Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-28 @ 1:53 PM
Study NCT ID:
NCT06096168
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2023-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical@serf.fr', 'phone': '0472056010', 'title': 'Sponsor', 'organization': 'SERF'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Until >4-years follow up (maximum duration of 90 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Per Protocol Population', 'description': 'All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 1, 'seriousNumAtRisk': 42, 'deathsNumAffected': 30, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Greater trochanter fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Posterior dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Femoral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture with greater trochanter displacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survival Rate at Mid Term Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'number of implants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per Protocol Population', 'description': 'All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between 4 to 7 years after surgery', 'description': 'Assess the survival rate, at least 4 year-follow-up, whatever the cause of revision. Cumulative survival rate expressed in percentage of implants not revised (remaining in place) using Kaplan Meier calculation.', 'unitOfMeasure': 'percentage of implant survival', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of implants', 'denomUnitsSelected': 'number of implants'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}, {'units': 'hips implanted', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per Protocol Population', 'description': 'All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria'}], 'classes': [{'title': 'Sepsis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Greater trochanter fracture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Posterior dislocation - vicious attitude of the hip', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Femoral fracture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fracture with greater trochanter displacement', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From per operative period to 4/6 years after surgery', 'description': "List type and frequency of complications, investigated by clinical and radiological examination following investigator's usual practice", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips implanted', 'denomUnitsSelected': 'hips implanted'}, {'type': 'SECONDARY', 'title': 'Survival Rates at Mid Term Follow-up (by Component)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}, {'units': 'number of hips', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per Protocol Population Implanted With NOVAE COPTOS Femoral Cup', 'description': 'All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria and with NOVAE COPTOS femoral cup'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 4/6 years after surgery', 'description': 'Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding each component of the prothesis', 'unitOfMeasure': 'percentage of implant survival', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of hips', 'denomUnitsSelected': 'number of hips'}, {'type': 'SECONDARY', 'title': 'Survival Rates at Mid Term Follow-up (by Etiology)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}, {'units': 'hips implanted', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Population Concerned by Revision + Osteosynthesis With Wires', 'description': 'All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria concerned by Revision + osteosynthesis with wires'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 4/6 years after surgery', 'description': 'Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding etiology.\n\nPercentage of patients with implant in place dispatched following reason for implantation', 'unitOfMeasure': 'percentage of implant', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips implanted', 'denomUnitsSelected': 'hips implanted'}, {'type': 'SECONDARY', 'title': "Patient's Satisfaction", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'hips implanted', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per Protocol Population', 'description': 'All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Rather satisfied', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied nor unsatisfied', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Rather unsatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Very unsatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 4/6 years after surgery', 'description': 'Assessed by the surgeon through questionary with a 5 item-scale : very satisfied / satisfied / neither satisfied - nor unsatisfied / unsatisfied / very unsatisfied', 'unitOfMeasure': 'number of hips', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips implanted', 'denomUnitsSelected': 'hips implanted'}, {'type': 'SECONDARY', 'title': 'Oblivion of Prosthesis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}, {'units': 'hips implanted', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per Protocol Population', 'description': 'All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '80.4', 'spread': '10.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 4/6 years after surgery', 'description': 'Assess the degree of forgetfulness of the prosthesis using FJS-score (Forgotten Joint Score) :\n\nFJS stands for Forgotten Joint Score. The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips implanted', 'denomUnitsSelected': 'hips implanted'}, {'type': 'SECONDARY', 'title': 'Functional Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}, {'units': 'hips implanted', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per Protocol Population', 'description': 'All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '71.5', 'spread': '21.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 4/6 years after surgery', 'description': 'Evaluate pain, walking, limping and activities of daily life using Harris Hip Score :\n\nThe global Harris Hip Score consists of a 0 to 100 points scale (100 points is the better outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'hips implanted', 'denomUnitsSelected': 'hips implanted'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Per Protocol Population', 'description': 'All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria. All patients are included in the same arm. No randomization, no control arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number of unit is corresponding to : Operated Hips', 'groupId': 'FG000', 'numUnits': '42', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Number of unit is corresponding to : Operated Hips', 'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '32', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'Revision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'typeUnitsAnalyzed': '42'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}, {'units': 'number of implants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Per Protocol Population', 'description': 'All patients implanted with a SAGITTA EVLR revision stem in CHU Rouen between 2016 and 2018 meeting inclusion/exclusion criteria'}], 'measures': [{'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}, {'units': 'number of implants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '80.4', 'spread': '8.24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}, {'units': 'number of implants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}, {'units': 'number of implants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}]}, {'units': 'number of implants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '72.8', 'spread': '19.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Weight not available for 3 patients (3 hips)'}], 'typeUnitsAnalyzed': 'number of implants'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2022-12-21', 'size': 913100, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-02T09:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2023-10-17', 'resultsFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2023-10-17', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-06', 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival Rate at Mid Term Follow-up', 'timeFrame': 'Between 4 to 7 years after surgery', 'description': 'Assess the survival rate, at least 4 year-follow-up, whatever the cause of revision. Cumulative survival rate expressed in percentage of implants not revised (remaining in place) using Kaplan Meier calculation.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'From per operative period to 4/6 years after surgery', 'description': "List type and frequency of complications, investigated by clinical and radiological examination following investigator's usual practice"}, {'measure': 'Survival Rates at Mid Term Follow-up (by Component)', 'timeFrame': 'At 4/6 years after surgery', 'description': 'Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding each component of the prothesis'}, {'measure': 'Survival Rates at Mid Term Follow-up (by Etiology)', 'timeFrame': 'At 4/6 years after surgery', 'description': 'Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding etiology.\n\nPercentage of patients with implant in place dispatched following reason for implantation'}, {'measure': "Patient's Satisfaction", 'timeFrame': 'At 4/6 years after surgery', 'description': 'Assessed by the surgeon through questionary with a 5 item-scale : very satisfied / satisfied / neither satisfied - nor unsatisfied / unsatisfied / very unsatisfied'}, {'measure': 'Oblivion of Prosthesis', 'timeFrame': 'At 4/6 years after surgery', 'description': 'Assess the degree of forgetfulness of the prosthesis using FJS-score (Forgotten Joint Score) :\n\nFJS stands for Forgotten Joint Score. The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities'}, {'measure': 'Functional Improvement', 'timeFrame': 'At 4/6 years after surgery', 'description': 'Evaluate pain, walking, limping and activities of daily life using Harris Hip Score :\n\nThe global Harris Hip Score consists of a 0 to 100 points scale (100 points is the better outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Hip Prosthesis Revision'], 'conditions': ['Hip Arthropathy']}, 'descriptionModule': {'briefSummary': 'This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. In order to reflect current practice, a comprehensive and continuous series of patients will be included.\n\nThis study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subjects who needed a revision of total hip arthroplasty, implanted with a SAGITTA EVL-R revision femoral stem according to instructions for use, over a period of time between 31/01/2016 and 31/12/2018.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient over 18 years old at the time of surgery,\n* Patient implanted with a SAGITTA EVL R revision femoral stem within its indications between 01/01/2016 and 31/12/2018,\n* Affiliated to French health insurance system\n\nExclusion Criteria:\n\n* Patient who has not expressed consent for data collection and participation in the study,\n* Patient unable to understand the surgeon's instructions or to perform postoperative follow-up.\n* Patient with a contraindication to the use of the SAGITTA EVL R revision femoral stem\n* Patient implanted with a SAGITTA EVL R revision femoral stem outside its indication"}, 'identificationModule': {'nctId': 'NCT06096168', 'acronym': '2022-10', 'briefTitle': 'Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems', 'organization': {'class': 'INDUSTRY', 'fullName': 'Societe dEtude, de Recherche et de Fabrication'}, 'officialTitle': 'Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems', 'orgStudyIdInfo': {'id': '2022-10_Sagitta EVL-R'}}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Rouen', 'state': 'Seine Maritime', 'country': 'France', 'facility': 'Centre Hospitalier de Rouen - Hôpital Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Societe dEtude, de Recherche et de Fabrication', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}