Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
Study NCT ID:
NCT06754150
Status:
RECRUITING
Last Update Posted:
2025-10-28
First Post:
2024-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shoulder Innovations Clinical Data Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2039-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-24', 'studyFirstSubmitDate': '2024-12-13', 'studyFirstSubmitQcDate': '2024-12-20', 'lastUpdatePostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Durability of the device component implant', 'timeFrame': 'From the implant procedure until 10 years post-operatively', 'description': 'Assessment of the SI device component will be made at specified intervals using x-rays to check how long the device component can stay implanted with or without a revision surgery.'}], 'secondaryOutcomes': [{'measure': 'Change in range of motion (ROM) post-operatively at specified timepoints as compared to baseline', 'timeFrame': 'From baseline (pre-operatively) until 10 years post-operatively'}, {'measure': 'Change in ASES score post-operatively at specified timepoints as compared to baseline', 'timeFrame': 'From baseline (pre-operatively) until 10 years post-operatively', 'description': 'Patients will complete the ASES questionnaire (American Shoulder and Elbow Surgeons Shoulder Score) to evaluate pain and activities of daily living.'}, {'measure': 'Change in SANE score post-operatively at specified timepoints as compared to baseline', 'timeFrame': 'From baseline (pre-operatively) until 10 years post-operatively', 'description': 'Patients will complete the SANE questionnaire (Single Assessment Numeric Evaluation) to rate their affected shoulder as a percentage of normal.'}, {'measure': 'Change in PROMIS Global-10 score post-operatively at specified timepoints as compared to baseline', 'timeFrame': 'From baseline (per-operatively) until 10 years post-operatively', 'description': 'Patients will complete the PROMIS Global-10 questionnaire (Patient-Reported Outcome Measurement Information System Global-10) to evaluate pain and activities of daily living.'}, {'measure': 'Evaluation of radiographic images for radiolucent lines, implant stability and loosening', 'timeFrame': 'From baseline (pre-operatively) until 10 years post-operatively'}, {'measure': 'Rate of intra-operative and post-operative adverse device effects (ADEs)/complications', 'timeFrame': 'From the implant procedure until 10 years post-operatively'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shoulder Arthroplasty', 'Shoulder Replacement', 'Anatomic Shoulder Arthroplasty', 'Reverse Shoulder Arthroplasty'], 'conditions': ['Shoulder Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The goal of this multi-center observational study is to collect long-term clinical outcome information for anatomic and reverse total shoulder arthroplasty (shoulder replacement).', 'detailedDescription': 'The study is a non-randomized, multi-center prospective registry that will collect standard-of-care data for patients who plan to receive or have received shoulder arthroplasty (anatomic or reverse) with a Shoulder Innovations (SI) Total Shoulder System device and consent to participate in the study. The study will evaluate short and long term clinical and radiographic outcomes associated with real-world use of the arthroplasty system from the implant procedure through 10 years post-operatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (at least 18 years of age) of any gender undergoing a shoulder arthroplasty for any diagnosis/condition with at least one SI Total Shoulder System component enrolled at participating sites', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Plan to receive or has received a shoulder arthroplasty surgical procedure, with a minimum of one implanted Shoulder Innovations (SI) device component and be willing and able to complete post-operative visits as long as at least one SI device component remains implanted.\n3. Able to provide informed consent prior to enrollment in the study (unless a waiver has been obtained).\n4. Agree to and be able to consistently answer the specified Patient Reported Outcome Measures (PROM) pre-operatively and at each of the post-operative visits without the use of a translator.\n5. Willing and able to comply with the requirements of the study protocol\n\nExclusion Criteria:\n\n1. Participation in a clinical trial of an investigational drug or device that would confound the results of this trial. Participation in another observational registry is allowed provided there are no conflicting requirements to this trial.\n2. Incarceration.\n3. Any conditions, co-morbidities, restrictions, or obligations that would prohibit them from complying with the requirements of this study protocol.'}, 'identificationModule': {'nctId': 'NCT06754150', 'acronym': 'SICDR', 'briefTitle': 'Shoulder Innovations Clinical Data Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shoulder Innovations'}, 'officialTitle': 'Shoulder Innovations Clinical Data Registry', 'orgStudyIdInfo': {'id': 'SICDR 31.0.1.1.1'}}, 'contactsLocationsModule': {'locations': [{'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andie Stevenson', 'role': 'CONTACT', 'email': 'astevenson@calpacortho.com', 'phone': '415-668-8010', 'phoneExt': '2031'}, {'name': 'Mark A Schrumpf, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'California Pacific Orthopaedics', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80222', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mallory Boyd', 'role': 'CONTACT', 'email': 'Mallory.Boyd2@hcahealthone.com', 'phone': '303-253-7353'}, {'name': 'Libby Mauter', 'role': 'CONTACT', 'email': 'Libby.Mauter@hcahealthcare.com', 'phone': '303-253-7378'}, {'name': 'Benjamin W Sears, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Western Orthopaedics', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30265', 'city': 'Newnan', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hailey Abercrombie', 'role': 'CONTACT', 'email': 'hailey.abercrombie@surgerypartners.com', 'phone': '770-502-2175'}, {'name': 'Michael V Cushing, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Georgia Bone and Joint', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '02332', 'city': 'Duxbury', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'LeAnna Whittall, PA', 'role': 'CONTACT', 'email': 'lwhittall@pbortho.com', 'phone': '781-934-2400'}, {'name': 'Walter G Stanwood, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Plymouth Bay Orthopaedic Associates', 'geoPoint': {'lat': 42.04177, 'lon': -70.67226}}, {'zip': '01960', 'city': 'Peabody', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Investigator', 'role': 'CONTACT', 'email': 'rchurchill@mgb.org', 'phone': '978-531-0800'}, {'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'bthorn@mgb.org', 'phone': '978-531-0800'}, {'name': 'Ryan W Churchill, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North Shore Physicians Group', 'geoPoint': {'lat': 42.52787, 'lon': -70.92866}}], 'centralContacts': [{'name': 'Alyson Harris', 'role': 'CONTACT', 'email': 'alyson.harris@shoulderinnovations.com', 'phone': '408-667-0535'}, {'name': 'Erica Burk', 'role': 'CONTACT', 'email': 'erica.burk@shoulderinnovations.com', 'phone': '951-265-1554'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shoulder Innovations', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}