Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-03-08 @ 1:50 AM
Study NCT ID:
NCT03369158
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2017-11-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pedicle Screw Positioning With MySpine vs Free Hand Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bonacina@medacta.ch', 'phone': '+41 91 696 60 60', 'title': 'Clinical Data Manager', 'organization': 'Medacta International'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'MySpine', 'description': 'Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"\n\npatient specific pedicle screw positioning guide\n\nMUST pedicle screw', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Free Hand Technique', 'description': 'Patients operated for spinal stabilization through standard free hand technique\n\nFree hand technique pedicle screw positioning\n\nMUST pedicle screw', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accuracy of Pedicle Screw Positioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'screw', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MySpine', 'description': 'Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"\n\npatient specific pedicle screw positioning guide\n\nMUST pedicle screw'}, {'id': 'OG001', 'title': 'Free Hand Technique', 'description': 'Patients operated for spinal stabilization through standard free hand technique\n\nFree hand technique pedicle screw positioning\n\nMUST pedicle screw'}], 'classes': [{'categories': [{'measurements': [{'value': '90.24', 'groupId': 'OG000', 'lowerLimit': '86.86', 'upperLimit': '93.6'}, {'value': '83.13', 'groupId': 'OG001', 'lowerLimit': '78.42', 'upperLimit': '87.84'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week after surgery', 'description': 'Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle.', 'unitOfMeasure': 'percentage of screw', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'screw', 'denomUnitsSelected': 'screw'}, {'type': 'SECONDARY', 'title': 'Radiological Evaluation of Pedicle Screw Malposition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'screws', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MySpine', 'description': 'Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"\n\npatient specific pedicle screw positioning guide\n\nMUST pedicle screw'}, {'id': 'OG001', 'title': 'Free Hand Technique', 'description': 'Patients operated for spinal stabilization through standard free hand technique\n\nFree hand technique pedicle screw positioning\n\nMUST pedicle screw'}], 'classes': [{'categories': [{'title': 'Group 0', 'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}, {'title': 'Group A', 'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Group B', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Group C', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '1 weeks after surgery', 'description': 'A CT will be performed before discharge to evaluate the severity of pedicle screws malposition according to Gertzbein in grades 0, A, B or C, with grades 0 or A considered as "safe area.". Level 0 (perfect corrected positioning of the screw), level A (0-2 mm of violation), level B (2-4 mm of violation), level C (˃4mm of violation). The better outcomes correspond to level 0 and the worst to level C.', 'unitOfMeasure': 'screws', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'screws', 'denomUnitsSelected': 'screws'}, {'type': 'SECONDARY', 'title': 'Occurrence of Malposition Side', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'screw', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MySpine', 'description': 'Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"\n\npatient specific pedicle screw positioning guide\n\nMUST pedicle screw'}, {'id': 'OG001', 'title': 'Free Hand Technique', 'description': 'Patients operated for spinal stabilization through standard free hand technique\n\nFree hand technique pedicle screw positioning\n\nMUST pedicle screw'}], 'classes': [{'title': 'Lateral misplacement', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Medial misplacement', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 weeks after surgery', 'description': 'Evaluation of malposition on the medial or lateral side', 'unitOfMeasure': 'screws', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'screw', 'denomUnitsSelected': 'screw'}, {'type': 'SECONDARY', 'title': 'Incidence of Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MySpine', 'description': 'Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"\n\npatient specific pedicle screw positioning guide\n\nMUST pedicle screw'}, {'id': 'OG001', 'title': 'Free Hand Technique', 'description': 'Patients operated for spinal stabilization through standard free hand technique\n\nFree hand technique pedicle screw positioning\n\nMUST pedicle screw'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'intraoperatively, up to 1 week after surgery', 'description': 'Occurrence of intra-operative complications reporting', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MySpine', 'description': 'Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"\n\npatient specific pedicle screw positioning guide\n\nMUST pedicle screw'}, {'id': 'FG001', 'title': 'Free Hand Technique', 'description': 'Patients operated for spinal stabilization through standard free hand technique\n\nFree hand technique pedicle screw positioning\n\nMUST pedicle screw'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MySpine', 'description': 'Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"\n\npatient specific pedicle screw positioning guide\n\nMUST pedicle screw'}, {'id': 'BG001', 'title': 'Free Hand Technique', 'description': 'Patients operated for spinal stabilization through standard free hand technique\n\nFree hand technique pedicle screw positioning\n\nMUST pedicle screw'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'spread': '15.3', 'groupId': 'BG000'}, {'value': '26', 'spread': '17.2', 'groupId': 'BG001'}, {'value': '31', 'spread': '16.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2017-11-28', 'resultsFirstSubmitDate': '2020-02-19', 'studyFirstSubmitQcDate': '2017-12-05', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-18', 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Pedicle Screw Positioning', 'timeFrame': '1 week after surgery', 'description': 'Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle.'}], 'secondaryOutcomes': [{'measure': 'Radiological Evaluation of Pedicle Screw Malposition', 'timeFrame': '1 weeks after surgery', 'description': 'A CT will be performed before discharge to evaluate the severity of pedicle screws malposition according to Gertzbein in grades 0, A, B or C, with grades 0 or A considered as "safe area.". Level 0 (perfect corrected positioning of the screw), level A (0-2 mm of violation), level B (2-4 mm of violation), level C (˃4mm of violation). The better outcomes correspond to level 0 and the worst to level C.'}, {'measure': 'Occurrence of Malposition Side', 'timeFrame': '1 weeks after surgery', 'description': 'Evaluation of malposition on the medial or lateral side'}, {'measure': 'Incidence of Adverse Event', 'timeFrame': 'intraoperatively, up to 1 week after surgery', 'description': 'Occurrence of intra-operative complications reporting'}]}, 'conditionsModule': {'conditions': ['Spinal Deformity']}, 'descriptionModule': {'briefSummary': 'Randomized clinical study in order to evaluate the accuracy of pedicle screw positioning during spine surgery performed with MySpine patient match positioning guide or Free hand technique.', 'detailedDescription': "The proposed study seeks to assess the intraoperative accuracy of the Medacta patient-specific MySpine® pedicle screws placement guides in comparison to free-hand technique.\n\nA pre-operative CT scan of the spine is obtained to create a 3-dimensional model of the patient's spine for the MySpine patient group. This model is then used to preoperatively plan the patient's surgery implantation itself, with the same goals of both free-hand and computer assisted techniques. The theoretical advantage of this technique is accurate implant placement without the added surgical time and complexity of the procedure, with lower radiation exposure thanks to less steps of fluoroscopy checks.\n\nThe hypothesis for the present study is that the MySpine® technique can place pedicle screws more accurately in comparison to free-hand technique.\n\nThe accuracy of the final implant position with respect to the pre-operative planning will be evaluated through CT post-op analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 12 years\n* patients suffering from coronal or sagittal spinal deformities that will undergo a surgical treatment with a posterior approach and pedicle screws placement\n* Patients suitable to undergo spinal stabilization (according to the label indication/contraindications)\n* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained when indication to surgery is confirmed.\n\nExclusion Criteria:\n\n* Patient with congenital spinal deformity (emeverebre, vertebra wedge, vertebrate butterfly, congenital bar, vertebra block)\n* Patients with a previous fusion of the spine in the region where screws will be inserted\n* Patients with any allergy to the device implanted\n* Patients who will be not able to provide their written consent to the study participation\n* Patients who are incapable of understanding and wanting'}, 'identificationModule': {'nctId': 'NCT03369158', 'briefTitle': 'Pedicle Screw Positioning With MySpine vs Free Hand Technique', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta International SA'}, 'officialTitle': 'A Prospective Clinical Survey on Accuracy of Pedicle Screws Positioning With MySpine Versus Free Hand Technique', 'orgStudyIdInfo': {'id': 'P05.005.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MySpine', 'description': 'Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"', 'interventionNames': ['Procedure: patient specific pedicle screw positioning guide', 'Device: MUST pedicle screw']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Free hand technique', 'description': 'Patients operated for spinal stabilization through standard free hand technique', 'interventionNames': ['Procedure: Free hand technique pedicle screw positioning', 'Device: MUST pedicle screw']}], 'interventions': [{'name': 'patient specific pedicle screw positioning guide', 'type': 'PROCEDURE', 'otherNames': ['MySpine'], 'armGroupLabels': ['MySpine']}, {'name': 'Free hand technique pedicle screw positioning', 'type': 'PROCEDURE', 'armGroupLabels': ['Free hand technique']}, {'name': 'MUST pedicle screw', 'type': 'DEVICE', 'armGroupLabels': ['Free hand technique', 'MySpine']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}