Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-02-20 @ 6:05 PM
Study NCT ID:
NCT02943005
Status:
UNKNOWN
Last Update Posted:
2016-12-16
First Post:
2016-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-operative Mobilisation After Rotator Cuff Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-15', 'studyFirstSubmitDate': '2016-10-09', 'studyFirstSubmitQcDate': '2016-10-21', 'lastUpdatePostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Return to sports', 'timeFrame': '6 months', 'description': 'Yes/no'}, {'measure': 'Work absenteeism', 'timeFrame': '6 months', 'description': 'Months'}, {'measure': 'Complications (i.e frozen shoulder)', 'timeFrame': '6 months', 'description': 'Description of complication'}, {'measure': 'Number of physiotherapy sessions needed.', 'timeFrame': '6 months', 'description': 'Clinical evolution'}, {'measure': 'VAS score', 'timeFrame': '1.5, 3, and 6 months', 'description': 'Graded between 0 and 10'}, {'measure': 'Constant score', 'timeFrame': '1.5, 3, and 6 months', 'description': 'Clinical scores number between 0-100'}, {'measure': 'SANE score', 'timeFrame': '1.5, 3, and 6 months', 'description': 'Clinical scores number between 0-10'}, {'measure': 'ASES score', 'timeFrame': '1.5, 3, and 6 months', 'description': 'Clinical scores number between 0-100'}, {'measure': 'Strength of arms in Jobe position', 'timeFrame': '6 months', 'description': 'Strength measurement in kilo according to the technique of Int Shoulder Surg Collin et al. In press'}], 'primaryOutcomes': [{'measure': 'ASES score', 'timeFrame': '3 months', 'description': 'Clinical score (0-100)'}], 'secondaryOutcomes': [{'measure': 'Retear or non healing of the rotator cuff', 'timeFrame': '6 months', 'description': 'Ultrasound control'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rotator Cuff']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare rehabilitation with the wearing of a sling, to rehabilitation without any immobilization after an arthroscopic repair of the supraspinatus tendon. The goal is to offer to patients a simplified rehabilitation management, with a faster recovery, less pain and a quicker return to normal life.', 'detailedDescription': "Rotator cuff tear is a frequent problem, increasing with age1. Thus arthroscopic repair is a frequent surgery. Despite this important number of cuff repair, the re-tear rate varies from 20 to 90% depending on tear severity and type of repair1,2. Many factors are implicated in tendon healing and post-operative clinical results. Some are unchangeable (age, tear size, chronicity…) but some are under the surgeon control like the surgical technique and the post-operative rehabilitation protocol. It exists many surgical repair techniques6, 7, with a massive development of technology during the last twenty years. However in terms of rehabilitation, there is only few studies and evidence of best practices4. The main aspect on which the surgeon can act, is the immobilization time. Actually, standard protocols include an immobilisation of 4 to 6 weeks before physiotherapy beginning5.\n\nA recent review of the literature3 has highlighted five studies comparing different rehabilitation protocols, which include different immobilization periods ranging from 0 to 8 weeks, and different types of mobilization (under physiotherapist supervision or not, with machine or not). They found a similar rate of re-tear between the different protocols. But early passive motion enables to improve the range of motion during first 3-6 months, with similar results at one year.\n\nHowever in all these studies, all patients had to wear a sling for at least 4 weeks, even in the early mobilization group. But the investigators don't know if this sling is really useful, probably not if the investigators follow the logic of faster recovery and same long term results with early mobilization. At our best knowledge, no study has sought to compare the usefulness of sling wearing after a rotator cuff repair. Removing sling could simplify rehabilitation and should provide a return to normal function faster, with greater satisfaction and a similar rate of re-tear.\n\nThe aim of this study is to compare rehabilitation with the wearing of a sling, to rehabilitation without any immobilization after an arthroscopic repair of the supraspinatus tendon."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old\n* Small tear (\\< 3cm) of the supraspinatus tendon\n* Arthroscopic cuff repair\n\nExclusion Criteria:\n\n* Lesion of the anterior or posterior rotator cuff\n* Significant other trauma of the involved upper member (e.g. associated scapular or clavicular fractures, acromioclavicular dislocation)\n* Preoperative shoulder stiffness\n* Inability to follow properly post-surgery recommendations.'}, 'identificationModule': {'nctId': 'NCT02943005', 'briefTitle': 'Post-operative Mobilisation After Rotator Cuff Repair', 'organization': {'class': 'OTHER', 'fullName': 'La Tour Hospital'}, 'officialTitle': 'Post-operative Mobilisation After Rotator Cuff Repair: Sling Versus Nothing. A Randomized Prospective Study.', 'orgStudyIdInfo': {'id': '2016-00818'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rotator cuff repair with sling', 'description': 'Patients wear a sling during 4 weeks, they also move passively during this period. Then progressive active mobilization is done.', 'interventionNames': ['Procedure: Rotator cuff repair']}, {'type': 'EXPERIMENTAL', 'label': 'Rotator cuff repair without sling', 'description': "Patients don't wear any sling, they move passively in all axes during 4 weeks. Then progressive active mobilization is done.", 'interventionNames': ['Procedure: Rotator cuff repair']}], 'interventions': [{'name': 'Rotator cuff repair', 'type': 'PROCEDURE', 'armGroupLabels': ['Rotator cuff repair with sling', 'Rotator cuff repair without sling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1217', 'city': 'Meyrin', 'state': 'Canton of Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Alexandre Lädermann, MD', 'role': 'CONTACT', 'email': 'alexandre.laedermann@gmail.com', 'phone': '+41227197555'}], 'facility': 'La Tour Hospital', 'geoPoint': {'lat': 46.23424, 'lon': 6.08025}}], 'centralContacts': [{'name': 'Alexandre Lädermann, MD', 'role': 'CONTACT', 'email': 'alexandre.laedermann@gmail.com', 'phone': '227197555', 'phoneExt': '0041'}, {'name': 'Adrien Switzguebel, MD', 'role': 'CONTACT', 'email': 'adrien.schwitzguebel@gmail.com', 'phone': '227197555', 'phoneExt': '0041'}], 'overallOfficials': [{'name': 'Alexandre Lädermann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'La Tour Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'La Tour Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Adrien Schwitzguebel', 'investigatorAffiliation': 'La Tour Hospital'}}}}