Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-02-01 @ 2:32 PM
Study NCT ID:
NCT03362320
Status:
UNKNOWN
Last Update Posted:
2020-07-14
First Post:
2017-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-11', 'studyFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2017-12-04', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retear rate', 'timeFrame': '12 months postoperatively', 'description': 'Comparison of re-ruptures rate evaluated with magnetic resonance imaging between groups'}], 'secondaryOutcomes': [{'measure': 'Constant-Murley score', 'timeFrame': 'baseline, 24 and 60 months postoperatively', 'description': 'Comparison of the total Constant-Murley score (min 0 to max 100; higher values represent a better outcome) between groups'}, {'measure': 'Range of motion (ROM)', 'timeFrame': 'baseline, 24 and 60 months postoperatively', 'description': 'Comparison of ROMs between groups'}, {'measure': 'Satisfaction with the procedure', 'timeFrame': '24 and 60 months postoperatively', 'description': "Comparison of satisfaction with the procedure between groups. Satisfaction is evaluated by asking patients one question to rate their satisfaction with the procedure based on a likert scale (4 = 'very satisfied', 3 = 'quite satisfied', 2 = 'moderately satisfied', 1 = 'less satisfied', 0 = 'not at all satisfied')."}, {'measure': 'VAS', 'timeFrame': 'baseline, 24 and 60 months postoperatively', 'description': 'Comparison of the Visual Analogue Scale (VAS) between groups'}, {'measure': 'SST', 'timeFrame': 'baseline and 24 months postoperatively', 'description': 'Comparison of the Simple Shoulder Test (SST) between groups'}, {'measure': 'ASES', 'timeFrame': 'baseline, 24 and 60 months postoperatively', 'description': 'Comparison of the American Shoulder and Elbow Surgeons score (ASES) between groups. The ASES is a patient-rated questionnaire with a total between 0 and 100 points with higher scores indicating better outcome.'}, {'measure': 'qDASH', 'timeFrame': 'baseline, 24 and 60 months postoperatively', 'description': 'Comparison of the quick Disability of the Arm, Shoulder and Hand (qDASH) between groups'}, {'measure': 'WORC', 'timeFrame': 'baseline and 24 months postoperatively', 'description': 'Comparison of the Western Ontario Rotator Cuff Index (WORC) between groups'}, {'measure': 'SSV', 'timeFrame': 'baseline, 24 and 60 months postoperatively', 'description': 'Comparison of the Simple Soulder Value (SSV) between groups'}, {'measure': 'SF-36', 'timeFrame': 'baseline, 24 and 60 months postoperatively', 'description': 'Comparison of the quality-of-life score short form 36 (SF-36) between groups'}, {'measure': 'Tendon integrity', 'timeFrame': 'baseline and 60 months postoperatively', 'description': 'Comparison of tendon integrity (re-tear / no re-tear) evaluated with magnetic resonance imaging between groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Tear']}, 'referencesModule': {'references': [{'pmid': '31917608', 'type': 'DERIVED', 'citation': 'Heuberer PR, Pauzenberger L, Gruber MS, Ostermann RC, Hexel M, Laky B, Anderl W. Delaminated Rotator Cuff Tears Showed Lower Short-term Retear Rates After Arthroscopic Double-Layer Repair Versus Bursal Layer-Only Repair: A Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(3):689-696. doi: 10.1177/0363546519897033. Epub 2020 Jan 9.'}]}, 'descriptionModule': {'briefSummary': "Retear rates after arthroscopic rotator cuff repairs remain unsatisfactorily high. Recently, attention has been paid to restore the rotator cuff's native anatomy by reconstructing the superior joint capsule. However, the debate whether to reconstruct only the superficial tendinous part or also the deeper capsulo-ligamentous part of the rotator cuff is ongoing. Thus, the intention of the present study is to compare double-layer versus single-layer arthroscopic rotator cuff repair regarding retear rate and clinical outcome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with repairable supra- and infraspinatus tears scheduled for arthroscopic rotator cuff fixation\n* tear size of at least 2.5 cm and up to 4.0 cm\n* signed informed consent\n\nExclusion Criteria:\n\n* axillary nerve palsy'}, 'identificationModule': {'nctId': 'NCT03362320', 'briefTitle': 'Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation', 'organization': {'class': 'OTHER', 'fullName': 'Austrian Research Group for Regenerative and Orthopedic Medicine'}, 'officialTitle': 'A Randomized Clinical Trial Comparing Arthroscopic Double- Versus Single-layer Reconstruction of the Rotator Cuff: Clinical and Radiological Outcome', 'orgStudyIdInfo': {'id': 'SLvsDL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'double layer fixation', 'description': 'Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with double layer fixation', 'interventionNames': ['Procedure: double layer fixation']}, {'type': 'EXPERIMENTAL', 'label': 'single layer fixation', 'description': 'Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with single layer fixation', 'interventionNames': ['Procedure: single layer fixation']}], 'interventions': [{'name': 'double layer fixation', 'type': 'PROCEDURE', 'armGroupLabels': ['double layer fixation']}, {'name': 'single layer fixation', 'type': 'PROCEDURE', 'armGroupLabels': ['single layer fixation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'St. Vincent Shoulder & Sports Clinic', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Werner Anderl, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Austrian Research Group for Regenerative and Orthopedic Medicine'}, {'name': 'Philipp R Heuberer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Austrian Research Group for Regenerative and Orthopedic Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Austrian Research Group for Regenerative and Orthopedic Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Philipp Heuberer', 'investigatorAffiliation': 'Austrian Research Group for Regenerative and Orthopedic Medicine'}}}}