Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT05049993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-23
First Post:
2021-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pyrocarbon Clinical Follow-up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010020', 'term': 'Osteonecrosis'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'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': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-20', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-09-09', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline to last follow-up visit in ASES scores', 'timeFrame': 'Follow-up visits through 10 years Post-Op', 'description': "ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function"}], 'secondaryOutcomes': [{'measure': 'Change from Baseline to last follow-up visit in Constant Murley scores', 'timeFrame': 'Follow-up visits through 10 years Post-Op', 'description': 'Combination of physician-completed and patient-reported portions to assess functional state of shoulder including range of motion; total score reported out of 100 measuring where lower scores indicate less function of the evaluated shoulder'}, {'measure': 'Change from Baseline to last follow-up visit in SANE scores', 'timeFrame': 'Follow-up visits through 10 years Post-Op', 'description': 'SANE = Single Assessment Numeric Evaluation; 1 item assessment of shoulder rating 0% to 100%'}, {'measure': 'Change from Baseline to last follow-up visit in Subject Satisfaction scores', 'timeFrame': 'Follow-up visits through 10 years Post-Op', 'description': 'Single, subjective question measuring patient satisfaction; assessed by improved, worsened, or no change in satisfaction'}, {'measure': 'Change from Baseline to last follow-up visit in EQ-5D scores', 'timeFrame': 'Follow-up visits through 10 years Post-Op', 'description': "The EuroQol Five Dimensions Questionnaire (EQ-5D) questionnaire is a standardized instrument for use as a measure of quality of life. It is cognitively simple, takes only a few minutes to complete, and provides a simple descriptive profile as well as a single index value for quality of life that can be used in the clinical and economic evaluation of health care. The EQ-5D consists of a descriptive system which comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression), and a visual analog scale which measures the respondent's self-rated health on a 0-100 scale."}, {'measure': 'Number of device associated and procedure associated adverse events.', 'timeFrame': 'Follow-up visits through 10 years Post-Op'}, {'measure': 'Evaluation of operated shoulder range of motion', 'timeFrame': 'Follow-up visits through 10 years Post-Op'}, {'measure': 'Rates of revision surgeries.', 'timeFrame': 'Follow-up visits through 10 years Post-Op'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Shoulder', 'Avascular Necrosis', 'Traumatic Arthritis']}, 'descriptionModule': {'briefSummary': 'The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort.\n\nData collected from this study will support post-market surveillance and MDR requirements as well provide the basis for peer-reviewed publications on mid- and long-term product performance and safety (five to ten years post-op).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Long-term follow-up of Pyrocarbon IDE patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject in the Pyrocarbon IDE Study and has not had the device explanted.\n* Patient informed, willing, and able to sign an informed consent form approved by IRB or EC\n* Willing and able to comply with the requirements of the study protocol\n\nExclusion Criteria:\n\n• Subjects who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)'}, 'identificationModule': {'nctId': 'NCT05049993', 'acronym': 'PYC CFS', 'briefTitle': 'Pyrocarbon Clinical Follow-up Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Trauma and Extremities'}, 'officialTitle': 'Pyrocarbon Clinical Follow-up Study', 'orgStudyIdInfo': {'id': '20A-W-PYC-RM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aequalis Pyrocarbon Humeral Head', 'type': 'DEVICE', 'description': 'Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Western Orthopaedics', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '20602', 'city': 'Waldorf', 'state': 'Maryland', 'country': 'United States', 'facility': 'Southern Maryland Orthopedics', 'geoPoint': {'lat': 38.62456, 'lon': -76.93914}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Allina Health Orthopedics', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri Orthopaedic Institute', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Southern Oregon Orthopedics', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}], 'overallOfficials': [{'name': 'Rebecca Gibson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stryker Nordic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Trauma and Extremities', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}