Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
Study NCT ID:
NCT03891966
Status:
COMPLETED
Last Update Posted:
2023-10-27
First Post:
2019-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-26', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-03-26', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in Visual Analog Scale (VAS)', 'timeFrame': '14 Days', 'description': 'Best state you can imagine is marked 100and the worst state you can imagine is marked 0 on a line'}, {'measure': 'Percent Change in Euro Quality of Life (EQ-5D)', 'timeFrame': '14 Days', 'description': "The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Upper Extremity Fracture'], 'conditions': ['Extremity Injury']}, 'referencesModule': {'references': [{'pmid': '38117579', 'type': 'DERIVED', 'citation': 'Sgaglione MW, Solasz SJ, Leucht P, Egol KA. Is Postoperative Splinting Advantageous After Upper Extremity Fracture Surgery? Results From the Arm Splint Pain Improvement Research Experiment. J Orthop Trauma. 2024 Mar 1;38(3):e92-e97. doi: 10.1097/BOT.0000000000002742.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine if applying a rigid splint helps to reduce pain following operative fixation of upper extremity fractures. Orthopedic trauma surgeons currently vary in their application of rigid post-operative splints versus soft dressings after certain surgical procedures based on personal preference. In this study, 100 patients undergoing operative fixation of isolated both bone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a splint or soft dressing post-operatively. Their pain, medication usage and function will be tracked over the 2- week postoperative period to see if splinting has any impact on outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to participate in study and complete consent\n* Will undergo operative fixation of an isolated both bone forearm, radial head, olecranon, distal humerus fracture, or humeral shaft fracture.\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients with concomitant TBI or MR\n* Polytrauma patients\n* Pathologic Fractures\n* Patients undergoing treatment for malignancy\n* NYU SoM Students, Residents, Faculty\n* Prisoners\n* IV drug users or patients on chronic narcotics\n* Gun shot wound victims'}, 'identificationModule': {'nctId': 'NCT03891966', 'briefTitle': 'Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?', 'orgStudyIdInfo': {'id': '18-01505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Splint', 'interventionNames': ['Procedure: Rigid Splint']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Soft Dressing', 'interventionNames': ['Procedure: Soft Dressing']}], 'interventions': [{'name': 'Rigid Splint', 'type': 'PROCEDURE', 'description': '50 patients undergoing operative fixation of isolated bothbone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a splint.', 'armGroupLabels': ['Splint']}, {'name': 'Soft Dressing', 'type': 'PROCEDURE', 'description': '50 patients undergoing operative fixation of isolated both bone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a soft dressing post-operatively.', 'armGroupLabels': ['Soft Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Philipp Leucht, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Langone Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'Requests should be directed to Philipp.Leucht@nyulangone.org To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}