Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-29 @ 2:53 AM
Study NCT ID:
NCT00590850
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2007-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001860', 'term': 'Bone Plates'}], 'ancestors': [{'id': 'D016268', 'term': 'Internal Fixators'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 412}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2007-12-28', 'studyFirstSubmitQcDate': '2007-12-28', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability of Arm, Shoulder and Hand (DASH) scores', 'timeFrame': '1 year', 'description': 'Disability of Arm, Shoulder and Hand (DASH) scores'}], 'secondaryOutcomes': [{'measure': 'Reoperation rate', 'timeFrame': '1 year', 'description': 'rate of reoperations between groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Energy Midshaft Clavicle Fractures']}, 'referencesModule': {'references': [{'pmid': '38837208', 'type': 'DERIVED', 'citation': 'Jeray KJ, Broderick JS, Mullis BH, Everhart J, Tanner SL, Snider BG; Southeastern Fracture Consortium. Multicenter, Prospective, Observational Study of Nonoperative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures. J Orthop Trauma. 2024 Jul 1;38(7):345-350. doi: 10.1097/BOT.0000000000002817.'}]}, 'descriptionModule': {'briefSummary': 'Clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder. Some surgeons suggest that surgical treatment is the best option, while others suggest that nonoperative care is the best treatment. There is no evidence to date that either option in superior. For this reason, we propose to conduct a prospective, randomized clinical trial of surgical versus non-surgical treatment of displaced high-energy clavicle fractures. This study will use both objective clinical and patient-based outcome measures. The purpose of this study is to see if there is a difference between clinical outcomes (healing rate, time to healing, time to return to work, Constant Score, complications), functional outcomes (DASH Score), and health related quality of life (SF-36) in nonoperative care and two types of surgical care for displaced fractures of the clavicular shaft in adults.\n\nIncluded patients will be randomized into one of three groups: nonoperative care (Group N); surgical care using plates and screws (Group P); and surgical care using intramedullary pin put inside of the clavicle to stabilize it (Group I).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages of 18 and 85\n* a midshaft clavicle fracture\n* fracture displaced the width of the clavicle or shortened at least 1.5 cm\n* less than 21 days since the injury\n\nExclusion Criteria:\n\n* injury involving the lateral ligaments\n* fracture involve the sternoclavicular joint\n* Pathologic Fracture\n* Open Fracture\n* Fracture with neurovascular compromise\n* Displaced fracture with impending skin compromise\n* Medical comorbidities that preclude surgery\n* Associated injuries to ipsilateral shoulder girdle\n* severe cognitive disability or injury that may inhibit study form completion'}, 'identificationModule': {'nctId': 'NCT00590850', 'briefTitle': 'Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Prisma Health-Upstate'}, 'officialTitle': 'A Multicenter, Prospective, Randomized Trial of Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures', 'orgStudyIdInfo': {'id': 'GHS-07-03-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Closed', 'description': 'Closed Treatment'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ORIF', 'description': 'Open Reduction and Internal Fixation (ORIF) with Plate and Screws', 'interventionNames': ['Procedure: ORIF with Plate and Screws']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pin', 'description': 'Pin Fixation', 'interventionNames': ['Procedure: Pin Fixation']}], 'interventions': [{'name': 'ORIF with Plate and Screws', 'type': 'PROCEDURE', 'description': 'ORIF with plate and screws', 'armGroupLabels': ['ORIF']}, {'name': 'Pin Fixation', 'type': 'PROCEDURE', 'description': 'Clavicle fixation with clavicle pin', 'armGroupLabels': ['Pin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}], 'overallOfficials': [{'name': 'Kyle J Jeray, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Greenville Hospital System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prisma Health-Upstate', 'class': 'OTHER'}, 'collaborators': [{'name': 'Orthopaedic Trauma Association', 'class': 'OTHER'}, {'name': 'Indiana University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}