Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-02-18 @ 1:19 AM
Study NCT ID:
NCT06172569
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study
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': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2023-12-07', 'studyFirstSubmitQcDate': '2023-12-07', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Radiographic Analysis', 'timeFrame': 'up to 2 years.', 'description': 'Post-operative radiographs of the implant are analysed to identify locations and sizes of radiolucency, indicative of poor fixation. The size, location and progression of radiolucency is monitored. Smaller, non-progressive radiolucencies are preferred.'}], 'primaryOutcomes': [{'measure': 'Spartan Stem, World Acetabular Cup and World Liner Survival Rate', 'timeFrame': 'up to 2 years', 'description': 'The implant survival rate is based on removal of the device for any reason as determined following the Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Oxford Hip Score (OHS)', 'timeFrame': 'up to 2 years', 'description': 'The OHS is a patient reported outcome measure (PROM) used to quantify patient satisfaction with the treatment. It consists of 12 questions scored 1 to 5 by the patient.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hip Replacement']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to monitor the performance of the Signature Orthopaedics Spartan Stem, World Acetabular Cup and World Liner as a post-market vigilance and continuous improvement efforts.', 'detailedDescription': 'The objective of this PMCF Study is to collect data confirming safety, performance and clinical benefits of the Spartan Stem, World Acetabular Cup and the World Liner when used for primary total hip arthroplasty at 2-years follow-up.\n\nThe study includes pre-operative, operative, discharge, 1 year post-operative evaluations, where data concerning the performance and safety of the device are gathered.\n\nThe revision rate of the components will be monitored as the primary objective, along with pre and post operative measurement of the Oxford Hip Score (OHS), patient-reported outcome measure (PROM) to quantify patient satisfaction.\n\nRadiography analysis will be done to monitor bony response to the implant and qualify the effectiveness of the cementless fixation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of the Cleveland Clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g., osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/DDH)\n* patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient.\n* male and non-pregnant female patients aged 18-75\n* patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up.\n\nExclusion Criteria:\n\n* patient has active infection or sepsis(treated or untreated) enough to compromise implant stability or postoperative recovery\n* patient is a female of child-bearing age and not taking and not taking contraceptive pills\n* patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)\n* patient has a known or suspected metal sensitivity\n* patient is immuno-suppressed with disease such as AIDS or is receiving high dose of cortico-steroids.\n* patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the clinical evaluation including mental illness, mental retardation or drug abuse\n* patient is severely overweight with a BMI\\>40.'}, 'identificationModule': {'nctId': 'NCT06172569', 'briefTitle': 'Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Signature Orthopaedics'}, 'officialTitle': 'Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study', 'orgStudyIdInfo': {'id': '111-440-100'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Spartan Stem, World Acetabular Cup and World Liner', 'type': 'DEVICE', 'description': 'The Spartan Stem is a wedge-shaped fit and fill design stem with Titanium Plasma Spray(TPS) and Hydroxyapatite (HA) coating.\n\nThe World Acetabular cup is Porous coated and mated with cross-linked polyethylene World Liner'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura Stiegel', 'role': 'CONTACT', 'email': 'STIEGEL@ccf.org'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Satish Shejale, MS Ortho', 'role': 'CONTACT', 'email': 'satish.shejale@signatureortho.com.au', 'phone': '+61 02 9428 5181'}, {'name': 'Declan Brazil, PhD', 'role': 'CONTACT', 'email': 'declan@signatureortho.com.au', 'phone': '+61 02 9428 5181'}], 'overallOfficials': [{'name': 'Nicolas Piuzzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Signature Orthopaedics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Cleveland Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}