Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-30 @ 1:52 AM
Study NCT ID:
NCT04686968
Status:
UNKNOWN
Last Update Posted:
2020-12-29
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in Treating of Rotator Cuff Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D015775', 'term': 'Fractures, Stress'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-28', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-28', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Shoulder and Elbow Surgeons Shoulder (ASES) score', 'timeFrame': '1 year postoperatively', 'description': 'A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome'}, {'measure': 'American Shoulder and Elbow Surgeons Shoulder (ASES) score', 'timeFrame': '2 years postoperatively', 'description': 'A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome'}, {'measure': 'tendon integrity', 'timeFrame': '1 year postoperatively', 'description': 'MRI was used to assess the integrity of the repaired rotator cuff tendon'}, {'measure': 'Visual Analogue Scale(VAS)', 'timeFrame': '1 year postoperatively', 'description': 'A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome'}, {'measure': 'Visual Analogue Scale(VAS)', 'timeFrame': '2 year postoperatively', 'description': 'A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rotator cuff tear', 'Microfractures', 'greenhouse', 'Suture Bridge Technique'], 'conditions': ['Rotator Cuff Tears', 'Microfractures']}, 'referencesModule': {'references': [{'pmid': '23522987', 'type': 'BACKGROUND', 'citation': 'Milano G, Saccomanno MF, Careri S, Taccardo G, De Vitis R, Fabbriciani C. Efficacy of marrow-stimulating technique in arthroscopic rotator cuff repair: a prospective randomized study. Arthroscopy. 2013 May;29(5):802-10. doi: 10.1016/j.arthro.2013.01.019. Epub 2013 Mar 21.'}, {'pmid': '32976717', 'type': 'BACKGROUND', 'citation': 'Kim C, Lee YJ, Kim SJ, Yoon TH, Chun YM. Bone Marrow Stimulation in Arthroscopic Repair for Large to Massive Rotator Cuff Tears With Incomplete Footprint Coverage. Am J Sports Med. 2020 Nov;48(13):3322-3327. doi: 10.1177/0363546520959314. Epub 2020 Sep 25.'}, {'pmid': '25487905', 'type': 'BACKGROUND', 'citation': 'Taniguchi N, Suenaga N, Oizumi N, Miyoshi N, Yamaguchi H, Inoue K, Chosa E. Bone marrow stimulation at the footprint of arthroscopic surface-holding repair advances cuff repair integrity. J Shoulder Elbow Surg. 2015 Jun;24(6):860-6. doi: 10.1016/j.jse.2014.09.031. Epub 2014 Dec 2.'}]}, 'descriptionModule': {'briefSummary': 'Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.', 'detailedDescription': 'Arthroscopic rotator cuff repair has a high rate of successful subjective and functional results. Although the rate of tendon healing is reported to be around 80% for small tears, it can decrease to about 30% for large and massive tears. Poor tissue quality of bone, tendons, and muscles can affect healing and functional recovery of the rotator cuff and has been advocated as a major cause of tendon nonhealing and/or retear. Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medium-sized full-thickness rotator cuff tear confirmed during shoulder arthroscopy\n* Between 20-65 years old\n\nExclusion Criteria:\n\n* Bilateral rotator cuff tear\n* Underwent ipsilateral surgery\n* Large-to-massive rotator cuff tear\n* Combined with Bankart, SLAP or AC lesion\n* Combined with diabetes, smoking, immune disease, osteoporosis, and large nodular cystic degeneration'}, 'identificationModule': {'nctId': 'NCT04686968', 'briefTitle': 'Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in Treating of Rotator Cuff Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Jishuitan Hospital'}, 'officialTitle': 'Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in the Treatment of Medium-sized Full-thickness Rotator Cuff Injuries: A Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'CJiang-Greenhouse'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Greenhouse group', 'description': 'Patients underwent greenhouse technique：The high-strength suture was passed through the tendon using Mason-Allen method, and then Crimson duvet procedure was performed on the foot print area from the articular surface of the humeral head to the apex of the greater tubercle. Immediately after this procedure, a lateral row anchor was used.', 'interventionNames': ['Procedure: Greenhouse Technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vent group', 'description': 'The three-line anchor suture method is the same as before, the position is between the apex of the greater tubercle and the articular surface. After the rotator cuff is sutured, the bone bed beyond the suture point to the outer edge of the greater tubercle is opened with 2.0mm Kirschner wire every 5mm ( Crimson duvet), 1cm in depth, about 6 in total.', 'interventionNames': ['Procedure: Microfracture Combined With Suture Bridge Technique']}], 'interventions': [{'name': 'Greenhouse Technique', 'type': 'PROCEDURE', 'description': 'First, the high-strength sutures were passed through the teared tendon, and then Crimson duvet procedure was performed on the footprint from the articular margin of the humeral head to the apex of the greater tubercle, followed by a lateral row anchor.', 'armGroupLabels': ['Greenhouse group']}, {'name': 'Microfracture Combined With Suture Bridge Technique', 'type': 'PROCEDURE', 'description': 'A three-line anchor suture method is used as in the greenhouse technique, except that the position is between the apex of the greater tubercle and the articular surface. After the rotator cuff is sutured, the bone bed beyond the suture point to the outer edge of the greater tubercle is opened with 2.0mm Kirschner wire every 5mm ( Crimson duvet), 1cm in depth, about 6 in total.', 'armGroupLabels': ['Vent group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhijun Zhang, M.D.', 'role': 'CONTACT', 'email': 'zzj5285029@163.com', 'phone': '+86 15201277648'}], 'overallOfficials': [{'name': 'Chunyan Jiang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sports Medicine Service, Beijing Jishuitan hospital'}]}, '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': 'Chunyan Jiang', 'investigatorAffiliation': 'Beijing Jishuitan Hospital'}}}}