Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT00707018
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2008-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immobilization in External Rotation After First Time Anterior Shoulder Dislocation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012783', 'term': 'Shoulder Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2008-06-26', 'studyFirstSubmitQcDate': '2008-06-27', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation.', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Patient self reported outcome measures', 'timeFrame': '24 Months'}, {'measure': 'Time to return to work or sport', 'timeFrame': '24 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Dislocation']}, 'descriptionModule': {'briefSummary': 'Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.', 'detailedDescription': 'The purpose of this study is to compare immobilization in internal versus external rotation after first time anterior shoulder dislocation, and thereby increase our knowledge about the best standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 14 to 30 years of age\n* Willing to participate in follow-up for at least two years\n* Acute, first-time, traumatic, isolated anterior dislocation of the shoulder\n\nExclusion Criteria:\n\n* Previous instability of the affected shoulder\n* A history of significant ligamentous laxity or demonstrated multi-directional instability of the opposite shoulder\n* Inability or unwillingness to comply with sling immobilization, rehabilitative protocol, or required follow-up assessments\n* Incompetent or unwilling to consent\n* A medical condition making the patient unable to wear a sling\n* Significant associated fracture (Exception Hill Sachs of \\>20% or bony Bankart lesions\\>10%)\n* Neurovascular compromise of the affected limb\n* Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program."}, 'identificationModule': {'nctId': 'NCT00707018', 'briefTitle': 'Immobilization in External Rotation After First Time Anterior Shoulder Dislocation', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Immobilization in External Rotation After First Time Anterior Shoulder Dislocation: A Prospective Randomized Study', 'orgStudyIdInfo': {'id': '04-0088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'External rotation shoulder sling', 'description': 'External rotation shoulder sling', 'interventionNames': ['Device: External rotation shoulder sling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Internal rotation shoulder sling', 'description': 'Internal rotation shoulder sling', 'interventionNames': ['Device: Internal rotation shoulder sling']}], 'interventions': [{'name': 'External rotation shoulder sling', 'type': 'DEVICE', 'description': 'The external rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 10 to 15 degrees of external rotation at the shoulder.', 'armGroupLabels': ['External rotation shoulder sling']}, {'name': 'Internal rotation shoulder sling', 'type': 'DEVICE', 'description': 'The internal rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 70 to 80 degrees of internal rotation at the shoulder.', 'armGroupLabels': ['Internal rotation shoulder sling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80304', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'CU Sports Medicine', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80482', 'city': 'Winter Park', 'state': 'Colorado', 'country': 'United States', 'facility': 'St. Anthony Hospitals', 'geoPoint': {'lat': 39.89165, 'lon': -105.76306}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '44310', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Summa Healthcare', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '99163', 'city': 'Pullman', 'state': 'Washington', 'country': 'United States', 'facility': 'Inland Orthopaedics', 'geoPoint': {'lat': 46.73127, 'lon': -117.17962}}], 'overallOfficials': [{'name': 'Eric C McCarty, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}