Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-26 @ 12:48 AM
Study NCT ID:
NCT07289334
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2025-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tenotomy Versus no Tenotomy LHB in Rotator Cuff Repair
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients were randomly assigned to two groups, TENOTOMY (n=25) and NO TENOTOMY (n=29), using a centralized random number program.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Constant Murley', 'timeFrame': '24 month', 'description': '100-point standardized tool for assessing shoulder function, comprising four domains Pain (0-15 points) daily life activity (0-20 points) range of motion (0-40 points) strenght (0-25 points)\n\n0 (the worst) - 100 (the best)'}], 'secondaryOutcomes': [{'measure': 'ASES', 'timeFrame': '24 MONTHS', 'description': 'The ASES score (American Shoulder and Elbow Surgeons score) is a 100-point questionnaire used to assess shoulder function and pain, with a higher score indicating better outcomes.\n\nFrom 0 (worst) to 100 (best).'}, {'measure': 'cross sectional area of the LHBT', 'timeFrame': '24 months', 'description': 'Ultrasound Imaging: Integrity of the supraspinatus tendon (SST) repair, presence of the long head of the biceps tendon (LHBT) in the bicipital groove (BG), and cross-sectional area of the LHBT at three levels of the BG (proximal, middle, and distal).\n\nmesured in mm2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['long head biceps', 'rotator cuff tears', 'tenotomy', 'no tenotomy'], 'conditions': ['Long Head of Biceps Brachii Lesions', 'Rotator Cuff Tears']}, 'descriptionModule': {'briefSummary': 'The function of the long head of the biceps tendon (LHBT) in the glenohumeral joint generates controversy among researchers. For some, the tendon does not have a significant function in the shoulder, while others consider it acts as a depressor of the humeral head and a stabilizer of the joint. These functions may be enhanced in cases of rotator cuff injuries, where compensatory hypertrophy and/or instability of the LHBT can occur, which can also be a source of pain. One of the imaging techniques used for diagnosing these injuries is ultrasound.\n\nInitially, G. Walch proposed tenotomy of the LHBT in massive rotator cuff tears to improve pain and, in some cases, shoulder function. Currently, many authors advocate tenotomy of the LHBT as an adjunct to rotator cuff repair to avoid postoperative pain. However, there is no evidence that this procedure improves the clinical outcomes of isolated rotator cuff repair.\n\nBased on the pathophysiology of the LHBT associated with rotator cuff injuries and the current trend to perform tenotomies in conjunction with cuff repair, the objectives of this doctoral thesis project were:\n\nTo compare the clinical and imaging outcomes of arthroscopic rotator cuff repairs with and without LHBT tenotomy.\n\nTo analyze the position and cross-sectional area of the LHBT in the bicipital groove using ultrasound in cases with and without tenotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 40 and 65 years\n* Partial supraspinatus tears (≥ 50% thickness)\n* Complete supraspinatus tears ≤ 3 cm in the coronal plane\n* Muscle atrophy less than stage 2 according to Thomazeau\n* Presence of the LHBT in the bicipital groove\n\nExclusion Criteria:\n\n* Patients younger than 40 or older than 65 years\n* LHBT rupture\n* Partial supraspinatus tears \\< 50% thickness\n* Supraspinatus tears \\> 3 cm\n* Tears of other rotator cuff tendons, with or without supraspinatus involvement\n* Traumatic tears with surgery performed less than 3 months after injury\n* Muscle atrophy ≥ stage 2 Thomazeau\n* Associated degenerative glenohumeral pathology (\\> Samilson 1)\n* Previous shoulder surgeries\n* Previous shoulder infections\n* Associated peripheral neurological injuries\n* Degenerative neurological conditions\n* Patients who refused to sign informed consent'}, 'identificationModule': {'nctId': 'NCT07289334', 'briefTitle': 'Tenotomy Versus no Tenotomy LHB in Rotator Cuff Repair', 'organization': {'class': 'OTHER', 'fullName': 'Consorci Sanitari de Terrassa'}, 'officialTitle': 'Tenotomy Versus no Tenotomy of the Long Head of the Biceps in Rotator Cuff Repair: Clinical-functional Analysis and Ultrasound Evaluation', 'orgStudyIdInfo': {'id': '02-14-105-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'NO TENOTOMY', 'description': 'NO TENOTOMY OF LHBT + ROTATOR CUFF REPAIR', 'interventionNames': ['Procedure: ROTATOR CUFF REPAIR']}, {'type': 'EXPERIMENTAL', 'label': 'TENOTOMY', 'description': 'TENOTOMY OF LHBT + ROTATOR CUFF REPAIR', 'interventionNames': ['Procedure: ROTATOR CUFF REPAIR']}], 'interventions': [{'name': 'ROTATOR CUFF REPAIR', 'type': 'PROCEDURE', 'description': 'ROTATOR CUFF REPAIR', 'armGroupLabels': ['NO TENOTOMY', 'TENOTOMY']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consorci Sanitari de Terrassa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Surgeon of Shoulder Unit, Consorci Sanitari de Terrassa', 'investigatorFullName': 'Josep Maria Mora Guix', 'investigatorAffiliation': 'Consorci Sanitari de Terrassa'}}}}