Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT00840593
Status:
COMPLETED
Last Update Posted:
2011-12-08
First Post:
2009-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective, Randomised Long-term Follow-up of Operative Versus Non-operative Treatment of Gr. 3 Acromioclavicular Dislocation
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-07', 'studyFirstSubmitDate': '2009-02-09', 'studyFirstSubmitQcDate': '2009-02-09', 'lastUpdatePostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of delayed surgical procedure to treat the AC joint dislocation pathology', 'timeFrame': 'from 18 to 20 years'}], 'secondaryOutcomes': [{'measure': 'Grading of the AC dislocation using Rockwood classification (3-6)', 'timeFrame': '18-20 years'}, {'measure': 'AC joint width in the middle of the joint (mm)', 'timeFrame': '18-20 years'}, {'measure': 'Distance between proc. coracoideus and clavicle (coracoclavicular interspace) in Zanca projection, compared to non-injured side(mm)', 'timeFrame': '18-20 years'}, {'measure': 'Osteolysis of clavicle (none, mild, moderate, severe) for follow-up radiographs', 'timeFrame': '18-20 years'}, {'measure': 'Presence of calcification of CC ligaments (yes/no)', 'timeFrame': '18-20 years'}, {'measure': 'Osteoarthrosis using modified Kellgren-Lawrence classification for follow-up radiographs', 'timeFrame': '18-20 years'}, {'measure': 'Other pathologic condition of the shoulder (eg. osteoarthrosis of the glenohumeral joint, elevation of the humerus, calcific deposits of cuff) and the description of it', 'timeFrame': '18-20 years'}, {'measure': 'The source (mechanism) of the AC dislocation injury (eg. falling, collision', 'timeFrame': '0 day'}, {'measure': 'Patient age at the time of injury (years)', 'timeFrame': '0 day'}, {'measure': 'Patient weight (kg)', 'timeFrame': '18 - 20 years'}, {'measure': 'Patient length (cm)', 'timeFrame': '18 - 20 years'}, {'measure': 'Occupation', 'timeFrame': '18 - 20 years'}, {'measure': 'Grading of the work (light, heavy work, retired)', 'timeFrame': '18 - 20 years'}, {'measure': 'Presence of other pathologic conditions or operative treatments for the shoulder, AC joint or other part of shoulder, description of it', 'timeFrame': '18 - 20 years'}, {'measure': 'Larsen score', 'timeFrame': '18-20 years'}, {'measure': 'Simple Shoulder Test (SST)', 'timeFrame': '18-20 years'}, {'measure': 'UCLA score', 'timeFrame': '18-20 years'}, {'measure': 'Constant score', 'timeFrame': '18-20 years'}, {'measure': 'Oxford score', 'timeFrame': '18-20 years'}, {'measure': 'Instability experiences of the AC joint (none, sometimes = less than 10 times a year, often = more than 10 times year)', 'timeFrame': '18-20 years'}, {'measure': 'Pain (VAS, cm) related to instability experience of AC joint', 'timeFrame': '18-30 years'}, {'measure': 'Range of motion of the shoulder (flexion, abduction, horizontal adduction, degrees', 'timeFrame': '18-20 years'}, {'measure': 'Palpation of the AC joint (normal, prominent but stable, unstable)', 'timeFrame': '18-20 years'}, {'measure': 'Pain of palpation (no or yes)', 'timeFrame': '18-20 years'}, {'measure': 'Cross arm test (pain in AC joint, no/yes)', 'timeFrame': '18-20 years'}, {'measure': 'Other pathologic findings of the shoulder in the clinical examination and the description of it', 'timeFrame': '18-20 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acromioclavicular Joint', 'Dislocation', 'Trials, Randomized Clinical', 'Surgical Procedures, Operative'], 'conditions': ['Acromioclavicular Joint', 'Dislocation', 'Surgical Procedures, Operative']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the long-term clinical and radiological results of operative and conservative treatment of Tossy type 3 acromio-clavicular dislocation.', 'detailedDescription': 'The optimal treatment of Rockwood type 3 AC joint injuries is still controversial. This controversy results from the low level of evidence of the early literature and the evaluation of all AC joint injuries with a type I through III classification system.\n\nThere are no prospective randomized controlled long-term studies on the treatment of Tossy type 3 AC dislocation using primary repair and minimal pin fixation.\n\nIn this study, the non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The surgical treatment consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with Tossy grade 3 AC-dislocation was recruited between the years 1989 and 1991 at Kuopio University Hospital for a randomized controlled study\n* A written informed consent.\n\nExclusion Criteria:\n\n* Not written informed consent'}, 'identificationModule': {'nctId': 'NCT00840593', 'briefTitle': 'A Prospective, Randomised Long-term Follow-up of Operative Versus Non-operative Treatment of Gr. 3 Acromioclavicular Dislocation', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'A Prospective, Randomised 18 -Year Follow-up Study of Operative and Non-operative Treatment of Acute, Total Acromioclavicular Dislocation.', 'orgStudyIdInfo': {'id': 'KUH5203037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1. Non-surgical group', 'description': 'The non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The patient was encouraged in mobilisation of the elbow several times per day and the mobilisation of the shoulder with pendulum type movements were initiated four weeks after the injury. Active mobilisation of the shoulder was allowed six weeks after the injury.', 'interventionNames': ['Procedure: Non-surgical group']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 Surgical group', 'description': 'The surgical treatment was accomplished within two days after the injury, and it consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament. The position of Kirschner wires was confirmed during the operation using C-arm transillumination. The articular disc of AC joint was removed if it was damaged. Postoperative care consisted of immobilisation of the AC joint in a sling, (Polysling, body band) for four weeks and the mobilisation of the shoulder started four to six weeks later in a similar manner as in the non-operative group.', 'interventionNames': ['Procedure: Surgical group']}], 'interventions': [{'name': 'Non-surgical group', 'type': 'PROCEDURE', 'description': 'The non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The patient was encouraged in mobilisation of the elbow several times per day and the mobilisation of the shoulder with pendulum type movements were initiated four weeks after the injury. Active mobilisation of the shoulder was allowed six weeks after the injury.', 'armGroupLabels': ['1. Non-surgical group']}, {'name': 'Surgical group', 'type': 'PROCEDURE', 'description': 'The surgical treatment was accomplished within two days after the injury, and it consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament. The position of Kirschner wires was confirmed during the operation using C-arm transillumination. The articular disc of AC joint was removed if it was damaged. Postoperative care consisted of immobilisation of the AC joint in a sling, (Polysling, body band) for four weeks and the mobilisation of the shoulder started four to six weeks later in a similar manner as in the non-operative group.', 'armGroupLabels': ['2 Surgical group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70211', 'city': 'Kuopio', 'state': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Antti Joukainen', 'investigatorAffiliation': 'Kuopio University Hospital'}}}}