Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-21 @ 8:40 AM
Study NCT ID:
NCT05897866
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2023-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D002062', 'term': 'Bursitis'}, {'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D000070896', 'term': 'Bankart Lesions'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D013708', 'term': 'Tendon Injuries'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D012784', 'term': 'Shoulder Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D009135', 'term': 'Muscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-23', 'studyFirstSubmitDate': '2023-05-12', 'studyFirstSubmitQcDate': '2023-06-01', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Less open surgery trauma', 'timeFrame': '25 minutes to 45 minutes,', 'description': 'Directly going to the goal lesion with less expansion'}], 'secondaryOutcomes': [{'measure': 'Smaller surgical incision than MLSA', 'timeFrame': 'Less than 5 cm', 'description': 'Directly going to the goal lesion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shoulder', 'Shoulder approach', 'Lateral Shoulder approach', 'Shoulder impingement syndrome', 'Rotator cuff tendinopathy', 'Adhesive capsulitis', 'Frozen shoulder syndrome', 'MLSA', 'Shoulder arthroscopy', 'Mini Lateral Shoulder Approach', "Second Sayed Issa's Approach", 'Hill-sachs lesion', 'mini-incision release', 'Tendinopathy', 'arthroscopy', 'tendon injuries'], 'conditions': ['Shoulder Impingement Syndrome', 'Adhesive Capsulitis', 'Rotator Cuff Tear', 'Hill-Sachs Lesion', 'Frozen Shoulder', 'Tendinopathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://asayedissa.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) is a limited lateral approach to the shoulder arthroscopically guided. Which achieves less surgical trauma and smaller surgical incision than even in Mini Lateral Shoulder Approach (MLSA).", 'detailedDescription': "After making a full clinical, X-rays and MRI examinations of the shoulder, and finding Shoulder Impingement Syndrome, Adhesive Capsulitis, Rotator Cuff Tear, or Hill-Sachs lesion, we decide to manage the problem surgically We can survey the shoulder from the inside and determine the shape, size and the exact position of the defect by shoulder arthroscopy.\n\nThe patient is operated on under general anesthesia; shoulder arthroscopy can be performed in the lateral decubitus or beach chair position which is the basic shoulder arthroscopy (Beach Chair Patient Positioning).\n\nAfter identifying the full characteristics of the lesion, we go for Mini Lateral Shoulder Approach (MLSA), as known as Second Sayed Issa's Approach."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presented with Shoulder Impingement Syndrome refractory to conservative treatment and local steroid injection\n* Patients presented with Adhesive Capsulitis and Frozen Shoulder Syndrome refractory to conservative treatment and local steroid injection\n* Patients without femur head immigration on X-ray\n* Patients with injury for one month to six months maximum\n\nExclusion Criteria:\n\n* Patients with femur head immigration on X-ray\n* Patients with injury for more than six months\n* Uncontrolled diabetes mellitus type 1 and 2\n* Patients with non controlled Vascular hypertension\n* Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.\n* Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization'}, 'identificationModule': {'nctId': 'NCT05897866', 'acronym': 'HLSSM', 'briefTitle': "Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM)", 'organization': {'class': 'INDIV', 'fullName': 'Issa, Abdulhamid Sayed, M.D.'}, 'officialTitle': "Sayed Issa's Hybrid Limited Shoulder Surgical Management (HLSSM)", 'orgStudyIdInfo': {'id': "Sayed Issa's HLSSM"}, 'secondaryIdInfos': [{'id': 'HLSSM', 'type': 'OTHER', 'domain': 'Dr. Abdulhamid Sayed Issa Clinic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Issa3', 'description': 'Dr.A.Sayed Issa and his team', 'interventionNames': ["Procedure: Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management"]}], 'interventions': [{'name': "Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management", 'type': 'PROCEDURE', 'otherNames': ["Sayed Issa's HSSM"], 'description': 'Using Arthroscopy and then Limited Opening by Mini Lateral Shoulder Approach (MLSA) for the shoulder surgery.', 'armGroupLabels': ['Issa3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aleppo', 'country': 'Syria', 'facility': 'Dr. Abdulhamid Sayed Issa Clinic', 'geoPoint': {'lat': 36.20124, 'lon': 37.16117}}]}, 'ipdSharingStatementModule': {'url': 'http://www.asayedissa.com', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Issa, Abdulhamid Sayed, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}