Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-27 @ 10:44 PM
Study NCT ID:
NCT05279261
Status:
UNKNOWN
Last Update Posted:
2022-03-15
First Post:
2021-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effect of the Axillary Approach to 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2022-03-14', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fracture union', 'timeFrame': '6 months', 'description': 'X-rays and CT scans are used to evaluate the bone union'}, {'measure': 'the Constant and Murley scores', 'timeFrame': '2 years', 'description': 'The questionaire evaluates shoulder function in terms of pain (15 points), daily activities (20 points), range of motion (40 points) and muscle strength (25 points) on a scale of 100, with the higher the score, the better the function.'}, {'measure': 'the DASH(disabilities of the arm，shoulder and hand) scores', 'timeFrame': '2 years', 'description': "Shoulder function was evaluated by patients' subjective feelings about pain, activity, daily life, work and entertainment of the affected limb in the past 1 week. A total of 30 items were evaluated, and the score of each item was 1-5, DASH= (total score-30) /1.2, with the maximum score of 100, the lower the score, the better the function"}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '2 years', 'description': 'The presence of postoperative complications,including implant failure, osteolysis, and soft-tissue reactions, are determined by symptoms and images.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fracture; Glenoid']}, 'descriptionModule': {'briefSummary': 'Glenoid fractures result in glenohumeral post-trauma arthritis and instability. Operative treatment is indicated for severe fractures. The traditional deltopectoral approach, which requires detachment of the subscapularis, has many drawbacks, including loss of external rotation and suboptimal fixation. Arthroscopic techniques also cannot allow anatomic reduction and biomechanical stability for large fractures. We describe an alternative approach that enters from the axilla through the interval between the rotator cuff and the inferior glenoid, neck and lateral border of the scapula without detachment of the rotator cuff.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Traumatic and closed fractures\n* Fracture type conforms to Ideberg Ia classification or AO/OTA F1.1 classification\n* Fracture displacement ≥4mm, the area of involvement ≥20%.\n\nExclusion Criteria:\n\n* Severe multiple trauma\n* Pathological fracture\n* Unable to tolerate surgical treatment\n* The interval between injury and operation was \\> 2 weeks'}, 'identificationModule': {'nctId': 'NCT05279261', 'briefTitle': 'Clinical Effect of the Axillary Approach to Glenoid Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Clinical Effect of the Axillary Approach to Acute Anterior Glenoid Fractures', 'orgStudyIdInfo': {'id': 'IRB00006761-M2019363'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Undergo the axillary approach', 'interventionNames': ['Procedure: The axillary approach']}], 'interventions': [{'name': 'The axillary approach', 'type': 'PROCEDURE', 'description': 'The approach enters from the axilla through the interval between the latissimus dorsi and subscapularis to expose the anteroinferior glenoid, neck and lateral border of the scapula with entire rotator cuff sparing and fix the fracture with screws or plates.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100083', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yun Tian, M.D', 'role': 'CONTACT', 'email': 'tiany@bjmu.edu.cn', 'phone': '+8613701053505'}], 'facility': 'Peking University Third Hospita', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yun Tian, M.D', 'role': 'CONTACT', 'email': 'tiany@bjmu.edu.cn', 'phone': '+86 13701053505'}, {'name': 'Yong Xing', 'role': 'CONTACT', 'email': 'xingyong@bjmu.edu.cn', 'phone': '+8618826227164'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}