Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:20 PM
Study NCT ID:
NCT04748458
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
2020-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty Due to Congenital Hip Pathologies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006617', 'term': 'Hip Dislocation'}, {'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'francescocastagnini@hotmail.it', 'phone': '+390516366418', 'title': 'Dr Francesco Castagnini', 'organization': 'IRCCS Istituto Ortopedico Rizzoli'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '15 months', 'eventGroups': [{'id': 'EG000', 'title': 'Congenital Hip Pathologies', 'description': 'Conical tapered stem for osteoarthritis due to congenital hip pathologies\n\nConical tapered stem: Implantation of conical tapered stem', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 0, 'seriousNumAtRisk': 85, 'deathsNumAffected': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Harris Hip Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}, {'units': 'hip', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Congenital Hip Pathologies', 'description': 'Conical tapered stem for osteoarthritis due to congenital hip pathologies\n\nConical tapered stem: Implantation of conical tapered stem'}], 'classes': [{'categories': [{'measurements': [{'value': '89.8', 'spread': '6.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 months', 'description': 'Mean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hip', 'denomUnitsSelected': 'hip', 'populationDescription': 'Total hip arthroplasties with a Wagner Cone implant in dysplasia'}, {'type': 'PRIMARY', 'title': 'Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}, {'units': 'hip', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Congenital Hip Pathologies', 'description': 'Conical tapered stem for osteoarthritis due to congenital hip pathologies\n\nConical tapered stem: Implantation of conical tapered stem'}], 'classes': [{'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '92.5', 'upperLimit': '99.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 months', 'description': 'Percentage of survived implants (no component exchange or removed) described using Kaplan-Meier curve with 95% confidence interval. Minimum-maximum values: 0-100. Best result: 100.', 'unitOfMeasure': 'percentage of surviving hips', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hip', 'denomUnitsSelected': 'hip', 'populationDescription': 'Total hip arthroplasties with a Wagner Cone implant in dysplasia'}, {'type': 'PRIMARY', 'title': 'Radiographic Cup Osseointegration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}, {'units': 'hip', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Congenital Hip Pathologies', 'description': 'Conical tapered stem for osteoarthritis due to congenital hip pathologies\n\nConical tapered stem: Implantation of conical tapered stem'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '15 months', 'description': "Osseointegrated cups described using the Moore's criteria: the cup is osseointegrated when at least 3 criteria are present (radial trabeculae, superolateral buttress, inferolateral buttress, medial stress shielding, absence of radiolucent lines).", 'unitOfMeasure': 'hip', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hip', 'denomUnitsSelected': 'hip', 'populationDescription': 'Total hip arthroplasties with a Wagner Cone implant in dysplasia'}, {'type': 'PRIMARY', 'title': 'Radiographic Stem Osseointegration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}, {'units': 'hip', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Congenital Hip Pathologies', 'description': 'Conical tapered stem for osteoarthritis due to congenital hip pathologies\n\nConical tapered stem: Implantation of conical tapered stem'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '15 months', 'description': "Osseointegrated stems described according to Engh's criteria", 'unitOfMeasure': 'hip', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hip', 'denomUnitsSelected': 'hip', 'populationDescription': 'Total hip arthroplasties with a Wagner Cone implant in dysplasia'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Congenital Hip Pathologies', 'description': 'Conical tapered stem for osteoarthritis due to congenital hip pathologies\n\nConical tapered stem: Implantation of conical tapered stem'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '100', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '100', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'hip'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}]}, {'units': 'hip', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Congenital Hip Pathologies', 'description': 'Conical tapered stem for osteoarthritis due to congenital hip pathologies\n\nConical tapered stem: Implantation of conical tapered stem'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.9', 'spread': '11.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '85', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Crowe I', 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'description': 'Hips classified according to the Crowe dislocation degree (scale from 1, minimal subluxation, to 4, high riding hip)', 'unitOfMeasure': 'hip', 'denomUnitsSelected': 'hip'}, {'title': 'Crowe II', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'description': 'Hips classified according to the Crowe dislocation degree (scale from 1, minimal subluxation, to 4, high riding hip)', 'unitOfMeasure': 'hip', 'denomUnitsSelected': 'hip'}, {'title': 'Crowe III', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'description': 'Hips classified according to the Crowe dislocation degree (scale from 1, minimal subluxation, to 4, high riding hip)', 'unitOfMeasure': 'hip', 'denomUnitsSelected': 'hip'}, {'title': 'Crowe IV', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'description': 'Hips classified according to the Crowe dislocation degree (scale from 1, minimal subluxation, to 4, high riding hip)', 'unitOfMeasure': 'hip', 'denomUnitsSelected': 'hip'}], 'typeUnitsAnalyzed': 'hip'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-18', 'size': 91916, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-18T05:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-21', 'studyFirstSubmitDate': '2020-10-27', 'resultsFirstSubmitDate': '2021-10-05', 'studyFirstSubmitQcDate': '2021-02-06', 'lastUpdatePostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-21', 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Harris Hip Score', 'timeFrame': '15 months', 'description': 'Mean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.'}, {'measure': 'Survival Rate', 'timeFrame': '15 months', 'description': 'Percentage of survived implants (no component exchange or removed) described using Kaplan-Meier curve with 95% confidence interval. Minimum-maximum values: 0-100. Best result: 100.'}, {'measure': 'Radiographic Cup Osseointegration', 'timeFrame': '15 months', 'description': "Osseointegrated cups described using the Moore's criteria: the cup is osseointegrated when at least 3 criteria are present (radial trabeculae, superolateral buttress, inferolateral buttress, medial stress shielding, absence of radiolucent lines)."}, {'measure': 'Radiographic Stem Osseointegration', 'timeFrame': '15 months', 'description': "Osseointegrated stems described according to Engh's criteria"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysplasia; Hip', 'Prosthesis Survival']}, 'referencesModule': {'references': [{'pmid': '28291651', 'type': 'RESULT', 'citation': 'Greber EM, Pelt CE, Gililland JM, Anderson MB, Erickson JA, Peters CL. Challenges in Total Hip Arthroplasty in the Setting of Developmental Dysplasia of the Hip. J Arthroplasty. 2017 Sep;32(9S):S38-S44. doi: 10.1016/j.arth.2017.02.024. Epub 2017 Feb 22.'}, {'pmid': '22819165', 'type': 'RESULT', 'citation': 'Perry KI, Berry DJ. Femoral considerations for total hip replacement in hip dysplasia. Orthop Clin North Am. 2012 Jul;43(3):377-86. doi: 10.1016/j.ocl.2012.05.010.'}, {'pmid': '17906591', 'type': 'RESULT', 'citation': 'Argenson JN, Flecher X, Parratte S, Aubaniac JM. Anatomy of the dysplastic hip and consequences for total hip arthroplasty. Clin Orthop Relat Res. 2007 Dec;465:40-5. doi: 10.1097/BLO.0b013e3181576052.'}, {'pmid': '18725674', 'type': 'RESULT', 'citation': 'Pak P, de Steiger R. Cone femoral prosthesis for osteoarthritis of the hip with femoral dysplasia. J Orthop Surg (Hong Kong). 2008 Aug;16(2):206-10. doi: 10.1177/230949900801600216.'}, {'pmid': '28110848', 'type': 'RESULT', 'citation': 'Taniguchi N, Jinno T, Koga D, Hagino T, Okawa A, Haro H. Cementless Hip Stem Anteversion in the Dysplastic Hip: A Comparison of Tapered Wedge vs Metaphyseal Filling. J Arthroplasty. 2017 May;32(5):1547-1552. doi: 10.1016/j.arth.2016.12.020. Epub 2016 Dec 22.'}]}, 'descriptionModule': {'briefSummary': 'A retrospective consecutive population of patients treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies will be selected. The aim of this retrospective study is to evaluate the long-term clinical and radiographic results of this implant and the survival rates in such a specific cohort.', 'detailedDescription': 'Congenital hip pathologies may severely alter the local anatomy of the hip, making total hip arthroplasty (THA) due to osteoarthritis after congenital hip pathologies challenging. While it seems that congenital hip pathologies did not significantly influence the outcomes when compared to THA after osteoarthritis, the choice of implant was demonstrated to impact the survival rates of the THA after congenital hip pathologies.\n\nTo date, no guidelines exist about the correct choice of hip implant in congenital hip pathologies: only mid-term case series are available. Conical tapered stems have been frequently suggested for the most difficult cases.\n\nThe aim of this study is to describe the survival rates and the long-term clinical and radiological outcome of conical tapered stems in THAs after congenital hip pathologies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'retrospective, consecutive adult population treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic hip osteoarthritis due to congenital hip pathologies\n* Consecutive population with a minimum follow-up of 2 years\n* Cementless total hip arthroplasty with conical tapered stem\n* Pre-operative planning using CT\n* Complete clinical and radiographic assessment\n\nExclusion Criteria:\n\n* Other type of hip osteoarthritis\n* Other type of implants\n* Inadequate pre-operative planning (eg: no CT)\n* Incomplete clinical and radiographic assessment'}, 'identificationModule': {'nctId': 'NCT04748458', 'acronym': 'RetroCone', 'briefTitle': 'Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty Due to Congenital Hip Pathologies', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Retrospective Study About the Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty for Osteoarthritis Due to Congenital Hip Pathologies', 'orgStudyIdInfo': {'id': '589/2020/Oss/IOR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Congenital hip pathologies', 'description': 'Conical tapered stem for osteoarthritis due to congenital hip pathologies', 'interventionNames': ['Device: Conical tapered stem']}], 'interventions': [{'name': 'Conical tapered stem', 'type': 'DEVICE', 'description': 'Implantation of conical tapered stem', 'armGroupLabels': ['Congenital hip pathologies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Francesco Traina, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS Istituto Ortopedico Rizzoli, Bologna, ITaly'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}