Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-03-10 @ 11:45 PM
Study NCT ID:
NCT03247335
Status:
COMPLETED
Last Update Posted:
2021-03-08
First Post:
2017-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up of Arthrosurface HemiCAP Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2017-08-09', 'studyFirstSubmitQcDate': '2017-08-09', 'lastUpdatePostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arthrosurface', 'timeFrame': '2 year', 'description': 'survival curve for the implant'}], 'secondaryOutcomes': [{'measure': 'Rate of revision surgeries', 'timeFrame': '2 year', 'description': 'rate of revision surgeries'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthopedic Disorder']}, 'descriptionModule': {'briefSummary': 'Follow-up of Arthrosurface HemiCAP shoulder implants.', 'detailedDescription': 'In summary, the investigators would like to contact all patients who have had HemiCAP implants done at CCF with at least 2 years of follow-up after their procedure. The investigators will use electronic or written means to alert the patients that they will be contacted by our team to discuss their surgery and any related issues. Once the appropriate consent is obtained, the investigators will use a brief telephone interview to ask the patients several questions regarding any re-operations or complications the patients have had since the index procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had Arthrosurface (Franlin, MA) HemiCAP implants placed into their shoulders at the Cleveland Clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients who had Arthrosurface (Franlin, MA) HemiCAP implants placed into their shoulders at the Cleveland Clinic\n\nExclusion Criteria:\n\n* Anyone who has not had ARthrosurface (Franlin, MA) HeiCAP implants placed into their shoulders at the Cleveland Clinic'}, 'identificationModule': {'nctId': 'NCT03247335', 'briefTitle': 'Follow-up of Arthrosurface HemiCAP Implants', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Follow-up of Arthrosurface HemiCAP Implants', 'orgStudyIdInfo': {'id': '17-341'}}, 'contactsLocationsModule': {'locations': [{'zip': '44125', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Kurt Spindler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Arthrosurface, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}