Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-28 @ 11:12 PM
Study NCT ID:
NCT00891566
Status:
COMPLETED
Last Update Posted:
2011-05-24
First Post:
2009-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007103', 'term': 'Immobilization'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-23', 'studyFirstSubmitDate': '2009-04-29', 'studyFirstSubmitQcDate': '2009-04-30', 'lastUpdatePostDateStruct': {'date': '2011-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'repair integrity analysis using postoperative MRI', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': "American Shoulder and Elbow Surgeons' score", 'timeFrame': '2 year postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['medium to large tear', 'rotator cuff tear', 'arthroscopic repair', 'repair integrity', 'immobilization'], 'conditions': ['Rotator Cuff Tear']}, 'referencesModule': {'references': [{'pmid': '16607589', 'type': 'RESULT', 'citation': 'Pennekamp W, Gekle C, Nicolas V, Seybold D. [Initial results of shoulder MRI in external rotation after primary shoulder dislocation and after immobilization in external rotation]. Rofo. 2006 Apr;178(4):410-5. doi: 10.1055/s-2006-926476. German.'}, {'pmid': '11347400', 'type': 'RESULT', 'citation': 'Lewis CW, Schlegel TF, Hawkins RJ, James SP, Turner AS. The effect of immobilization on rotator cuff healing using modified Mason-Allen stitches: a biomechanical study in sheep. Biomed Sci Instrum. 2001;37:263-8.'}, {'pmid': '16012501', 'type': 'RESULT', 'citation': 'Kim SH, Yoo JC, Ahn JM. Arthroscopically repaired Bankart lesions and the effect of two different arm positions on immediate postoperative evaluation with magnetic resonance arthrography. Arthroscopy. 2005 Jul;21(7):867-74. doi: 10.1016/j.arthro.2005.04.109.'}, {'pmid': '24647511', 'type': 'DERIVED', 'citation': 'Koh KH, Lim TK, Shon MS, Park YE, Lee SW, Yoo JC. Effect of immobilization without passive exercise after rotator cuff repair: randomized clinical trial comparing four and eight weeks of immobilization. J Bone Joint Surg Am. 2014 Mar 19;96(6):e44. doi: 10.2106/JBJS.L.01741.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the immobilization period is helpful for the better healing of repaired rotator cuff.\n\nThe investigators hypothesis is that the longer immobilization after rotator cuff repair will help the healing of rotator cuff.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'medium to large size rotator cuff tears', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medium to large sized cuff tear (2-4 cm)\n* Yes subscapular partial fraying or longitudinal split side to side\n* Yes acromioplasty\n* Yes AC arthritis with mumford procedure\n* Yes biceps tenotomy or tenodesis\n\nExclusion Criteria:\n\n* No arthritic changes of glenohumeral joint\n* No combined infection\n* No mini-open procedures\n* No complete subscapularis tear\n* No incomplete repair\n* No small tears or side to side repairs without anchors\n* No pregnancy'}, 'identificationModule': {'nctId': 'NCT00891566', 'briefTitle': 'Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Prolonged Versus Conventional Immobilization After Arthroscopic Repair for Medium to Large Size Rotator Cuff Tear. A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2008-04-051'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Immobilization', 'type': 'PROCEDURE', 'description': 'compared the healing status for 8 weeks of immobilization with the conventional 4 weeks of immobilization after rotator cuff repair'}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jae Chul Yoo', 'oldOrganization': 'Samsung Medical Center'}}}}