Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT05844358
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2023-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cortical Bone Trajectory With Patient Guide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-25', 'studyFirstSubmitDate': '2023-04-25', 'studyFirstSubmitQcDate': '2023-04-25', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone fusion', 'timeFrame': '6 months', 'description': 'Percentage of subjects get bone fusion at index level will be calculated'}], 'secondaryOutcomes': [{'measure': 'Pain perception', 'timeFrame': 'preop, 5 weeks, 3months, 6 months, 12 months', 'description': 'A visual analog scale will be filled to assess leg and back pain'}, {'measure': 'Functional status', 'timeFrame': 'preop, 5 weeks, 3months, 6 months, 12 months', 'description': 'ODI index questionnaire for assessing functional status and quality-of-life impairment in patients with low back pain or spinal cord disease and injury in research and clinical settings will be filled'}, {'measure': 'Quality of life', 'timeFrame': 'preop, 5 weeks, 3months, 6 months, 12 months', 'description': 'Euroqol 5D questionnaire will be collected to assess quality of life'}, {'measure': 'Safety device', 'timeFrame': 'preop, 5 weeks, 3months, 6 months, 12 months', 'description': 'collection of adverse event'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': 'The use of patient specific guides with proper preoperative planning, following a cortical bone trajectory technique, should guarantee a successful surgery and benefit of less invasive technique.\n\nThis study intends to measure the safety and efficacity of MySpine MC patient-specific guide system, when used according to its general indication of use and following the surgical technique suggested by the manufacturer', 'detailedDescription': 'Adult patients affected by degenerative disc disease, meeting all inclusion/exclusion criteria, will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit. They will be provided with an information letter and, in case of acceptance to participate to the study, asked to sign a consent form.\n\nAfter enrolment, each patient will be monitored for 13 months. Data concerning demography, preoperative clinical conditions, surgical details including device implanted and complications occurred, postoperative clinical and/or radiological assessments (as per standard routine at 5 weeks, 3, 7 and 13 months) will be prospectively collected. The level of bone fusion will be evaluated with a postoperative CT scan at 7 ±2 months follow-up'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A consecutive ongoing recruitment through study members in daily clinical practice will take place.\n\nThe 102 patients planned for this survey will be recruited by the Investigators meeting all the inclusion/exclusion criteria.\n\nSubjects, among those whose clinical condition makes them eligible for a spinal stabilization, will be invited to participate to the study. Enrolment will take place over a period of 24 months, until the forecasted number of 102 patients has entered into the survey.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. those affected by degenerative disc disease needing a surgical treatment one/two levels with posterior approach to screw fixation\n2. those who need a surgical procedure of lumbar spine stabilization according to Medacta device instruction for use from level L2 to level S1\n3. those who signed consent form to participate to the study\n4. Normal healthy patients or with mild systematic disease identified as patients with ASA score 1 or 2\n5. Patients with BMI ≤ 35 kg/m2\n6. non responsive or unsufficient resposive to non -invasive treatment such as analgesics\n\nExclusion Criteria:\n\n1. Patients affected by lytic lystesis and degenerative lystesis with grade≥2 will be excluded\n2. Patients \\<18 years\n3. Patient who is pregnant or intends to become pregnant during the study\n4. Known substance or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT05844358', 'acronym': 'MySpine MC', 'briefTitle': 'Cortical Bone Trajectory With Patient Guide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta International SA'}, 'officialTitle': 'PROSPECTIVE MULTICENTRIC CLINICAL STUDY TO ASSESS SAFETY OF A CORTICAL BONE TRAJECTORY SCREW INSERTION TECHNIQUE WITH THE USE OF PATIENT SPECIFIC DRILL GUIDES', 'orgStudyIdInfo': {'id': 'P05.007.05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MySpine MC', 'type': 'DEVICE', 'description': 'Spinal stabilization throught the support of patient specific guide, MySpine MC according to cortical bone trajectory technique'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'AZ Monica Hospital', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Turnhout', 'country': 'Belgium', 'facility': 'AZ Sint-Elisabeth Turnhout', 'geoPoint': {'lat': 51.32254, 'lon': 4.94471}}], 'overallOfficials': [{'name': 'Geert Mahieu, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AZ Monica Hospital'}, {'name': 'Patricia Verstraete, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AZ Sint-Elisabeth Turnhout'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}