Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-27 @ 12:44 PM
Study NCT ID:
NCT04494932
Status:
COMPLETED
Last Update Posted:
2024-08-12
First Post:
2020-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SLAP Repair vs. Biceps Tenodesis in Patients Under 30: A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070599', 'term': 'Shoulder Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2020-07-28', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Score on Visual Analogue Scale (VAS) Scale', 'timeFrame': '3 months post-op, 24 months post-op', 'description': 'The visual analog scale (VAS) is a validated, 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 possible." The total score range is 0-10. The higher the score, the higher the pain level experienced.'}], 'secondaryOutcomes': [{'measure': 'Change in Score on American Shoulder & Elbow Surgeons (ASES) Scale', 'timeFrame': '3 months post-op, 24 months post-op', 'description': 'The ASES scale consists of two subscales: pain (0-50 points) and function/disability (0-50 points), with a total score range of 0-100 points. The lower the score, the greater the pain and disability.'}, {'measure': 'Change in Score on Kerlan-Jobe Orthopaedic Clinical Shoulder & Elbow (KJOC) Questionnaire', 'timeFrame': '3 months post-op, 24 months post-op', 'description': 'The KJOC Score includes 10 questions with an 11-point Likert scale in the form of blocks to be ticked from 0 to 10. The total score is equal to the sum of the values of the 10 responses. The higher the score, the greater the shoulder function.'}, {'measure': 'Change in Score on Shoulder Instability-Return to Sport after Injury (SIRSI) Questionnaire', 'timeFrame': '3 months post-op, 24 months post-op', 'description': 'The SIRSI includes 12 questions with an 11-point Likert scale in the form of blocks to be ticked from 0 to 10. The total score is equal to the sum of the values of the 12 responses then determined in relation to 100 to obtain a percentage (0-100%). The higher the score (%), the more positive the psychological response.'}, {'measure': 'Average timing of return to work/sport', 'timeFrame': 'up to 24 months post-op'}, {'measure': 'Incidence of re-operations', 'timeFrame': 'up to 24 months post-op'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SLAP Repair', 'Biceps Tenodesis'], 'conditions': ['SLAP Tear']}, 'descriptionModule': {'briefSummary': 'One of the common complaints after SLAP repair is pain and stiffness. However, the more recently-described Biceps Tenodesis for SLAP tears improves upon this by addressing the long head of biceps which is thought to be the pain sources. However, only one small prior RCT has evaluated this, finding minimal difference. Both procedures are currently considered standard of care, and are decided upon based on patient and surgeon preference.\n\nThis will be a single-center randomized controlled trial. The study is comparing SLAP repair and biceps tenodesis in patients under 30 undergoing surgery for SLAP tears. The purpose of the proposed study is to evaluate the effect of SLAP repair versus biceps tenodesis in the management of SLAP tears in patients under 30 years old.', 'detailedDescription': 'Superior-labrum anterior to posterior (SLAP) tears were first described by Andrews et al. in 1985, and have been reported to be present in up to 26% of shoulder arthroscopies. While the exact cause of SLAP tears is unknown, they are often related to traumatic events and sports activity, particularly overhead sports such as baseball. Type II SLAP tears, which are characterized by superior labral fraying with a detached biceps anchor, are the most common subtype, based on the classification by Snyder et al. Treatment options include SLAP repair, biceps tenodesis, biceps tenotomy, and debridement.\n\nOne of the common complaints after SLAP repair is pain and stiffness. However, the more recently-described Biceps Tenodesis for SLAP tears improves upon this by addressing the long head of biceps which is thought to be the pain sources. However, only one small prior RCT has evaluated this, finding minimal difference. Both procedures are currently considered standard of care, and are decided upon based on patient and surgeon preference.\n\nThis will be a single-center randomized controlled trial. The study is comparing SLAP repair and biceps tenodesis in patients under 30 undergoing surgery for SLAP tears. The purpose of the proposed study is to evaluate the effect of SLAP repair versus biceps tenodesis in the management of SLAP tears in patients under 30 years old.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary indication is for SLAP tear\n* Age 18-30\n* Willing and able to provide consent\n\nExclusion Criteria:\n\n* Associated rotator cuff tear requiring arthroscopic repair\n* Pregnant patient\n* Previous shoulder surgery\n* Age \\> 30, or \\< 18'}, 'identificationModule': {'nctId': 'NCT04494932', 'briefTitle': 'SLAP Repair vs. Biceps Tenodesis in Patients Under 30: A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'SLAP Repair vs. Biceps Tenodesis in Patients Under 30: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '20-01027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biceps Tenodesis', 'interventionNames': ['Procedure: Biceps Tenodesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SLAP Repair (Control)', 'interventionNames': ['Procedure: Self-Locking Tenotomy']}], 'interventions': [{'name': 'Self-Locking Tenotomy', 'type': 'PROCEDURE', 'otherNames': ['SLAP Repair'], 'description': 'Self-locking Tenotomy describes the surgical procedure that will be performed to treat SLAP tears.', 'armGroupLabels': ['SLAP Repair (Control)']}, {'name': 'Biceps Tenodesis', 'type': 'PROCEDURE', 'description': 'Biceps tenodesis describes the surgical procedure that will be performed to treat SLAP tears.', 'armGroupLabels': ['Biceps Tenodesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Laith Jazrawi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.', 'accessCriteria': 'The investigator who proposed to use the data will have access to use the data upon reasonable request. Requests should be directed to laith.jazrawi@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}