Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-31 @ 3:54 PM
Study NCT ID:
NCT06924567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-11
First Post:
2025-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiographic Stability of Hip Prosthesis Prior to Revision Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-05', 'studyFirstSubmitDate': '2025-04-05', 'studyFirstSubmitQcDate': '2025-04-05', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cup and stem stability', 'timeFrame': 'within 2 months month', 'description': 'The stability of the cup and the stem is evaluated:\n\n1. Preoperatively with IMA as binary outcome (loose/not loose).\n2. Intraoperatively by the surgeon as binary outcome (loose/notloose).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['implant stabilty', 'THA', 'radiographic evaluation', 'IMA', 'Implant Movement Analysis', 'Revision THA'], 'conditions': ['Loosening, Prosthesis', 'Hip Arthropathy']}, 'referencesModule': {'references': [{'pmid': '18622838', 'type': 'BACKGROUND', 'citation': 'Olivecrona H, Olivecrona L, Weidenhielm L, Noz ME, Kardos J, Maguire GQ Jr, Zeleznik MP, Aspelin P. A new technique for diagnosis of acetabular cup loosening using computed tomography: preliminary experience in 10 patients. Acta Orthop. 2008 Jun;79(3):346-53. doi: 10.1080/17453670710015247.'}, {'pmid': '37986000', 'type': 'BACKGROUND', 'citation': 'Lovera D, Sandberg O, Mohaddes M, Gyllensten H. Cost-effectiveness of implant movement analysis in aseptic loosening after hip replacement: a health-economic model. Cost Eff Resour Alloc. 2023 Nov 20;21(1):88. doi: 10.1186/s12962-023-00498-w.'}, {'pmid': '36314542', 'type': 'BACKGROUND', 'citation': 'Sandberg O, Carlsson S, Harbom E, Cappelen V, Tholen S, Olivecrona H, Wretenberg P. Inducible displacement CT increases the diagnostic accuracy of aseptic loosening in primary total hip arthroplasty. Acta Orthop. 2022 Oct 31;93:831-836. doi: 10.2340/17453674.2022.5240.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this validation study is to compare the preoperative implant stability, assessed by Implant Movement Analysis (IMA), provocation dual CT scans, with the intraoperative stability evaluation in revision hip arthoplasty. The main question it aims to answer is:\n\nDoes IMA reflect the intraoperative clinical evaluation of implant stability? Participants scheduled for revision hip arthoplasty will undergo IMA preoperativelly in addition to rutine clinical work up. During revision arthoplasty, a surgeon blinded to the IMA results will assess clinically the stability of the hip prosthesis. IMA will be compared with the intraoperative findings to assess IMAs sensitivity and specificity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a painful total hip arthoplasty that are scheduled for revision hip arthoplasty due to suspected prosthesis loosening. At least one implant component (either cup or stem) should not have any obvious signs of loosening. Only the implant component with no obvious signs of loosening will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria: 600 consecutive patients scheduled for revision THA due to aseptic loosening, in whom, one component has no convincing loosening signs, based on the preoperative plain radiographs and clinical assessment by the attending surgeon. The radiographs should be not older than 8 weeks prior to surgery.\n\nExclusion criteria:\n\nBoth cup and stem have been preoperatively evaluated as loose by the attending surgeon, based on the preoperative plain radiographs.\n\nInstability with repeating dislocation of the THA Non-aseptic revision surgery, based on preoperative work up. Participants are excluded after inclusion if revision surgery is cancelled.'}, 'identificationModule': {'nctId': 'NCT06924567', 'acronym': 'MULTICIMA', 'briefTitle': 'Radiographic Stability of Hip Prosthesis Prior to Revision Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'The Accuracy of CT-based Implant Movement for the Evaluation of Cup and Stem Stability, When Plain Radiography is Not Conclusive for Loosening, in Patients Scheduled for Revision Hip Arthroplasty. A Multicenter Study', 'orgStudyIdInfo': {'id': '284803'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients with painful THA, scheduled for reviision hip arthoplasty, with no signs of obvious implant loosening in either the cup or the stem.', 'interventionNames': ['Diagnostic Test: Implant motion provocation CT']}], 'interventions': [{'name': 'Implant motion provocation CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Implant Movement Analysis. A low dose CT scan is performed with the hip fixed in external rotation. Then another low dose CT scan is performed with the hip fixed in internal rotation.The CT scans are then overimposed to each other and implant motion in relation to host bone is visualized,', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'contacts': [{'name': 'Linda Andersson, BMA', 'role': 'CONTACT', 'email': 'linda.mr.andersson@vgregion.se', 'phone': '0046762756531'}, {'name': 'Georgios Tsikandylakis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Raéd Itayem, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Hässleholm', 'country': 'Sweden', 'contacts': [{'name': 'Maziar Mohaddes, MD, PhD', 'role': 'CONTACT'}, {'name': 'Maziar Mohaddes, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hässleholm Hospital', 'geoPoint': {'lat': 56.15905, 'lon': 13.76638}}, {'city': 'Stockholm', 'country': 'Sweden', 'contacts': [{'name': 'Olof Sköldenberg, MD, PhD', 'role': 'CONTACT'}, {'name': 'Olof Sköldenberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Danderyd Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Uppsala', 'country': 'Sweden', 'contacts': [{'name': 'Cyrus Brodén, MD, PhD', 'role': 'CONTACT', 'email': 'cyrus.broden@akademiska.se'}, {'name': 'Cyrus Brodén, M, PhDD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Akademiska University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Linda Andersson, BMA', 'role': 'CONTACT', 'email': 'linda.mr.andersson@vgregion.se', 'phone': '0762756531'}], 'overallOfficials': [{'name': 'Henrik Malchau, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sahlgrenska University Hospital'}, {'name': 'Georgios Tsikandylakis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgios Tsikandylakis, MD PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sectra AB, Sweden', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Georgios Tsikandylakis, MD PhD', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}