Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT01585467
Status:
COMPLETED
Last Update Posted:
2015-05-07
First Post:
2012-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Shoulder Dislocation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012783', 'term': 'Shoulder Dislocation'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], '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'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2012-04-24', 'studyFirstSubmitQcDate': '2012-04-24', 'lastUpdatePostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prospective validation of clinical decision rules', 'timeFrame': 'to be measured at study conclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anterior Shoulder Dislocation', 'Shoulder Dislocation', 'Shoulder Pain', 'Shoulder Deformity'], 'conditions': ['Shoulder Dislocation']}, 'referencesModule': {'references': [{'pmid': '8114236', 'type': 'BACKGROUND', 'citation': 'Stiell IG, McKnight RD, Greenberg GH, McDowell I, Nair RC, Wells GA, Johns C, Worthington JR. Implementation of the Ottawa ankle rules. JAMA. 1994 Mar 16;271(11):827-32.'}, {'pmid': '8433468', 'type': 'BACKGROUND', 'citation': 'Stiell IG, Greenberg GH, McKnight RD, Nair RC, McDowell I, Reardon M, Stewart JP, Maloney J. Decision rules for the use of radiography in acute ankle injuries. Refinement and prospective validation. JAMA. 1993 Mar 3;269(9):1127-32. doi: 10.1001/jama.269.9.1127.'}, {'pmid': '11597285', 'type': 'BACKGROUND', 'citation': 'Stiell IG, Wells GA, Vandemheen KL, Clement CM, Lesiuk H, De Maio VJ, Laupacis A, Schull M, McKnight RD, Verbeek R, Brison R, Cass D, Dreyer J, Eisenhauer MA, Greenberg GH, MacPhail I, Morrison L, Reardon M, Worthington J. The Canadian C-spine rule for radiography in alert and stable trauma patients. JAMA. 2001 Oct 17;286(15):1841-8. doi: 10.1001/jama.286.15.1841.'}, {'pmid': '8594242', 'type': 'BACKGROUND', 'citation': 'Stiell IG, Greenberg GH, Wells GA, McDowell I, Cwinn AA, Smith NA, Cacciotti TF, Sivilotti ML. Prospective validation of a decision rule for the use of radiography in acute knee injuries. JAMA. 1996 Feb 28;275(8):611-5.'}, {'pmid': '10891516', 'type': 'BACKGROUND', 'citation': 'Hoffman JR, Mower WR, Wolfson AB, Todd KH, Zucker MI. Validity of a set of clinical criteria to rule out injury to the cervical spine in patients with blunt trauma. National Emergency X-Radiography Utilization Study Group. N Engl J Med. 2000 Jul 13;343(2):94-9. doi: 10.1056/NEJM200007133430203.'}, {'pmid': '8839524', 'type': 'BACKGROUND', 'citation': 'Hendey GW, Kinlaw K. Clinically significant abnormalities in postreduction radiographs after anterior shoulder dislocation. Ann Emerg Med. 1996 Oct;28(4):399-402. doi: 10.1016/s0196-0644(96)70004-5.'}, {'pmid': '10918101', 'type': 'BACKGROUND', 'citation': 'Hendey GW. Necessity of radiographs in the emergency department management of shoulder dislocations. Ann Emerg Med. 2000 Aug;36(2):108-113. doi: 10.1067/mem.2000.108314.'}, {'pmid': '16798149', 'type': 'BACKGROUND', 'citation': 'Hendey GW, Chally MK, Stewart VB. Selective radiography in 100 patients with suspected shoulder dislocation. J Emerg Med. 2006 Jul;31(1):23-8. doi: 10.1016/j.jemermed.2005.09.006.'}, {'pmid': '19166638', 'type': 'BACKGROUND', 'citation': 'Emond M, Le Sage N, Lavoie A, Moore L. Refinement of the Quebec decision rule for radiography in shoulder dislocation. CJEM. 2009 Jan;11(1):36-43. doi: 10.1017/s1481803500010903.'}, {'pmid': '15289192', 'type': 'BACKGROUND', 'citation': 'Emond M, Le Sage N, Lavoie A, Rochette L. Clinical factors predicting fractures associated with an anterior shoulder dislocation. Acad Emerg Med. 2004 Aug;11(8):853-8. doi: 10.1111/j.1553-2712.2004.tb00768.x.'}]}, 'descriptionModule': {'briefSummary': 'To compare and validate the two clinical algorithms', 'detailedDescription': 'Clinical Decision rules have safely and successfully allowed clinicians to reduce the total number of radiographs ordered, while detecting patients with important pathology or injuries. The Ottawa Ankle and Knee Rules were developed from a series of studies, and have successfully reduced the number of radiographs ordered by physicians without missing serious ankle fractures (1-4). Likewise, the NEXUS group developed a clinical decision rule for the selection of blunt trauma patients who are appropriate for imaging, based on clinical features (5).\n\nDrs. Hendey and Emond have separately developed similar algorithms for selective radiography in patients with a suspected shoulder dislocation (6-10). The goal of the current study is to compare and validate the two clinical algorithms.\n\nBoth approaches examine clinical features that are readily accessible to the physician at the time of ED evaluation. In the pre-reduction assessment, both algorithms included the mechanism of injury and whether the patient had experienced a previous shoulder dislocation. Hendey additionally assessed whether the physician was clinically confident of the dislocation (8). Emond additionally included the age of the patient, and the presence or absence of humeral ecchymosis (9). In the post-reduction assessment, both algorithms emphasize the importance of clinical certainty of reduction, as well as the presence of a fracture dislocation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients 18 years and older\n* patient with a suspected acute anterior shoulder dislocation\n\nExclusion Criteria:\n\n* patients under 18 years of age\n* prisoners'}, 'identificationModule': {'nctId': 'NCT01585467', 'briefTitle': 'Anterior Shoulder Dislocation', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Selective Radiography in Anterior Shoulder Dislocation: Prospective Validation Rule of Decision Rules Derived in Fresno and Quebec', 'orgStudyIdInfo': {'id': '02102010'}}, 'contactsLocationsModule': {'locations': [{'zip': '93701', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco-Fresno', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': 'G1V 0A6', 'city': 'Qubec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Universite Laval Pavillon Ferdinand-Vandry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}