Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT05672069
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2023-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005534', 'term': 'Foot Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}, {'id': 'D001174', 'term': 'Arthrodesis'}, {'id': 'D010027', 'term': 'Osteotomy'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical@serf.fr', 'phone': '+33 4.72.05.60.10', 'title': 'Sponsor', 'organization': 'SERF'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This investigation had planned to collect 320 patients (40 per surgeon). However, the amount of data collected for FAST plates (and associated screws), VEOFIX screws and Toe FAST is limited due to a lack of inclusion or an overestimation of the capacity of the investigation.'}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Total Cohort', 'description': 'The adverse event occurred in an implanted foot.', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 16, 'seriousNumAtRisk': 121, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Persistent / residual pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Screws protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of correction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scar disunion (poor effectiveness of meching)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Locking default between locking screws /plate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stiff joint (hallux positioning problem)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Persistent pain (consolidation with screw protrusion)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthrodesis pseudarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-operative neurological disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Screw protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Reduction of the Patient's Pain and Restoration of Walking", 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Cohort', 'description': 'The description will be carried out on the whole population really included'}], 'classes': [{'title': 'Preoperatively', 'categories': [{'measurements': [{'value': '42.46', 'spread': '15.25', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '88.44', 'spread': '13.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': "The information will be collected through AOFAS (American Orthopaedic Foot and Ankle Society) score (\\>80 points) at 12 months. This score is assessed using a questionnaire measuring the patient's pain, function and alignment of the foot. This score range from 0 (worst score) to 100 (best score). The score is interpreted as follows :\n\nBetween 90-100 points : excellent results Between 80-89 points : good results Between 60-79 points : fair results Less than 60 points : poor results This score is composed of 3 sub-scores : (i) Pain score is ranging from 0 to 40 points ; Function score is ranging from 0 to 45 points ; Alignment is ranging from 0 to 15 points.", 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Cohort', 'description': 'The description will be carried out on the whole population really included'}], 'classes': [{'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Determination of the Kaplan-Meier type survival curve, with any revision as the endpoint whatever the cause. At each inflection point, a revision surgery with removal or revision surgery with removal or change of a component of the implant under consideration All causes of revision are considered. Patients who have died or been lost to follow-up will be included in the analysis.', 'unitOfMeasure': 'percentage of implant survivorship', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Foot Bone Consolidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Cohort', 'description': 'The description will be carried out on the whole population really included'}], 'classes': [{'title': 'Total', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}, {'title': 'Partial', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'No consolidation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Not determined', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The information will be collected through investigator\'s question : "on radiographic reading, is the foot bone consolidation satisfactory? : 4 answers are proposed: "total / partial / null / no information".', 'unitOfMeasure': 'Number of foot', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Cohort', 'description': 'The description will be carried out on the whole population really included'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Neither satisfied nor unsatisfied', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Unsatisfied', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The information will be collected through patient\'s question : "Considering your expectations, are you satisfied with your operation?" 4 answers are proposed: "I am completely satisfied with the results of my operation results of my operation / My condition has not improved as much as I had hoped, but I but I would be willing to have the same operation for the same result / The operation improved my condition, but I would not be prepared to have the same operation for the same result / My condition is the same or worse than before my operation than before my operation".', 'unitOfMeasure': 'Number of foot', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Cohort', 'description': 'The description will be carried out on the whole population really included'}], 'classes': [{'title': 'Discomfort', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Pseudoarthrosis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Screw protrusion', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Persistent pain (consolidation with screw protrusion)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Post-operative neurological disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Stiff joint (hallux positioning problem)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Loss of correction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Scar disunion (poor effectiveness of meching)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Locking default between locking screws/plate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Peroperative to 12 months', 'description': 'Type and occurrence of adverse events', 'unitOfMeasure': 'Number of foot', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Cohort', 'description': 'The description will be carried out on the whole population really included'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Implant removal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Cohort', 'description': 'The description will be carried out on the whole population really included'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.20', 'spread': '12.89', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '99', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'French nationality', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Operated foot side', 'classes': [{'title': 'Right', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}, {'title': 'Left', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Number of foot'}, {'title': 'Foot position', 'classes': [{'title': 'Front of foot', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}]}]}, {'title': 'Middle of foot', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Front + Middle of foot', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Back of foot', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Number of foot'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '66.72', 'spread': '14.12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height of participant (cm)', 'classes': [{'categories': [{'measurements': [{'value': '165.85', 'spread': '7.23', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2022-11-10', 'size': 124633, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-09T04:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2023-01-03', 'resultsFirstSubmitDate': '2024-09-11', 'studyFirstSubmitQcDate': '2023-01-03', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-22', 'studyFirstPostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Reduction of the Patient's Pain and Restoration of Walking", 'timeFrame': '12 months', 'description': "The information will be collected through AOFAS (American Orthopaedic Foot and Ankle Society) score (\\>80 points) at 12 months. This score is assessed using a questionnaire measuring the patient's pain, function and alignment of the foot. This score range from 0 (worst score) to 100 (best score). The score is interpreted as follows :\n\nBetween 90-100 points : excellent results Between 80-89 points : good results Between 60-79 points : fair results Less than 60 points : poor results This score is composed of 3 sub-scores : (i) Pain score is ranging from 0 to 40 points ; Function score is ranging from 0 to 45 points ; Alignment is ranging from 0 to 15 points."}], 'secondaryOutcomes': [{'measure': 'Survival Rate', 'timeFrame': '12 months', 'description': 'Determination of the Kaplan-Meier type survival curve, with any revision as the endpoint whatever the cause. At each inflection point, a revision surgery with removal or revision surgery with removal or change of a component of the implant under consideration All causes of revision are considered. Patients who have died or been lost to follow-up will be included in the analysis.'}, {'measure': 'Foot Bone Consolidation', 'timeFrame': '12 months', 'description': 'The information will be collected through investigator\'s question : "on radiographic reading, is the foot bone consolidation satisfactory? : 4 answers are proposed: "total / partial / null / no information".'}, {'measure': 'Patient Satisfaction', 'timeFrame': '12 months', 'description': 'The information will be collected through patient\'s question : "Considering your expectations, are you satisfied with your operation?" 4 answers are proposed: "I am completely satisfied with the results of my operation results of my operation / My condition has not improved as much as I had hoped, but I but I would be willing to have the same operation for the same result / The operation improved my condition, but I would not be prepared to have the same operation for the same result / My condition is the same or worse than before my operation than before my operation".'}, {'measure': 'Adverse Event', 'timeFrame': 'Peroperative to 12 months', 'description': 'Type and occurrence of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Foot Diseases']}, 'descriptionModule': {'briefSummary': "This clinical investigation was led as a post-marketing clinical follow-up study conducted as part of standard care with an additional, non-invasive, non-invasive procedure (Case 4.1) ambispective, multicentre, open-label, non-comparative.\n\nThe primary objective of this study is to evaluate the reduction in patient pain and the restoration of walking. The study will also collect performance and safety data to assess the subject's outcomes and functional status.\n\nThe target population for this study was any adult patient implanted with FAST screws, FAST plates, Toe FAST and VEOFIX screws between november 2021 and october 2022.\n\nThe investigation will be conducted in accordance with the investigation protocol, the laws and regulations (including the Medical regulations (including the Medical Devices Regulation 2017/745) and the ISO 14155:2020, as well as in accordance with the ethical principles described in the Declaration of Helsinki. The collection of personal data will also be compliant with RGPD 2016/679."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men or women of legal age, for whom one of the devices is implanted according to the instructions for use. These patients will be monitored according to standard care. As the series is observational and has an additional procedure that is neither burdensome nor invasive, all implanted patients will be considered.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subject of legal age at the date of implantation;\n* Subject implanted with one or more implants: FAST Screw, FAST Plate, Toe FAST and VEOFIX Screw between November 2021 and October 2022;\n* Subject able to understand the information and instructions given by the investigator;\n* Subject with a social security affiliation.\n\nExclusion Criteria:\n\n* Vulnerable persons\n* People with contraindications (including pregnant women)'}, 'identificationModule': {'nctId': 'NCT05672069', 'briefTitle': 'Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices', 'organization': {'class': 'INDUSTRY', 'fullName': 'Societe dEtude, de Recherche et de Fabrication'}, 'officialTitle': 'Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices', 'orgStudyIdInfo': {'id': '2021-08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Osteosynthesis', 'type': 'PROCEDURE', 'otherNames': ['Arthrodesis', 'Osteotomy'], 'description': 'Foot pathologies'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33600', 'city': 'Pessac', 'country': 'France', 'facility': 'Hôpital Privé Saint-Martin', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Societe dEtude, de Recherche et de Fabrication', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}