Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-03-11 @ 11:34 PM
Study NCT ID:
NCT05591859
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2022-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Restoration Anatomic Acetabular Shell Revision Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2036-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2022-10-19', 'studyFirstSubmitQcDate': '2022-10-19', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2036-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate', 'timeFrame': '10 years', 'description': 'Success rate is defined as no incidence of revision for aseptic loosening'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '10 years', 'description': 'All protocol defined adverse events as well as all-cause revision and/or removal of RAS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Arthropathy', 'Hip Arthropathy', 'Hip Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study will be a non-randomized, ambidirectional (retrospective and prospective) study where all subjects will be followed prospectively. The study will evaluate the survivorship of the RAS acetabular component in a previously failed total hip arthroplasty (THA) in a consecutive series of subjects who meet the eligibility criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is a candidate for a revision of a failed acetabular component with the Restoration Anatomic Acetabular Shell.\n* Subject has signed an IRB-approved, study specific Informed Consent Form (ICF).\n* Subject is skeletally mature.\n* Subject is a male or non-pregnant female.\n* Subject is willing and able to comply with postoperative scheduled clinical evaluations.\n\nExclusion Criteria:\n\n* Subject has a non-Stryker retained stem at the time of study device implantation.\n* Subject has a Body Mass Index (BMI) \\> 45.\n* Subject has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.\n* Subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.\n* Subject has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.\n* Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.\n* Subject is immunologically suppressed or receiving steroids in an excess of normal physiological requirements (e.g. \\> 30 days).\n* Subject has a known sensitivity to device materials.\n* Subject is a prisoner."}, 'identificationModule': {'nctId': 'NCT05591859', 'acronym': 'RAS', 'briefTitle': 'Restoration Anatomic Acetabular Shell Revision Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Orthopaedics'}, 'officialTitle': 'Restoration Anatomic Acetabular Shell Revision Study - A Post-market, Multi-center Evaluation of the Clinical Outcomes of the Restoration Anatomic Acetabular Shell in a Revision Indication', 'orgStudyIdInfo': {'id': '105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Restoration Anatomic Acetabular Shell', 'interventionNames': ['Device: Restoration Anatomic Acetabular Shell']}], 'interventions': [{'name': 'Restoration Anatomic Acetabular Shell', 'type': 'DEVICE', 'description': 'Multi-hole acetabular shell intended for cementless fixation into a prepared acetabulum and is a modular component design that is assembled intra-operatively.', 'armGroupLabels': ['Restoration Anatomic Acetabular Shell']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Frank Somoza', 'role': 'CONTACT', 'email': 'frank.somoza@cuanschutz.edu'}, {'name': 'Craig Hogan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Regents of the University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'centralContacts': [{'name': 'Sabrina Cristofaro', 'role': 'CONTACT', 'email': 'sabrina.cristofaro@stryker.com', 'phone': '5513298665'}, {'name': 'Marissa Puccio', 'role': 'CONTACT', 'email': 'marissa.puccio@stryker.com', 'phone': '2016751416'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}