Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-30 @ 2:01 AM
Study NCT ID:
NCT01110304
Status:
UNKNOWN
Last Update Posted:
2012-12-20
First Post:
2010-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acromio-clavicular Dislocation Type III - Conservative Treatment Versus Surgical Hook Plate Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004204', 'term': 'Joint Dislocations'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001915', 'term': 'Braces'}, {'id': 'D000700', 'term': 'Analgesics'}], 'ancestors': [{'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-19', 'studyFirstSubmitDate': '2010-04-21', 'studyFirstSubmitQcDate': '2010-04-23', 'lastUpdatePostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional results of injured shoulder on Constant score', 'timeFrame': '3 months after surgery', 'description': "Based on the patient's subjective and objective answers to the Constant and Murley questionnaire, data are collected and calculated over a 100 points to measure the functional score of the injured shoulder.\n\nAlso, to measure shoulder strength, the Isoforce system from MDS® is used."}], 'secondaryOutcomes': [{'measure': 'Return to professional activities', 'timeFrame': '3 months after surgery', 'description': "Evaluation of the patient's capacity to return to work and evaluating if those treated surgically return to work faster than the patients with a conservative treatment."}, {'measure': 'Rate of secondary surgery', 'timeFrame': 'up to 12 months after surgery', 'description': 'The difference on the reoperation rate between the two groups will be analyzed.'}, {'measure': 'Social impact on SF-36 scale', 'timeFrame': '3 months after surgery', 'description': 'The social impact of both treatments will be measured with the SF-36 score.'}, {'measure': 'Functional difference', 'timeFrame': '6 months after surgery', 'description': 'Using the Constant score, the functional difference between the two groups at 6 months will be measured.'}, {'measure': 'Social impact on SF-36 scale', 'timeFrame': '6 months after surgery', 'description': 'The social impact of both treatments will be measured with the SF-36 score.'}, {'measure': 'Social impact on SF-36 scale', 'timeFrame': '12 months after surgery', 'description': 'The social impact of both treatments will be measured with the SF-36 score.'}, {'measure': 'Radiologic assessment on the Zanca and axillary views', 'timeFrame': '6 weeks after surgery', 'description': 'Zanca view allows control of the superior displacement. It will be expressed in percentage of the CC distance compared to the non-injured side.\n\nAxillary view allows control of the posterior displacement. It will be expressed in percentage of the AC distance compared to the non-injured side.\n\nBoth views will assess degenerative changes, subacromial osteolysis, distal clavicle osteolysis (all expressed in percentage of patients per group).'}, {'measure': 'Rate of complications', 'timeFrame': 'up to 12 months after surgery', 'description': 'The rate of complications both general and orthopaedic will be described in the in percentage of the number of patients per group.'}, {'measure': 'Pain on Visual analog scale (VAS)', 'timeFrame': '6 weeks after surgery', 'description': 'Pain is described with the VAS, which range from 1 to 10.'}, {'measure': 'Pain on VAS', 'timeFrame': '3 months after surgery', 'description': 'Pain is described with the VAS, which range from 1 to 10.'}, {'measure': 'Pain on VAS', 'timeFrame': '6 months after surgery', 'description': 'Pain is described with the VAS, which range from 1 to 10.'}, {'measure': 'Pain on VAS', 'timeFrame': '12 months after surgery', 'description': 'Pain is described with the VAS, which range from 1 to 10.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acromio-clavicular joint dislocation', 'type III acromio-clavicular joint dislocation', 'joint dislocation', 'clavicle hook plate'], 'conditions': ['Acromio-clavicular Joint Dislocation (Type III)']}, 'descriptionModule': {'briefSummary': 'Acromio-clavicular (AC) joint dislocation corresponds to 8.6% of all joint dislocations and represents a major injury to the shoulder girdle. The nature of the treatment is decided according to the severity of the lesion.\n\nThe purpose of this study is to determine whether the surgical treatment is required or not for type III AC joint dislocations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men or women ≥ 18 years-old;\n* AC joint dislocation type III with Zanca X-ray view demonstrating CC distance of 200%;\n* trauma-surgery delay of less than 14 days;\n* consent form signed.\n\nExclusion Criteria:\n\n* AC joint dislocation type I, II, IV, V or VI;\n* associated neuro-vascular damage;\n* men or women \\> 60 years-old;\n* open dislocation;\n* local skin damage;\n* dislocation in a polytrauma patient;\n* floating shoulder;\n* fracture of the ipsilateral or controlateral arm or shoulder girdle;\n* fracture of the coracoid process of the scapula;\n* history of previous surgery to the shoulder;\n* medical condition preventing surgery;\n* men or women unfit to consent;\n* any other condition that make the examinator thinks that the follow up would be problematic.'}, 'identificationModule': {'nctId': 'NCT01110304', 'briefTitle': 'Acromio-clavicular Dislocation Type III - Conservative Treatment Versus Surgical Hook Plate Treatment', 'organization': {'class': 'OTHER', 'fullName': "Hopital de l'Enfant-Jesus"}, 'officialTitle': 'Acromio-clavicular Joint Dislocation Type III. Conservative Treatment Compared to Surgical Management With 3.5mm Clavicle Hook Plate. A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'PEJ-337'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative treatment', 'description': 'Patients selected for this treatment will wear a light brace for pain release and analgesics will be prescribed.', 'interventionNames': ['Other: Conservative treatment - brace']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical treatment', 'description': 'Patients will undergo surgery to treat their AC joint dislocation.', 'interventionNames': ['Device: Hook plate by Synthes']}], 'interventions': [{'name': 'Conservative treatment - brace', 'type': 'OTHER', 'otherNames': ['brace and analgesics'], 'description': 'Patients selected for this treatment will wear a light brace for pain release and analgesics will be prescribed. They can move the elbow, the wrist and the fingers immediately. After two weeks, they will begin a training program to restore shoulder motion and strength, and they will be asked to take off the brace progressively. They are allowed to start working and sporting activities when they feel comfortable.', 'armGroupLabels': ['Conservative treatment']}, {'name': 'Hook plate by Synthes', 'type': 'DEVICE', 'otherNames': ['hook plate surgery'], 'description': 'The patient is in a beach-chair position with injured arm slightly out of the table, on a bracket. The incision is longitudinal, from the distal third of the clavicle to the lateral border of the acromion. The deltoid is detached anteriorly to present the clavicle and the AC joint. The width of the hook depends on the depth of the acromion. The plate will always be 5 holes 3.5mm hook plate (Synthes®), left or right. The hook is inserted after visual reduction of the AC joint at the posterior border of the distal end of the clavicle, under the acromion. Reduction is then maintained by a davier and fixation with three 3,5mm cortical screws is achieved. After washing, deltoid is reinserted. CC ligaments are not directly repaired. Wound closure and bracing for two weeks.', 'armGroupLabels': ['Surgical treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1J 1Z4', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Stéphane Pelet, MD, PhD', 'role': 'CONTACT', 'email': 'stephane.pelet.ortho@gmail.com', 'phone': '418-649-0252', 'phoneExt': '3165'}, {'name': 'Stéphane Pelet, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHA-Pavillon Enfant-Jésus', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Hélène Côté, Reg. Nurse', 'role': 'CONTACT', 'email': 'helco3@hotmail.com', 'phone': '418-649-0252', 'phoneExt': '3165'}, {'name': 'Stéphane Pelet, MD, PhD', 'role': 'CONTACT', 'email': 'stephane.pelet.ortho@gmail.com', 'phone': '418-649-0252', 'phoneExt': '3165'}], 'overallOfficials': [{'name': 'Stéphane Pelet, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Enfant-Jésus'}, {'name': 'Karine Sinclair, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Enfant-Jésus'}, {'name': 'Luc Bédard, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Enfant-Jésus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hopital de l'Enfant-Jesus", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Stephane Pelet MD, PhD Orthopedic surgeon', 'investigatorFullName': 'Pelet Stephane', 'investigatorAffiliation': "Hopital de l'Enfant-Jesus"}}}}