Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-25 @ 2:42 PM
Study NCT ID:
NCT06555250
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2022-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interest of Bone Scintigraphy in the Search for Scaphotrapezoidal Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2022-07-04', 'studyFirstSubmitQcDate': '2024-08-12', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Search for a statistically significant association between scintigraphic STT hyperfixation and residual pain after TM prosthesis for patients with no radiographically obvious STT involvement.', 'timeFrame': 'before surgery and 4 month after surgery', 'description': 'STT scintigraphic hyperfixation and pain before surgery and 4 months after TM arthroplasty'}], 'secondaryOutcomes': [{'measure': 'Search for an association between scintigraphic STT hyperfixation in quantitative analysis and residual pain after TM prosthesis for patients without advanced STT involvement on radiography.', 'timeFrame': 'before surgery', 'description': 'SUVmax STT and pain before surgery and 4 months after TM arthroplasty'}, {'measure': 'Assessing the involvement of other carpal joint compartments', 'timeFrame': 'before surgery', 'description': 'Scintigraphic hyperfixation of other carpal joint compartments and pain before surgery and 4 months after TM arthroplasty'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rhizarthrosis', 'bone scintigraphy'], 'conditions': ['Rhizarthrosis', 'Prosthesis Failure']}, 'descriptionModule': {'briefSummary': 'Rhizarthosis can be treated by prothesis of the carpo-metacarpal (CM) joint of the thumb. But, if the scaphotrapeziotrapezoid (STT) joint is also affected by arthrosis, treating the CM joint exclusively may result in partial pain relief. Thus, bone scintigraphy could identify early arthrosis of the STT joint when its appearance seems to be normal on planar radiography, suggesting another surgical procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient who beneficiate of a bone scintigraphy before arthroplasty for rhizarthrosis with failure medical treatment, without osteoarthritis of the STT joint on planar radiography', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* failure of medical treatment of rhizarthrosis\n* eligibility for prothesis\n* no osteoarthritis of the STT joint on planar radiography\n* no opposition from the patient\n\nExclusion Criteria:\n\n* Refusal by a patient'}, 'identificationModule': {'nctId': 'NCT06555250', 'acronym': 'PSR', 'briefTitle': 'Interest of Bone Scintigraphy in the Search for Scaphotrapezoidal Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Interest of Bone Scintigraphy in the Search for Scaphotrapezoidal Osteoarthritis in the Context of Preoperative Assessment of Rhizarthrosi', 'orgStudyIdInfo': {'id': '29BRC21.0207 - PSR'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available after the publication of result and ending five years maximum following the last visit of the last patient', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}