy adults by ASES score', 'timeFrame': 'Baseline', 'description': 'regarding functional outcome at 6 months and 1 year.'}], 'secondaryOutcomes': [{'measure': 'Asses Fracture Union, Range of Motion Asses functional outcome by DASH score Asses Fracture Union, Range of Motion Asses functional outcome by DASH score', 'timeFrame': 'Baseline', 'description': 'regarding functional outcome at 6 months and 1 year.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['internal fixation'], 'conditions': ['Glenoid; Fracture']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.\n\nThey are frequently found with concomitant injuries to chest, head, brachial plexus and humerus.\n\nThe glenoid is an oval shaped portion on the lateral border of the scapula that articulates with the circular rounded end of the humeral head.\n\nSuperiorly 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.\n\nSubsequently, 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.\n\nThe 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.\n\nBecause of a thick layer of soft tissue, only mild swelling and ecchymosis may be seen .\n\nFor the diagnosis of scapular injuries X-rays are routinely taken , MSCT scanning , MRI \\& Nerve conduction velocity may be done.\n\nMain 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ALl Healthy Young Adults e out comorbidities ( DM, uncontrolled HTN,...etc)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1-Fracture Pattern:\n\n 1. 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.\n 2. All Extra articular Glenoid fractures: with \\>20° deviation in angle between the glenoid and lateral scapular rim compared to the anatomical angle.\n 3. All Extra articular Glenoid fractures e \\>20° difference In GPA compared to The GPA of the normal side.\n 4. Fractures e an intra-articular gap or step-off of 4 to 10 mm or more.\n 5. If glenohumeral instability is present after dislocation. 2-Age: skeletally mature patients (\\>18-60y)\n\nExclusion Criteria:\n\n* 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).'}, 'identificationModule': {'nctId': 'NCT04070859', 'briefTitle': 'Fixation of Glenoid Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluation of Internal Fixation Of Glenoid Fractures', 'orgStudyIdInfo': {'id': 'Glenoid Fractures Fixation'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Internal Fixation of Glenoid Fractures', 'type': 'PROCEDURE', 'description': 'Internal Fixation via (Paltes \\& Screws, Tension bands. etc)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': '\u202aDiaa Mohammad\u202c', 'role': 'CONTACT', 'email': 'diaa89ortho@gmail.com', 'phone': '1012392379'}], 'facility': '\u202aDiaa Mohammad\u202c', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': '\u202aDiaa El-Din Mohammad\u202c', 'role': 'CONTACT', 'email': 'diaa89ortho@gmail.com', 'phone': '+201012392379'}], 'overallOfficials': [{'name': 'Ali Mohamadean', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Galal El-Din Zaki', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}, {'name': 'Mahmoud Badran', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Diaa El-Din Mohamed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Diaa El-Din Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}