Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT03885856
Status:
COMPLETED
Last Update Posted:
2020-03-12
First Post:
2019-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-11', 'studyFirstSubmitDate': '2019-03-19', 'studyFirstSubmitQcDate': '2019-03-21', 'lastUpdatePostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in The American Shoulder and Elbow Surgeons Shoulder Score (ASES)', 'timeFrame': 'At six months and one year follow up after surgery', 'description': 'The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain ( Visual Analogue Scale ranging from 0 = "no pain at all" to 10 = "pain as bad as it can be"), instability, and activities of daily living (ranging from "unable to do" to " not difficult"). The pain and functional portions are summed to obtain the final ASES score with higher scores indicating better outcomes.'}, {'measure': 'Pain at rest (yes/no)', 'timeFrame': 'At six months after surgery', 'description': 'Pain at rest (yes/no)'}, {'measure': 'Change in Constant-Murley score (CMS)', 'timeFrame': 'At six months and one year follow up after surgery', 'description': 'Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function'}, {'measure': 'Pain at rest (yes/no)', 'timeFrame': 'At one year follow up after surgery', 'description': 'Pain at rest (yes/no)'}, {'measure': 'Pain under stress (yes/no)', 'timeFrame': 'At six months after surgery', 'description': 'Pain under stress (yes/no)'}, {'measure': 'Pain under stress (yes/no)', 'timeFrame': 'At one year follow up after surgery', 'description': 'Pain under stress (yes/no)'}, {'measure': 'Number of Reoperations (quantity)', 'timeFrame': 'Summarized over a one year follow up period after surgery', 'description': 'Number of Reoperations (quantity)'}, {'measure': 'Number of Rehospitalizations (quantity)', 'timeFrame': 'Summarized over a one year follow up period after surgery', 'description': 'Number of Rehospitalizations (quantity)'}], 'primaryOutcomes': [{'measure': 'Radiologic assessment of surgical treatment of rotator cuff tear', 'timeFrame': 'directly postoperative (within 24 hours after surgery)', 'description': 'X-ray shoulder for assessment of acromiohumeral space and morphology (Millimeters)'}, {'measure': 'Magnetic resonance imaging (MRI) of surgical treatment of rotator cuff tear', 'timeFrame': 'directly postoperative (within 24 hours after surgery)', 'description': 'MRI shoulder to asses morphology of shoulder'}, {'measure': 'Ultrasonography of surgical treatment of rotator cuff tear', 'timeFrame': 'From 6 months up to 1 year postoperative', 'description': 'Ultrasonography to evaluate the healing of the tendon at the bone interface and degree of gap Formation (degree)'}], 'secondaryOutcomes': [{'measure': 'Active range of motion', 'timeFrame': 'At six months and one year follow up after surgery', 'description': 'Active range of motion of shoulder (degrees)'}, {'measure': 'Passive range of motion', 'timeFrame': 'At six months and one year follow up after surgery', 'description': 'Passive range of motion of shoulder (degrees)'}, {'measure': 'Use of analgesics', 'timeFrame': 'At six months after surgery', 'description': 'Use of analgesics (yes/no)'}, {'measure': 'Use of analgesics', 'timeFrame': 'At one year follow up after surgery', 'description': 'Use of analgesics (yes/no)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rotator cuff repair', 'rotator cuff tear', 'single row repair technique', 'double row repair technique'], 'conditions': ['Rotator Cuff Injury']}, 'descriptionModule': {'briefSummary': "This study is to analyse whether there is a difference in clinical and radiological outcomes between single row and double row repair techniques for the treatment of shoulder's rotator cuff tears.", 'detailedDescription': "A tear of the rotator cuff is one of the most common disorders of the shoulder and can have a significant effect on daily activities as a result of a loss of motion and strength. The goal of rotator cuff repair is to treat the patient's current clinical symptoms and improve shoulder function and to prevent the long-term consequences of rotator cuff arthropathy. This project aims at a retrospective analysis of preexisting risk factors for sustaining rotator cuff injury as well as for failing to reach the previous functional level, used surgical technique -either single row repair or double row repair- and its significance for the functional outcome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated for rotator cuff lesion either traumatic or degenerative at the University Hospital Basel and Kantonsspital BaselLand between 01.01.2015 and 30.1.2018', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Treated by single row or double row repair technique for shoulder's rotator cuff tears\n* Time lapse from injury to surgery ranges from one day to less than 1 year\n* Availability of clinical and radiological outcomes from 6 months to 1 year follow up\n\nExclusion Criteria:\n\n* Massive irreparable tear\n* Patient has frozen shoulder\n* Chronically retracted tendons and atrophic rotator cuff muscles"}, 'identificationModule': {'nctId': 'NCT03885856', 'acronym': 'RCR', 'briefTitle': 'Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row Rotator Cuff Repair', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row Rotator Cuff Repair; a Comparative Study', 'orgStudyIdInfo': {'id': '2019-00339; ch19Taha'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single row repair technique', 'description': 'patients surgically treated for rotator cuff lesion by single row repair technique', 'interventionNames': ['Other: single row repair technique']}, {'label': 'double row repair technique', 'description': 'patients surgically treated for rotator cuff lesion by double row repair technique', 'interventionNames': ['Other: double row repair technique']}], 'interventions': [{'name': 'single row repair technique', 'type': 'OTHER', 'description': 'single row repair technique', 'armGroupLabels': ['single row repair technique']}, {'name': 'double row repair technique', 'type': 'OTHER', 'description': 'double row repair technique', 'armGroupLabels': ['double row repair technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Department of Orthopaedics', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Mohy Taha, Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopaedics and Traumatology, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}