Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-27 @ 5:09 PM
Study NCT ID:
NCT02811757
Status:
UNKNOWN
Last Update Posted:
2016-06-24
First Post:
2016-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes After Arthroscopic Tenotomy or Tenodesis of the Long Head of the Biceps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058971', 'term': 'Tenotomy'}, {'id': 'D053656', 'term': 'Tenodesis'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013536', 'term': 'Suture Techniques'}, {'id': 'D058106', 'term': 'Wound Closure Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'lastUpdateSubmitDate': '2016-06-23', 'studyFirstSubmitDate': '2016-06-21', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Max Peak Torque supination', 'timeFrame': '1 year'}, {'measure': 'Max peak Torque Flexion', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Arthroscopic Rotator Cuff']}, 'descriptionModule': {'briefSummary': 'Degenerative changes of the long head of the biceps brachii (LHB) are frequent and often associated with cuff tendinopathy. The function of the LHB in the shoulder is still controversial and uncertain, whereas its function in the elbow is certain. The biceps brachii is a flexor of the elbow and supinator of the forearm. Suppression of the pathologic long head of the biceps permits pain relief and is very reliable in the literature. Two options are available for the remaining tendon : simple tenotomy or tenodesis which consists to reattach the tendon to the humerus. Our hypothesis is that there is no difference in strength or endurance of the biceps brachii after tenotomy or tenodesis of the LHB. The aim of this study was to compare the strength and the endurance of the biceps brachii during supination and flexion after tenotomy or tenodesis of the LHB.\n\nthe investigators proposed a prospective and randomized study. All the patients treated in our department for an arthroscopic rotator cuff repair were included in this study after signed consent. Participants will complete isokinetic strength and endurance testing for elbow flexion and supination on the operative and nonoperative sides a minimum of 1 year after biceps tenotomy or tenodesis. The clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and SSV at 6 weeks, 3 months, 6 months and one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgery tenotomy or tenodesis type of the long head of the biceps (broken tendinopathy or not rotator cuff escaping a well conducted medical treatment and under a repair or cap pathology of the long head of the biceps during the arthroscopy)\n* Patients treated in the orthopedic service of the Reims University Hospital\n* Patients agreeing to participate in the research and who signed the informed consent\n* Major patients.\n\nExclusion Criteria:\n\n* prior Shoulder Surgery\n* surgery scheduled contralateral shoulder\n* patient protected by law'}, 'identificationModule': {'nctId': 'NCT02811757', 'briefTitle': 'Clinical Outcomes After Arthroscopic Tenotomy or Tenodesis of the Long Head of the Biceps', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Clinical Outcomes After Arthroscopic Tenotomy or Tenodesis of the Long Head of the Biceps', 'orgStudyIdInfo': {'id': 'PA13049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tenodesis', 'interventionNames': ['Procedure: tenodesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tenotomy', 'interventionNames': ['Procedure: tenotomy']}], 'interventions': [{'name': 'tenotomy', 'type': 'PROCEDURE', 'armGroupLabels': ['tenotomy']}, {'name': 'tenodesis', 'type': 'PROCEDURE', 'armGroupLabels': ['tenodesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51092', 'city': 'France', 'state': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Damien JOLLY', 'role': 'CONTACT', 'email': 'djolly@chu-reims.fr', 'phone': '326788472', 'phoneExt': '33'}], 'facility': 'Chu Reims', 'geoPoint': {'lat': 45.60366, 'lon': -0.84802}}], 'centralContacts': [{'name': 'Xavier Ohl', 'role': 'CONTACT', 'email': 'xohl@chu-reims.fr', 'phone': '326783272', 'phoneExt': '33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}