Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-31 @ 1:10 PM
Study NCT ID:
NCT02628457
Status:
UNKNOWN
Last Update Posted:
2015-12-11
First Post:
2015-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Did MRI Appearance of Supraspinatus Muscle Atrophy Changes After Repair of All Kind of Rotator Cuff Tear?
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': 209}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2015-12-03', 'studyFirstSubmitQcDate': '2015-12-10', 'lastUpdatePostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in supraspinatus muscle atrophy', 'timeFrame': 'within 1 week after surgery', 'description': 'Supraspinatus muscle atrophy was measured and evaluated according to the Thomazeau classification. Stage 1: slight atrophy occupation ratio (1.00-0.60), Stage 2: moderate atrophy occupation ratio (0.60-0.40), Stage 3: Severe atrophy occupation ratio(\\<0.40). Both preoperative and immediate postoperative occupancy ratio calculated and from that change in occupancy ratio calculated for each and every patient.Postoperative occupation ratio was compared with preoperative occupation ratio within the groups and change in occupation ratio was used for comparison between the groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['occupation ratio', 'pseudoatrophy'], 'conditions': ['Rotator Cuff Tear']}, 'descriptionModule': {'briefSummary': 'There are two purpose of this study, first is to find whether arthroscopic rotator cuff repair is changing the appearance of supraspinatus muscle atrophy in each and every patient. Second, is to find how much approximate change one can expect depending on age and tendon retraction', 'detailedDescription': 'Retrospective review of 209 patients having both preoperative and immediate postoperative MRI done. Both preoperative and immediate postoperative occupancy ratio calculated and from that change in occupancy ratio calculated for each and every patient. Patient were divided in two major group according to age that is \\<60 years and \\>60 years and 3 subgroups of mild, moderate and severe depending on preoperative supraspinatus tendon retraction on coronal view of MRI. Postoperative occupation ratio was compared with preoperative occupation ratio within the subgroups and change in occupation ratio was used for comparison between the subgroup. Change in occupation ratio was also used for comparison between 2 major groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '209 patients with degenerative rotator cuff tear who underwent single-row arthroscopic rotator cuff repair between March 2012 and April 2015 in CM hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with degenerative rotator cuff tear who underwent single-row arthroscopic rotator cuff repair in our hospital.\n2. Patients with preoperative MRI and postoperative MRI within 1 week of surgery in our hospital.\n3. Patients with minimum grade 1 supraspinatus atrophy in preoperative MRI.\n\nExclusion Criteria:\n\n1. Patients with preoperative MRI from outside hospital.\n2. Patients with isolated subscapularis tear.\n3. Patients with previous operation on the same shoulder joint.\n4. Patients with MRI images that were not usable due to poor quality or absence of appropriate Y-view.'}, 'identificationModule': {'nctId': 'NCT02628457', 'briefTitle': 'Did MRI Appearance of Supraspinatus Muscle Atrophy Changes After Repair of All Kind of Rotator Cuff Tear?', 'organization': {'class': 'OTHER', 'fullName': 'CM Chungmu Hospital'}, 'officialTitle': 'Did MRI Appearance of Supraspinatus Muscle Atrophy Changes After Repair of All Kind of Rotator Cuff Tear?', 'orgStudyIdInfo': {'id': 'CMH-2015-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild Subgroup', 'description': 'patients with supraspinatus tendon retracted upto medial 1/3rd of humerus head and arthroscopic rotator cuff repair done by single row.', 'interventionNames': ['Procedure: arthroscopic rotator cuff repair']}, {'label': 'Moderate Subgroup', 'description': 'patients with supraspinatus tendon retracted between medial 1/3rd of humerus head and glenoid,and arthroscopic rotator cuff repair done by single row.', 'interventionNames': ['Procedure: arthroscopic rotator cuff repair']}, {'label': 'Severe subgroup', 'description': 'patients with supraspinatus tendon retracted beyond glenoid and arthroscopic rotator cuff repair done by single row', 'interventionNames': ['Procedure: arthroscopic rotator cuff repair']}], 'interventions': [{'name': 'arthroscopic rotator cuff repair', 'type': 'PROCEDURE', 'description': 'arthroscopic rotator cuff repair done in all patients to check whether, surgery itself changes the appearance of muscle atrophy in the supraspinatus in all patients irrespective of size of preoperative tendon retraction', 'armGroupLabels': ['Mild Subgroup', 'Moderate Subgroup', 'Severe subgroup']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yeongdeungpo-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Chungmu General Hopsital', 'geoPoint': {'lat': 37.51528, 'lon': 126.88722}}], 'overallOfficials': [{'name': 'sang-Hoon Lhee, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'President, CM general Hospital'}, {'name': 'Anant kumar Singh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'arthroscopy fellow, CM general Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing of data on the website is against the policy of IRB Korea'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CM Chungmu Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}