Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-28 @ 3:32 PM
Study NCT ID:
NCT01829633
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2013-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2013-04-09', 'studyFirstSubmitQcDate': '2013-04-09', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder sonography', 'timeFrame': 'Baseline to 8-10 years follow-up', 'description': 'Sonographic shoulder examination was performed for all study patients before treatment was given. All patients will be reexamined by sonography after 8 to 10 years. The finding of interest is the change of tear size as determined by sonography'}], 'secondaryOutcomes': [{'measure': 'Number of relapses during follow-up', 'timeFrame': '8 to 10 years', 'description': 'At follow-up patients have to report how many new periods with shoulder pain they have experienced since the time of diagnosis'}, {'measure': 'Number of patients who needed surgical treatment of their shoulder during follow-up', 'timeFrame': '8 to 10 years', 'description': 'At follow-up, patients have to report the number of surgical interventions in their study shoulder since the time of diagnosis.'}, {'measure': 'MRI of the shoulder', 'timeFrame': 'MRI will be performed at 8 to 10 years follow-up', 'description': 'At the time of diagnosis, no patient had serious muscle atrophy or fatty degeneration as determined by MRI. The finding of interest at 8 to 10 years follow-up is the number of patients who have progressed to serious muscle atrophy or fatty degeneration during follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Full-thickness Rotator Cuff Tears']}, 'referencesModule': {'references': [{'pmid': '28089257', 'type': 'RESULT', 'citation': 'Moosmayer S, Gartner AV, Tariq R. The natural course of nonoperatively treated rotator cuff tears: an 8.8-year follow-up of tear anatomy and clinical outcome in 49 patients. J Shoulder Elbow Surg. 2017 Apr;26(4):627-634. doi: 10.1016/j.jse.2016.10.002. Epub 2017 Jan 12.'}]}, 'descriptionModule': {'briefSummary': 'Study population: Patients who have been treated with physiotherapy for a potentially repairable rotator cuff tear in the period from 2002 to 2005.\n\nStudy Method: At the time of diagnosis (2002 to 2005) all study patients were examined clinically, sonographically and by MRI. Some patients also completed a shoulder score. All study patients will now be reexamined, 8 to 10 years after they were diagnosed. Reexamination includes history taking, clinical examination, completion of three shoulder scores (two shoulder specific scores, one general health score), Sonography and MRI. Findings of interest are\n\n* the number of relapses during follow-up,\n* the need for surgical treatment during follow-up,\n* the deterioration of tear anatomy (tear size, muscle atrophy, fatty degeneration) during follow-up\n* the actual clinical shoulder condition (as given by shoulder scores) at reexamination.\n\nStudy purpose: We want to assess the anatomic and clinical long-term results of physiotherapy for potentially repairable rotator cuff tears. We want to find out if tear anatomy of unrepaired rotator cuff tears deteriorates over time and if such a deterioration is associated with a development of more serious degrees of symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with a symptomatic full-thickness rotator cuff tear in the period 2002 to 2005. All tears were deemed to be repairable at the time of the diagnosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full-thickness rotator cuff tear diagnosed between 2002 and 2005 by both sonography and MRI.\n\nAt the time of diagnosis (2002 to 2005):\n\n* Typical clinical symptoms for a rotator cuff tear including pain laterally on upper humerus, painful arc, positive impingement test (Neer or Hawkins)\n* Potentially repairable tear (tear size up to 3 cm, muscle atrophy not exceeding grade 2 according to Thomazeau, fatty degeneration not exceeding grade 1 according to Goutallier).\n* Treated by physiotherapy for at least 3 months\n\nExclusion Criteria:\n\nAt the time of diagnosis (2002 to 2005):\n\n* Full-thickness tears of the subscapularis tendon or of the entire supraspinatus and infraspinatus tendons\n* Other symptomatic shoulder pathology including long head of the biceps tendon pathology, acromioclavicular joint pathology, shoulder instability, inflammatory diseases, glenohumeral arthritis\n* Earlier treated with rotator cuff repair in the study shoulder'}, 'identificationModule': {'nctId': 'NCT01829633', 'briefTitle': 'Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears', 'organization': {'class': 'OTHER', 'fullName': 'Vestre Viken Hospital Trust'}, 'officialTitle': 'Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears', 'orgStudyIdInfo': {'id': '29144/3/LT'}, 'secondaryIdInfos': [{'id': '2011/1931', 'type': 'OTHER', 'domain': 'Regional Committees for Medical and Health Research Ethics'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rotator cuff tears', 'description': 'Patients who were diagnosed with a symptomatic full-thickness tear of the rotator cuff. Tear examination by sonography and MRI showed a repairable tear. All patients were initially treated conservatively by physiotherapy.', 'interventionNames': ['Procedure: Physiotherapy']}], 'interventions': [{'name': 'Physiotherapy', 'type': 'PROCEDURE', 'description': 'Shoulder physiotherapy with exercises', 'armGroupLabels': ['Rotator cuff tears']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1306', 'city': 'Sandvika', 'country': 'Norway', 'facility': "Martina Hansen's Hospital", 'geoPoint': {'lat': 64.46377, 'lon': 13.59125}}], 'overallOfficials': [{'name': 'Stefan Moosmayer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vestre Viken Hospital Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vestre Viken Hospital Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Stefan Moosmayer', 'investigatorAffiliation': 'Vestre Viken Hospital Trust'}}}}