Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT05960812
Status:
UNKNOWN
Last Update Posted:
2023-09-22
First Post:
2023-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Skillful Neglect Vs Repair For Subscapularis Tear Associated With Posterosuperior Cuff Tears Repair.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-09-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2023-05-20', 'studyFirstSubmitQcDate': '2023-07-22', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'american shoulder elbow score', 'timeFrame': 'after 6months and 12 months', 'description': 'scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points.'}], 'secondaryOutcomes': [{'measure': 'Visual analogue score', 'timeFrame': 'Post operative 6months and 12 months', 'description': 'subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rotator cuff tear'], 'conditions': ['Subscapularis Muscle Strain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare functional outcomes of Skillful Neglect \\& arthroscopic repair of upper border subscapularis tear in La fosse type 1 and type 2 with biceps tenotomy in non-athletes,30 shoulders subdivided randomly into 2 groups, 15 patients in group 1 (patient treated by skillful neglect with biceps tenotomy) and 15 patients in group 2 (patients treated by arthroscopic repair with biceps tenotomy)', 'detailedDescription': 'patients are randomized chosen then a shoulder arthroscope is done for all patients with biceps tenotomy but in group1 the investigators are neglecting the upper border tears and in group 2 the investigators are repairing upper border tears with anchors then after the procedure is completed the investigators will follow up by ASES score'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with combined upper subscapularis border tear in Lafosse type 1 and type 2.\n\nExclusion Criteria:\n\n* Glenohumeral arthritis.\n* Patients with other intra-articular pathology like SLAP lesions.\n* Neural damage (Brachial plexus injury).\n* Revision cases.\n* Patient with subscapularis border tear type 3, type 4, and type 5.'}, 'identificationModule': {'nctId': 'NCT05960812', 'briefTitle': 'Skillful Neglect Vs Repair For Subscapularis Tear Associated With Posterosuperior Cuff Tears Repair.', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Skillful Neglect Vs Repair For Upper Border Subscapularis Tear Associated With Posterosuperior Cuff Tears Repair In Non-Athletes: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FMASU MD 218/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1 (patient treated by skillful neglect with biceps tenotomy)', 'description': 'neglect of upper border subscapularis tear and doing biceps tenotomy', 'interventionNames': ['Procedure: skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .', 'Procedure: arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 2 (patient treated by arthroscopic repair with biceps tenotomy)', 'description': 'repair of upper border subscapularis tear and doing biceps tenotomy', 'interventionNames': ['Procedure: skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .', 'Procedure: arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .']}], 'interventions': [{'name': 'skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .', 'type': 'PROCEDURE', 'description': 'The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear conservative treatment which is considered the standard technique.\n\n* Semisetting position under GA.\n* Standard shoulder arthroscopy with standard portals for RC repair.\n* Inspection of articular surface of rotator cuff and biceps tendon.\n* Bursectomy, visualization of all rotators.\n* Mobilization is done for associated rotator tears by shaver and radiofrequency device.\n* Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear.\n* Skillful neglect to the tear.\n* Rotator repair technique by RC anchors\n* Biceps Tenotomy will be done in all cases by cutting of LHBT.', 'armGroupLabels': ['group 1 (patient treated by skillful neglect with biceps tenotomy)', 'group 2 (patient treated by arthroscopic repair with biceps tenotomy)']}, {'name': 'arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .', 'type': 'PROCEDURE', 'description': 'The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear repair which is considered the standard technique.\n\n* Semisetting position under GA.\n* Standard shoulder arthroscopy with standard portals for RC repair.\n* Inspection of articular surface of rotator cuff and biceps tendon.\n* Bursectomy, visualization of all rotators.\n* Mobilization is done for associated rotator tears by shaver and radiofrequency device.\n* Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear.\n* Skillful neglect to the tear.\n* Rotator repair technique by RC anchors\n* Biceps Tenotomy will be done in all cases by cutting of LHBT.', 'armGroupLabels': ['group 1 (patient treated by skillful neglect with biceps tenotomy)', 'group 2 (patient treated by arthroscopic repair with biceps tenotomy)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mohamed ashraf, master', 'role': 'CONTACT', 'email': 'mohamedkhamis657@gmail.com', 'phone': '00201022677132'}], 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed As Abdallah', 'role': 'CONTACT', 'email': 'mohamedkhamis657@gmail.com', 'phone': '00201022677132'}, {'name': 'Yahia Mo Haroun', 'role': 'CONTACT', 'phone': '00201006124615'}], 'overallOfficials': [{'name': 'mohamed as abdallah, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}, {'name': 'Amr Mo Abdelhady', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}, {'name': 'Maged Mo Samy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}, {'name': 'Mohamed Ha Sobhy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}, {'name': 'Yahia Mo Haroun', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Ashraf Abdallah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mohamed Ashraf Abdallah', 'investigatorAffiliation': 'Ain Shams University'}}}}