Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT05792202
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2023-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Microfracture Procedure Promotes Tendon Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2023-03-18', 'studyFirstSubmitQcDate': '2023-03-18', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rotator cuff re-tear rate', 'timeFrame': '2 year postoperatively', 'description': 'the rotator cuff re-tear rate was measured by MRI, MRI was performed to identify the status of the tendon'}], 'secondaryOutcomes': [{'measure': 'VAS (Visual Analogue Scale)', 'timeFrame': '1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively, higher scores mean a worse outcome.', 'description': 'A score used to evaluate the pain'}, {'measure': "ASES（American Shoulder and Elbow Surgeons'Form）", 'timeFrame': '3,6,12,24 months postoperatively', 'description': 'A score used to evaluate the shoulder function, higher scores mean a better outcome.'}, {'measure': 'Constant score', 'timeFrame': '3,6,12,24 months postoperatively', 'description': 'A score used to evaluate the shoulder function, higher scores mean a better outcome.'}, {'measure': 'UCLA (University LosAngeles scoring system)', 'timeFrame': '3,6,12,24 months postoperatively', 'description': 'A score used to evaluate the shoulder function, higher scores mean a better outcome.'}, {'measure': 'SST (simple shoulder test)', 'timeFrame': '3,6,12,24 months postoperatively', 'description': 'A score used to evaluate the shoulder function, higher scores mean a better outcome.'}, {'measure': 'front extension, external rotation and internal rotation strength of shoulder', 'timeFrame': '6,12,24 months postoperatively', 'description': 'Use a dynamometer to measure in N'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Full Rotator Cuff Tear', 'Microfracture Procedure', 'Double Raw Repair']}, 'descriptionModule': {'briefSummary': 'This study is a prospective randomized controlled study of Combined microfracture procedure promotes tendon healing during double raw repair for full tear rotator cuff. The patients with rotator cuff tear were randomly divided into groups before the operation. The patients were followed up before and 6 weeks, 3 months, 6 months, 12 months after surgery. In different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, MRI performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of Crimson duvet procedure with Greenhouse procedure on the treatment of rotator cuff.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Arthroscopy confirmed small to medium full rotator cuff tear\n* Unilateral rotator cuff injury\n* Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients\n* Young and middle-aged patients aged 20 to 60\n\nExclusion Criteria:\n\n* Previous shoulder surgery (incision or arthroscopy)\n* Combined with diseases of other parts of the same limb\n* Combined with Bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on\n* Bilateral onset\n* Unable or unwilling to receive clinical follow-up'}, 'identificationModule': {'nctId': 'NCT05792202', 'briefTitle': 'Combined Microfracture Procedure Promotes Tendon Healing', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Jishuitan Hospital'}, 'officialTitle': 'Combined Microfracture Procedure Promotes Tendon Healing During Double Raw Repair for Full Tear Rotator Cuff - a Prospective Randomized Study With 2-year Follow-up', 'orgStudyIdInfo': {'id': 'LY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'double raw repair for full tear rotator cuff combined microfracture procedure', 'interventionNames': ['Procedure: microfracture procedure']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'double raw repair for full tear rotator cuff', 'interventionNames': ['Procedure: only double raw repair']}], 'interventions': [{'name': 'microfracture procedure', 'type': 'PROCEDURE', 'description': 'double raw repair combined with microfracture procedure which promotes tendon healing by releasing growth factors', 'armGroupLabels': ['Study group']}, {'name': 'only double raw repair', 'type': 'PROCEDURE', 'description': 'the double raw repair was used to repair the tendon tear', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shangzhe Li, M.D.', 'role': 'CONTACT', 'email': '562744381@qq.com', 'phone': '+86 13826162999'}], 'facility': 'Beijing Jishuitan hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shangzhe Li, M.D.', 'role': 'CONTACT', 'email': '562744381@qq.com', 'phone': '+86 13826162999'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Jishuitan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Sports Medicine Service of Beijing Jishuitan hospital', 'investigatorFullName': 'Yi Lu', 'investigatorAffiliation': 'Beijing Jishuitan Hospital'}}}}