Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT04343118
Status:
COMPLETED
Last Update Posted:
2020-04-13
First Post:
2020-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Benefit of Surgical Hardware Removal Following Clavicle Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098524', 'term': 'Hardware Removal'}], 'ancestors': [{'id': 'D020878', 'term': 'Device Removal'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-08', 'studyFirstSubmitDate': '2020-04-01', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder function', 'timeFrame': '6 Week post surgery', 'description': 'Munich Shoulder Questionnaire allowing for calculation of Constant Score (0-100), Dash (0-100)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clavicle Fracture']}, 'referencesModule': {'references': [{'pmid': '33130933', 'type': 'DERIVED', 'citation': 'Wurm M, Beirer M, Zyskowski M, Volk C, Schwarz A, Biberthaler P, Kirchhoff C, Cronlein M. Does implant removal of superior clavicle plate osteosynthesis affect the functional outcome: a prospective trial. Arch Orthop Trauma Surg. 2022 Jan;142(1):139-144. doi: 10.1007/s00402-020-03669-z. Epub 2020 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'Little is known about the beneficial aspects of elective implant removal following plate osteosynthesis of displaced clavicle fractures.', 'detailedDescription': "Elective implant removal accounts for up to 30% of all orthopaedic surgeries. While there is general acceptance about the need of implant removal for obvious reasons, such as infections or implant failure, little is known about the beneficial aspects in cases of minor reasons. Therefore, we initiated this study to define patients' benefit of elective implant removal following plate osteosynthesis of displaced clavicle fractures.\n\nPatients and Methods Prospective evaluation of patients was conducted before implant removal and 6 weeks postoperative. Subjective and objective criteria included patients' satisfaction, pain rating on a visual analog scale (VAS) and active range of motion (ROM) pre- and 6 weeks postoperative. Functional scoring included the SPADI, DASH score, the Constant Score and the Munich Shoulder Questionnaire (MSQ)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requesting implant removal', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years\n* Radiologically consolidated clavicle fracture\n* following ORIF using a superior anatomically preformed locking plate\n* asking for elective implant removal\n* written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy\n* Under-aged\n* Delinquent patients.'}, 'identificationModule': {'nctId': 'NCT04343118', 'briefTitle': 'Benefit of Surgical Hardware Removal Following Clavicle Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Do Patients Benefit From Elective Implant Removal Following Plate Osteosynthesis of Clavicle Fractures - a Prospective Trial', 'orgStudyIdInfo': {'id': '089_2019ME'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group Removal', 'description': 'All patient receiving surgical removal of plate osteosynthesis', 'interventionNames': ['Procedure: Hardware Removal']}], 'interventions': [{'name': 'Hardware Removal', 'type': 'PROCEDURE', 'description': 'elective removal of plate osteosynthesis at the clavicle', 'armGroupLabels': ['Group Removal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Chlodwig Kirchhoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum rechts der Isar, TU München'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Dr. Chlodwig Kirchhoff', 'investigatorAffiliation': 'Technical University of Munich'}}}}