Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT04766905
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2021-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mini Lateral Shoulder Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D002062', 'term': 'Bursitis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'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': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-19', 'studyFirstSubmitDate': '2021-02-12', 'studyFirstSubmitQcDate': '2021-02-19', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Less surgical procedure time than traditional approaches', 'timeFrame': 'up to two years', 'description': "25 minutes to 45 minutes, it's depends of rotator cuff tear if exist or not."}, {'measure': 'Less rehabilitation time than traditional approaches', 'timeFrame': 'up to two years', 'description': '6 - 8 weeks'}, {'measure': 'Passive physiotherapy immediately', 'timeFrame': 'up to two years', 'description': 'next day of surgery'}, {'measure': 'Active physiotherapy without rotator cuff tear', 'timeFrame': 'up to two years', 'description': 'after two weeks of surgery'}, {'measure': 'Mini cosmetic incision to the shoulder', 'timeFrame': 'up to two years', 'description': '4 - 5 cm'}, {'measure': 'Active physiotherapy with rotator cuff tear', 'timeFrame': 'up to two years', 'description': 'after three weeks of surgery'}], 'secondaryOutcomes': [{'measure': 'very good patients satisfaction', 'timeFrame': 'up to two years', 'description': 'after 8 weeks'}, {'measure': 'Restore deltoid muscle strength', 'timeFrame': 'up to two years', 'description': 'about 3 months after surgery'}]}, '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'], 'conditions': ['Shoulder Impingement Syndrome', 'Rotator Cuff Tendinopathy', 'Adhesive Capsulitis and Frozen Shoulder Syndrome']}, 'descriptionModule': {'briefSummary': 'The incision is very useful and easy for the direct lateral shoulder joint exposure.', 'detailedDescription': 'The skin incision is about 4 to 5 cm made by the distal acromial edge in sagittal plane, The dissection takes place slightly over the acromial edge proximally and over the origin of the acromial deltoid part (the middle part of deltoid origin) distally.\n\nAfter clearly revealing the region of the medial deltoid origin on the acromion, the acromionic deltoid origin is skinned only; of the edge of the acromion, and that maybe accrued by electric knife pen or periosteal elevator, without exposure the clavicular deltoid origin in the front and the deltoid origin on the spine of scapula in the back, the origin of the acromial deltoid is distanced laterally and distally, where the lateral edge, the lower surface of the acromion, under acromial bursa and the rotator cuff are exposed clearly.\n\nThrow this approach can be made acromioplasty and rotator cuff tears repair especially upper part of rotator cuff tear very easily.\n\nFor wound closure the acromionic deltoid origin is reattached to the acromial edge by long period synthetic absorbable sutures as PDS and PDO, or non absorbable sutures as Polyester suture, under skin and skin sutures are made.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '73 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, '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* Un controlled 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\n* Patients with history of Carpal Tunnel release surgery failure'}, 'identificationModule': {'nctId': 'NCT04766905', 'acronym': 'MLSA', 'briefTitle': 'Mini Lateral Shoulder Approach', 'organization': {'class': 'INDIV', 'fullName': 'Issa, Abdulhamid Sayed, M.D.'}, 'officialTitle': 'Mini Lateral Shoulder Approach', 'orgStudyIdInfo': {'id': "Second Sayed Issa's Approach"}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Issa1', 'description': 'Dr.A.Sayed Issa and his team', 'interventionNames': ['Procedure: Mini Lateral Shoulder Approach (MLSA)']}], 'interventions': [{'name': 'Mini Lateral Shoulder Approach (MLSA)', 'type': 'PROCEDURE', 'otherNames': ["Second Sayed Issa's Approach"], 'description': 'The skin incision is about 4 to 5 cm made by the distal acromial edge in sagittal plane, The dissection takes place slightly over the acromial edge proximally and over the origin of the acromial deltoid part (the middle part of deltoid origin) distally.\n\nAfter clearly revealing the region of the medial deltoid origin on the acromion, the acromionic deltoid origin is skinned only; of the edge of the acromion, and that maybe accrued by electric knife pen or periosteal elevator, without exposure the clavicular deltoid origin in the front and the deltoid origin on the spine of scapula in the back, the origin of the acromial deltoid is distanced laterally and distally, where the lateral edge, the lower surface of the acromion, under acromial bursa and the rotator cuff are exposed clearly.', 'armGroupLabels': ['Issa1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aleppo', 'country': 'Syria', 'facility': "Dr. Sayed Issa's Clinic", 'geoPoint': {'lat': 36.20124, 'lon': 37.16117}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Issa, Abdulhamid Sayed, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}