Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT05325268
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2022-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monteggia Fractures: Analysis of Patient Reported Outcome Measurements in Correlation to Ulnar Fracture Localization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009011', 'term': "Monteggia's Fracture"}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D000072039', 'term': 'Fracture Dislocation'}, {'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014458', 'term': 'Ulna Fractures'}]}, 'interventionBrowseModule': {'meshes': [{'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2022-03-28', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disabilities of Arm, Shoulder and Hand Score (DASH)', 'timeFrame': 'Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months', 'description': 'Evaluation of the subjective function (patient reported outcome) using the DASH-Score, 0-100, best: 0, worst: 100'}, {'measure': 'Oxford Elbow Score (OES)', 'timeFrame': 'Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months', 'description': 'Evaluation of the subjective function (patient reported outcome) using the OES-Score, 0 - 48, best: 48, worst: 0'}, {'measure': 'Mayo Elbow Performance Score (MEPS)', 'timeFrame': 'Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months', 'description': 'Evaluation of the subjective function (patient reported outcome) using the MEPS-Score, 0-100, best: 100, worst: 0'}, {'measure': 'Range of Motion (ROM)', 'timeFrame': 'Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months', 'description': 'Objective functional clinical result. Evaluation of Motion of the Elbow in ° measured via goniometer. Physiological: Flexion/Extension 140/0/0°.'}], 'secondaryOutcomes': [{'measure': 'Ulnar fracture localization (Radiologically)', 'timeFrame': 'baseline (timepoint of injury)', 'description': 'Localization of ulnar fracture was measured from the proximal tip of the Olecranon to the fracture line on conventional X-ray in order to assess whether further distal fractures have a worse outcome compared to fractures with a close relation to or affecting the elbow joint \\[cm\\]'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['elbow', 'fracture', 'patient reported outcome'], 'conditions': ["Monteggia's Fracture"]}, 'referencesModule': {'references': [{'pmid': '35672754', 'type': 'DERIVED', 'citation': 'Tille E, Seidel L, Schlussler A, Beyer F, Kasten P, Bota O, Biewener A, Nowotny J. Monteggia fractures: analysis of patient-reported outcome measurements in correlation with ulnar fracture localization. J Orthop Surg Res. 2022 Jun 7;17(1):303. doi: 10.1186/s13018-022-03195-1.'}]}, 'descriptionModule': {'briefSummary': 'Patients who had suffered a Monteggia fracture (lesion of the elbow) will be assessed regarding clinical and functional outcome (PROM) after treatment with osteosynthesis.', 'detailedDescription': 'A retrospective, monocentric study will be performed. Patients who underwent surgical treatment after suffering a Monteggia injury or a Monteggia like lesion between 2012 and 2018 will be included. Fractures will classified after Bado and Jupiter, according to the fracture location of the proximal ulna, as well as regarding the potential accompanying ligamentary injury.\n\nIn a follow-up examination validated patient-reported outcome measures (Disabilities of Arm, Shoulder and Hand Score \\[DASH\\], MEPS \\[Mayo Elbow Performance Score\\], Oxford Elbow Score \\[OES\\], Pain, Subjective Elbow Score) and functionality (range of motion \\[ROM\\], posterolateral instability, strength, valgus-/varus-stress) will be evaluated. In addition, treatment strategy and complications will be analysed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated at the University Hospital Dresden.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Monteggia fractures treated with osteosynthesis between 2012 and 2018\n* understanding of German language (written and oral)\n* informed consent\n\nExclusion Criteria:\n\n* Patients not meeting the above criteria'}, 'identificationModule': {'nctId': 'NCT05325268', 'briefTitle': 'Monteggia Fractures: Analysis of Patient Reported Outcome Measurements in Correlation to Ulnar Fracture Localization', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Monteggia Fractures: Analysis of Patient Reported Outcome Measurements in Correlation to Ulnar Fracture Localization', 'orgStudyIdInfo': {'id': 'Monteggia PROM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Monteggia Cohort', 'description': 'Including all Patients. Patients who had suffered a Monteggia fracture and were treated with osteosynthesis', 'interventionNames': ['Procedure: Osteosynthesis']}], 'interventions': [{'name': 'Osteosynthesis', 'type': 'PROCEDURE', 'description': 'Treatment of fracture with open reduction and osteosynthesis', 'armGroupLabels': ['Monteggia Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No. Data may be shared upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}