Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT05734651
Status:
RECRUITING
Last Update Posted:
2023-02-21
First Post:
2023-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PROMIS Evaluation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D007873', 'term': 'Legg-Calve-Perthes Disease'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D005265', 'term': 'Femoral Neck Fractures'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D005271', 'term': 'Femur Head Necrosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2042-02-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2023-02-09', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stem Migration', 'timeFrame': '20 years', 'description': 'Stem Migration measured with the validated EBRA method. The stem migration is assessed in millimeters. The radiograph before surgery and sequential radiographs after surgery are assessed.'}], 'secondaryOutcomes': [{'measure': 'WOMAC Score', 'timeFrame': '20 years', 'description': 'Patient reported outcome score that is assessed before the surgery and one year after the surgery, 5 years after the surgery, 10 years and 20 years after the surgey.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hip Arthropathy', 'Osteoarthritis, Hip', 'Perthes Disease', 'Osteonecrosis', 'Femoral Neck Fractures']}, 'referencesModule': {'references': [{'pmid': '36042064', 'type': 'RESULT', 'citation': 'Wagner M, Neururer S, Dammerer D, Nardelli P, Kaufmann G, Braito M, Brunner A. External validation of the Tyrolean hip arthroplasty registry. J Exp Orthop. 2022 Aug 30;9(1):87. doi: 10.1186/s40634-022-00526-3.'}]}, 'descriptionModule': {'briefSummary': 'A total of 250 total hip arthroplasties (THA) are performed at the Bezirkskrankenhaus St. Johann. In a majority of those, implants from the company Falcon Medical (Austria) are used. Those implants are undergoing constant development and improvement. To guarantee their clinical performance, this clinical study is evaluating safety and efficacy of all implants produced by Falcon Medical.\n\nThe purpose of this study is to evaluate the effcacy and safety of implants produced and distributed by Falcon Medical. All patients with primary THA and usage of a Falcon Medical implant are included. The outcome measures include intra-operative complications, early post-operative complications, revision for any cause and patient reported outcome (WOMAC questionnaire). All data is prospectively collected in a standardized fashion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient treated with primary total hip arthroplasty at this department are included.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary total hip arthroplasty with the PROMIS stem\n\nExclusion Criteria:\n\n* n/a'}, 'identificationModule': {'nctId': 'NCT05734651', 'briefTitle': 'PROMIS Evaluation Study', 'organization': {'class': 'OTHER', 'fullName': 'Bezirkskrankenhaus St. Johann in Tirol'}, 'officialTitle': 'Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': '1297/2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention', 'interventionNames': ['Device: PROMIS Stem']}], 'interventions': [{'name': 'PROMIS Stem', 'type': 'DEVICE', 'description': 'Primary Total Hip Arthroplasty with the PROMIS Stem (Fa. Falcon Medical, Mödling, Austria)', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6380', 'city': 'Sankt Johann in Tirol', 'state': 'Tyrol', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Moritz Wagner, Dr. med. univ.', 'role': 'CONTACT', 'email': 'moritz.wagner@khsj.at', 'phone': '+4367762930592'}, {'name': 'Alexander Brunner, Priv.-Doz. Dr. med. univ.', 'role': 'CONTACT', 'email': 'alexander.brunner@khsj.at', 'phone': '+435352 6068780'}], 'facility': 'BKH St. Johann in Tirol, Department for Orthopedics and Traumatology', 'geoPoint': {'lat': 47.5233, 'lon': 12.4232}}], 'centralContacts': [{'name': 'Moritz Wagner, MD', 'role': 'CONTACT', 'email': 'moritz.wagner@khsj.at', 'phone': '+4350536608167'}, {'name': 'Hannes Schönthaler, MD', 'role': 'CONTACT', 'email': 'hannes.schönthale@khsj.at', 'phone': '+435356608369'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezirkskrankenhaus St. Johann in Tirol', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tyrolean Arthroplasty Registry', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Moritz Wagner', 'investigatorAffiliation': 'Bezirkskrankenhaus St. Johann in Tirol'}}}}