Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-31 @ 6:08 AM
Study NCT ID:
NCT01410032
Status:
COMPLETED
Last Update Posted:
2014-04-28
First Post:
2011-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-25', 'studyFirstSubmitDate': '2011-05-23', 'studyFirstSubmitQcDate': '2011-08-03', 'lastUpdatePostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DASH score', 'timeFrame': '6 months', 'description': 'Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)'}], 'secondaryOutcomes': [{'measure': 'DASH score', 'timeFrame': '12 months', 'description': 'Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)'}, {'measure': 'Constant-Murley Score', 'timeFrame': '6 and 12 months PO', 'description': 'Shoulder functional score (0: worst function; 100: best function)'}, {'measure': 'Time to Union', 'timeFrame': 'Monthly', 'description': 'Time necessary to reach complete union measured in weeks'}, {'measure': 'Radiographic residual shortening', 'timeFrame': '6 months', 'description': 'Clavicles shortening compared to the contralateral side'}, {'measure': 'Patient satisfaction with the treatment', 'timeFrame': '6 and 12 months', 'description': 'Subjective measurement. Patients are questioned about their satisfaction with the treatment instituted. Binary outcome.'}, {'measure': 'Complication rate', 'timeFrame': 'Monthly', 'description': 'Complications were divided in Minor and Major, as follows:\n\nMinor: paresthesia, transient neurologic deficit, implant deformation, partial implant migration, acromioclavicular or sternoclavicular pain, hardware related pain\n\nMajor: permanent neurologic deficit, total implant failure, total implant migration, refracture, reoperation, nonunion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['clavicle', 'clavicular', 'fracture', 'midshaft', 'plate', 'ESIN', 'intramedullary', 'flexible', 'nailing'], 'conditions': ['Clavicle Fracture']}, 'referencesModule': {'references': [{'pmid': '25878305', 'type': 'DERIVED', 'citation': 'Andrade-Silva FB, Kojima KE, Joeris A, Santos Silva J, Mattar R Jr. Single, superiorly placed reconstruction plate compared with flexible intramedullary nailing for midshaft clavicular fractures: a prospective, randomized controlled trial. J Bone Joint Surg Am. 2015 Apr 15;97(8):620-6. doi: 10.2106/JBJS.N.00497.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with plates or intramedullary flexible nails fixation.', 'detailedDescription': 'Midshaft clavicular fractures are classically treated with non-surgical methods, supported by many authors as an effective treatment. However, different researches have shown high rates of nonunion and clavicle malunion related to the nonoperative treatment. Currently, indications for surgical treatment are wider and include mainly the following: shortening greater than or equal to 2.0 cm, multiple trauma, open fractures or with imminent exposure and associated neurovascular injury.\n\nPlate fixation of midshaft clavicular fractures is widely described in the literature, and is considered the gold standard by different authors, associated with a high union rate and a low complication rate. Different types of plates have been used, including reconstruction plates, dynamic compression plates (DCP), low-contact dynamic compression plates (LC-DCP), semi-tubular plates, and pre-molded locking plates. Possible complications are postoperative infection, hardware loosening or failure, peri-incision paresthesia, neurovascular iatrogenic lesions, nonunion, and hardware related symptoms.\n\nElastic stable intramedullary nailing (ESIN) technique has been used in recent years in the treatment of midshaft clavicular fractures. Different studies report excellent functional results and low complication rates. Some theoretical advantages in relation to plates are the 3-point flexible nail support, which provides superior biomechanics resistance and uses the relative stability principle, favoring callus formation. When compared to plain steel wires, titanium nails have lower migration risk, due to its greater flexibility and better bone fixation.\n\nThe purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with reconstruction plates or ESIN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Displaced Fractures of the middle third of the clavicle (no contact between the main fragments)\n2. Age between 16 and 65 year old;\n3. Terms of consent signed by the patient or guardian.\n\nExclusion Criteria:\n\n1. Fracture of medial or lateral third of the clavicle;\n2. Cortical contact between the main fracture fragments;\n3. Age below 16 years old or more than 65 years old;\n4. Pathological fracture;\n5. Ipsilateral previous injuries of the shoulder or upper limb;\n6. Ipsilateral associated fractures of the shoulder or upper limb;\n7. Neuro-vascular injury associated;\n8. Open fracture not eligible for primary internal fixation;\n9. Clinical contraindication for surgery;\n10. Fracture older than 30 days;\n11. Patient not cooperative or ineligible for the follow-up;\n12. Lack of consent to participate.'}, 'identificationModule': {'nctId': 'NCT01410032', 'briefTitle': 'Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures: a Prospective, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'IOT-HCFMUSP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plate fixation', 'description': 'Reconstruction plate', 'interventionNames': ['Procedure: Plate fixation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ESIN', 'description': 'ESIN (Elastic Stable Intramedullary Nailing)', 'interventionNames': ['Procedure: ESIN']}], 'interventions': [{'name': 'Plate fixation', 'type': 'PROCEDURE', 'description': 'Reconstruction plate', 'armGroupLabels': ['Plate fixation']}, {'name': 'ESIN', 'type': 'PROCEDURE', 'description': 'ESIN (Elastic Stable Intramedullary Nailing)', 'armGroupLabels': ['ESIN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of Sao Paulo - Department of Orthopedics and Traumatology', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Fernando B Andrade-Silva, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo - Department of Orthopedics and Traumatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Fernando B Andrade-Silva, MD', 'investigatorAffiliation': 'University of Sao Paulo'}}}}