Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-13 @ 2:59 PM
Study NCT ID:
NCT03183466
Status:
UNKNOWN
Last Update Posted:
2017-06-12
First Post:
2017-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Do You Arthroscopic Repair for Subscapularis Tendon Tear, Which Accounts for More Than Half of the 1st Facet? Or do You Perform Debridement?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-08', 'studyFirstSubmitDate': '2017-05-30', 'studyFirstSubmitQcDate': '2017-06-08', 'lastUpdatePostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of Motion (ROM)', 'timeFrame': '2 year postoperatively'}, {'measure': 'Pain Visual Analogue Scale (PVAS)', 'timeFrame': '2 year postoperatively'}, {'measure': "American Shoulder and Elbow Surgeons' score", 'timeFrame': '2 year postoperatively'}, {'measure': 'Constant score', 'timeFrame': '2 year postoperatively'}, {'measure': 'Korean Shoulder Score (KSS) score', 'timeFrame': '2 year postoperatively'}], 'secondaryOutcomes': [{'measure': 'repair integrity analysis using postoperative MRI', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subscapularis Tendon Tear', 'Arthroscopic Repair', 'Arthroscopic Debridement']}, 'referencesModule': {'references': [{'pmid': '11987054', 'type': 'BACKGROUND', 'citation': 'Burkhart SS, Tehrany AM. Arthroscopic subscapularis tendon repair: Technique and preliminary results. Arthroscopy. 2002 May-Jun;18(5):454-63. doi: 10.1053/jars.2002.30648.'}, {'pmid': '22632896', 'type': 'BACKGROUND', 'citation': 'Denard PJ, Jiwani AZ, Ladermann A, Burkhart SS. Long-term outcome of a consecutive series of subscapularis tendon tears repaired arthroscopically. Arthroscopy. 2012 Nov;28(11):1587-91. doi: 10.1016/j.arthro.2012.02.031. Epub 2012 May 24.'}, {'pmid': '17055750', 'type': 'BACKGROUND', 'citation': 'Flury MP, John M, Goldhahn J, Schwyzer HK, Simmen BR. Rupture of the subscapularis tendon (isolated or in combination with supraspinatus tear): when is a repair indicated? J Shoulder Elbow Surg. 2006 Nov-Dec;15(6):659-64. doi: 10.1016/j.jse.2005.07.013. Epub 2006 Oct 19.'}, {'pmid': '37548022', 'type': 'DERIVED', 'citation': 'Jeong JY, Kim SC, Lee SM, Yoo JC. Prospective Randomized Clinical Trial of Arthroscopic Repair Versus Debridement for Partial Subscapularis Tendon Tears More Than Half of the Entire First Facet. Am J Sports Med. 2023 Sep;51(11):2804-2814. doi: 10.1177/03635465231187033. Epub 2023 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to randomly classify the upper third of the subscapularis in 1/2 of the rupture patients as preoperative group (arthroscopic and arthroscopic debridement group) and the difference between clinical and clinical scores.', 'detailedDescription': 'The degree of rupture that is an adaptation of arthroscopic surgery is now known to be about one-third to one-half of a rupture. However, the most controversial case is the one-third to one-half of the upper tear attached to the tendinous portion of the subscapularis. Currently, debridement or repair is under way. But evidence-based studies are lacking and no clear treatment guidelines are available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subscapularis tendon tear from more than 1/2 to entire of 1st facet found during routine arthroscopy with 70 degree scope\n* Isolated or combined with Supraspinatus and/or Infraspinatus tear (SS/IS tear less than 3 cm)\n* Combined biceps lesion\n* Combined acromial clavicle (AC) arthritis\n\nExclusion Criteria:\n\n* Revision case or previous surgical history of the index shoulder\n* Any open surgery, including open repair of the subscapularis tendon\n* Compensation case\n* Combined severe arthritis of the glenohumeral joint\n* Patient who selects one's own surgical method, i.e. not randomized\n* Infection, tumor, etc"}, 'identificationModule': {'nctId': 'NCT03183466', 'briefTitle': 'Do You Arthroscopic Repair for Subscapularis Tendon Tear, Which Accounts for More Than Half of the 1st Facet? Or do You Perform Debridement?', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Prospective Randomized Clinical Trial of Arthroscopic Repair Versus Debridement for Subscapularis Tendon Tear More Than 1/2 to Entire 1st Facet (Representing 1/3 to More Than 1/3 Tear of Subscapularis Entire Footprint)', 'orgStudyIdInfo': {'id': '2011-11-029-025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients included in inclusion criteria', 'interventionNames': ['Procedure: arthroscopic repair', 'Procedure: arthroscopic debridement']}], 'interventions': [{'name': 'arthroscopic repair', 'type': 'PROCEDURE', 'armGroupLabels': ['Patients included in inclusion criteria']}, {'name': 'arthroscopic debridement', 'type': 'PROCEDURE', 'armGroupLabels': ['Patients included in inclusion criteria']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}