Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-04-16 @ 5:26 PM
Study NCT ID:
NCT02256059
Status:
COMPLETED
Last Update Posted:
2014-10-03
First Post:
2014-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D018460', 'term': 'Fractures, Comminuted'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-30', 'studyFirstSubmitDate': '2014-09-28', 'studyFirstSubmitQcDate': '2014-09-30', 'lastUpdatePostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone healing', 'timeFrame': '12 month', 'description': 'time until bone healing, visualized using conventional x-ray in two planes'}], 'secondaryOutcomes': [{'measure': 'shoulder function', 'timeFrame': '12 month', 'description': 'shoulder function assessed using Munich Shoulder Questionnaire \\[MSQ\\]'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fracture, Closed, Comminuted, Healing']}, 'referencesModule': {'references': [{'pmid': '25406639', 'type': 'DERIVED', 'citation': 'Beirer M, Siebenlist S, Cronlein M, Postl L, Huber-Wagner S, Biberthaler P, Kirchhoff C. Clinical and radiological outcome following treatment of displaced lateral clavicle fractures using a locking compression plate with lateral extension: a prospective study. BMC Musculoskelet Disord. 2014 Nov 19;15:380. doi: 10.1186/1471-2474-15-380.'}]}, 'descriptionModule': {'briefSummary': 'Treatment of lateral fractures of the clavicle is challenging and has been controversially discussed for a long time due to high non-union rates in non-operative treatment and high complication rates in surgical treatment. A recently developed implant was proven to ensure a biomechanically sufficient fixation of fractures leading to bony union and promising functional outcome in a small collective of patients.', 'detailedDescription': 'Treatment of lateral fractures of the clavicle is challenging and has been controversially discussed for a long time due to high non-union rates in non-operative treatment and high complication rates in surgical treatment. A recently developed implant was proven to ensure a biomechanically sufficient fixation of fractures leading to bony union and promising functional outcome in a small collective of patients.\n\nIn this prospective study patients with dislocated fractures of the lateral clavicle (Jäger\\&Breitner I-III, Neer I-III) are enrolled. All patients are surgically treated using the locking compression plate (LCP) for the superior anterior clavicle (Synthes®). Functional outcome is recorded using the Munich Shoulder Questionnaire (MSQ) allowing for qualitative self-assessment of the Shoulder Pain and Disability Index (SPADI), of the Disability of the Arm, Shoulder and Hand (DASH) score and of the Constant Score. Acromioclavicular joint stability is evaluated using the Taft-Score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from a dislocated fracture of the lateral clavicle presenting at our emergency department.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dislocated fracture of the lateral clavicle\n* Informed consent.\n\nExclusion Criteria:\n\n* Patients with a history of any other pathology such as preexisting rotator cuff tear, gleno-humeral instability, glenohumeral osteoarthritis (\\> Samilson I), Acromioclavicular joint instability, Acromioclavicular osteoarthritis, calcifying tendonitis, biceps pathology or signs of cervical root symptoms'}, 'identificationModule': {'nctId': 'NCT02256059', 'acronym': 'LatClav', 'briefTitle': 'Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension - Clinical Observational Study', 'orgStudyIdInfo': {'id': 'Beiromat_03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Plate osteosynthesis', 'description': 'Patients with fracture of the lateral clavicle and indication for surgical treatment', 'interventionNames': ['Procedure: Plate osteosynthesis']}], 'interventions': [{'name': 'Plate osteosynthesis', 'type': 'PROCEDURE', 'description': 'Plate osteosynthesis using LCP plate (Synthes)', 'armGroupLabels': ['Plate osteosynthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Chlodwig Kirchhoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dr. Chlodwig Kirchhoff', 'investigatorAffiliation': 'Technical University of Munich'}}}}