Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-24 @ 3:15 AM
Study NCT ID:
NCT03805204
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2018-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascularity of the Ulna and Its Association With Forearm Nonunion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070799', 'term': 'Open Fracture Reduction'}, {'id': 'D005593', 'term': 'Fracture Fixation, Internal'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2018-12-21', 'studyFirstSubmitQcDate': '2019-01-14', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Avascular areas in anatomical study', 'timeFrame': '8 months', 'description': 'The extraossea and intraossea vascularity of the forearms with Spalteholz dissection technique and Tompsett dissection technique will be described. The location, distribution and dimensions of the vessels and the areas without vascularity will be measured with a digital caliper (mm).'}, {'measure': 'Epidemiological risk factors for ulnar nonunion', 'timeFrame': '8 months', 'description': 'Epidemiological risks factor such as: smoke, heart problems, rheumatic disorders will be registered.'}, {'measure': 'Biomechanical risk factors for ulnar nonunion', 'timeFrame': '8 months', 'description': 'Biomechanical risk factors will be evaluated using the OTA/AO classification.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Forearm Fracture']}, 'referencesModule': {'references': [{'pmid': '20217106', 'type': 'BACKGROUND', 'citation': 'Kloen P, Wiggers JK, Buijze GA. Treatment of diaphyseal non-unions of the ulna and radius. Arch Orthop Trauma Surg. 2010 Dec;130(12):1439-45. doi: 10.1007/s00402-010-1071-x. Epub 2010 Mar 9.'}, {'pmid': '22113538', 'type': 'BACKGROUND', 'citation': 'Kloen P, Buijze GA, Ring D. Management of forearm nonunions: current concepts. Strategies Trauma Limb Reconstr. 2012 Apr;7(1):1-11. doi: 10.1007/s11751-011-0125-0. Epub 2011 Nov 24.'}, {'pmid': '24332651', 'type': 'BACKGROUND', 'citation': 'Bartonicek J, Kozanek M, Jupiter JB. History of operative treatment of forearm diaphyseal fractures. J Hand Surg Am. 2014 Feb;39(2):335-42. doi: 10.1016/j.jhsa.2013.06.020. Epub 2013 Dec 11.'}, {'pmid': '21489724', 'type': 'BACKGROUND', 'citation': 'Hardy BT, Glowczewskie F Jr, Wright TW. Vascular anatomy of the proximal ulna. J Hand Surg Am. 2011 May;36(5):808-10. doi: 10.1016/j.jhsa.2011.02.011. Epub 2011 Apr 12.'}, {'pmid': '8583061', 'type': 'BACKGROUND', 'citation': 'Sheetz KK, Bishop AT, Berger RA. The arterial blood supply of the distal radius and ulna and its potential use in vascularized pedicled bone grafts. J Hand Surg Am. 1995 Nov;20(6):902-14. doi: 10.1016/S0363-5023(05)80136-4.'}]}, 'descriptionModule': {'briefSummary': 'Non-union after operative treatment of an ulnar fracture is very uncommon. There are severely disabling and challenging to treat. Multiple factors have been associated with the establishment of this non-union. Many non-unions are associated with soft tissue damage, fracture site vascularity, persistent instability, infection, and the surgical treatment technique. This study analysed the systemic conditions and local factors associated with the failure of bone fracture healing The aim of our study was to identify the risk factors for ulnar nonunion', 'detailedDescription': "In the anatomical study we investigated the extraosseous and intraosseous blood supply in fourteen specimens from the Department of Human Anatomy. We correlated the areas with a low vascularity with the usual areas that patients have ulnar nonunion.\n\nIn the clinical study we retrospectively reviewed a cohort of ulnar fractures treated surgically with open reduction and internal fixation (ORIF), during a period of 10 years (2007-2016). We identified 211 ulnar fractures. All patients had a minimum follow-up of 1 year. We defined non-union if there was no radiological consolidation of the fracture after this period, and we classified them according to Weber classification. We assessed risk factors like: fracture site vascularity, surgical treatment technique, biological factors of the patient, and the fracture's mechanism. We correlated data and associated risk factors from the anatomical and the clinical studies.\n\nData were analysed using SPSS software system version 21. Multivariate regression analysis was performed to assess independent risk factors of ulnar non-union. Chi square test or Fisher exact test was used to compare categorical measurements. Statistical significance was considered as p less than 0.05."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Anatomical study: 14 upper extremities from the Department of Human Anatomy. Clinical study. Records about 211 ulnar fractures. We included only the fractures with the complication of ulnar nonunion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults from 18 to 90 years old\n* Forearm ulnar nonunion\n\nExclusion Criteria:\n\n* Children\n* Other types of forearm fractures'}, 'identificationModule': {'nctId': 'NCT03805204', 'acronym': 'Nonunion', 'briefTitle': 'Vascularity of the Ulna and Its Association With Forearm Nonunion', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Anatomical Study About the Vascularization of the Ulna: Vascular and Mechanical Risk Factors Associated With Forearm Nonunion', 'orgStudyIdInfo': {'id': 'IIBSP-CUB-2018-61'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Open reduction and internal fixation (ORIF)', 'type': 'PROCEDURE', 'description': 'ORIF with a forearm plate'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Claudia Lamas, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'When we have the results we analyse the anatomical and clinical data and association with the differents risks factors in the Department of Statistics.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}