Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-10 @ 3:30 PM
Study NCT ID:
NCT04041258
Status:
TERMINATED
Last Update Posted:
2022-04-15
First Post:
2019-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562548', 'term': 'Clavicle, Pseudarthrosis Of, Congenital'}, {'id': 'D011542', 'term': 'Pseudarthrosis'}], 'ancestors': [{'id': 'D005599', 'term': 'Fractures, Ununited'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'interventional study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'the number of patients was not sufficient to support continuation of the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-08', 'studyFirstSubmitDate': '2019-07-30', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'range of motion ROM', 'timeFrame': 'at least 1 year of follow up', 'description': 'improvement of range of motion measure (in grade)'}, {'measure': 'presence of dyskinesias', 'timeFrame': 'at least 1 year of follow up', 'description': 'objective clinical evaluation (elevation, external rotation, abduction) with constant scale (0-25 points)'}, {'measure': 'alteration of the clavicle length', 'timeFrame': 'at least 1 year of follow up', 'description': 'measure (mm) obtained from radiographic evaluation'}], 'secondaryOutcomes': [{'measure': 'evaluate shoulder function', 'timeFrame': 'at least 1 year of follow up', 'description': 'improvement in Assessment Shoulder and Elbow Scale (ASES) (0-100 points)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pseudoarthrosis', 'clavicle'], 'conditions': ['Pseudoarthrosis of the Clavicle']}, 'descriptionModule': {'briefSummary': 'This is an interventional study for clinical and radiographic evaluation of patients operated for pseudoarthrosis of the clavicle', 'detailedDescription': 'The aim of our study is to collect clinical and radiographic data from patients operated for pseudoarthrosis of the clavicle from 2007 to 2017 at the Rizzoli Orthopedic Institute, in order to evaluate the clinical and radiographic results of the treatment. This is an interventional study and patients will be contacted by telephone to verify their willingness to perform a visit (including a bilateral radiographic) at the Rizzoli Orthopedic Institute'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-65 years of pseudarthrosis intervention\n2. Males and Females\n3. Patients treated for pseudoarthrosis of the clavicle between 2007 and 2017 at the Rizzoli Orthopedic Institute\n\nExclusion Criteria:\n\n1. Floating shoulder\n2. subjects who present contraindications to radiographic examination at the time of telephone contact'}, 'identificationModule': {'nctId': 'NCT04041258', 'acronym': 'CLAPS', 'briefTitle': '"Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws"', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': '"Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws"', 'orgStudyIdInfo': {'id': 'CLAPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'evaluation of clinical and radiographic findings after surgical treatment', 'description': 'Evaluation of clinical and radiographic findings at least 1 year after surgical treatment for pseudoarthrosis of clavicle', 'interventionNames': ['Procedure: pseudoarthrosis of clavicle']}], 'interventions': [{'name': 'pseudoarthrosis of clavicle', 'type': 'PROCEDURE', 'description': 'Pseudoarthrosis represents a complication following a fracture, resulting in persistent symptoms and functional limitation, which prolongs the recovery time for the patient and necessitates new surgery. The purpose of surgery for pseudoarthrosis is to re-establish the length and alignment of the clavicle in an environment favorable to the union of bone fragments.', 'armGroupLabels': ['evaluation of clinical and radiographic findings after surgical treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Rizzoli Orthopaedic Institute', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}