Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT05821920
Status:
UNKNOWN
Last Update Posted:
2024-05-01
First Post:
2023-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety Study on Posterior Pedicle Screw System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D000081084', 'term': 'Accidental Injuries'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-06-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2023-04-04', 'studyFirstSubmitQcDate': '2023-04-18', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of MUST MINI system safety', 'timeFrame': '24 months', 'description': 'collection of adverse event'}], 'secondaryOutcomes': [{'measure': 'Clinical outcomes', 'timeFrame': 'preop, 6 weeks, 6 months, 12 months', 'description': 'mJOA questionnaire, a 18-point investigator-administered scale separately addresses motor dysfunction of the upper extremity (MDUE) and motor dysfunction of the lower extremity (MDLE), sensory loss of the upper extremity, and sphincter dysfunction (SD). Severe myelopathy (0-11), moderate myelopathy (12-14), mild myelopahty (15-17).'}, {'measure': 'Clinical outcomes', 'timeFrame': 'preop, 6 weeks, 6 months, 12 months', 'description': 'NDI questionnaire. Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.\n\n0-4points (0-8%) no disability, 5-14points ( 10 - 28%) mild disability, 15-24points (30-48% ) moderate disability, 25-34points (50- 64%) severe disability, 35-50points (70-100%) complete disability'}, {'measure': 'Clinical outcomes', 'timeFrame': 'preop, 6 weeks, 6 months, 12 months', 'description': 'EQ-5D questionnaire consists of two section, descriptive and a visual analog scale to describe the own health status. The score is calculated by assigning a numerical value to each response level (i.e., 1 for "no problems", 5 for "extreme problems"/"unable to") and summing these values across the five items, resulting in a score from 5 to 25.'}, {'measure': 'Clinical outcomes', 'timeFrame': 'preop, 6 weeks, 6 months, 12 months', 'description': "VAS pain scale measure the pain intensity with a scale from 0 ('no pain') to 10 ('pain as bad as it could possibly be')."}, {'measure': 'Bone fusion at index level', 'timeFrame': '12 month', 'description': 'For each level a CT examination will be performed in order to define if bone fusion is or not. The presence or absence of bridging trabecular bone across the segment can identify is reported.'}, {'measure': 'Cervical spine functionality', 'timeFrame': 'Immediate postop, 6 weeks, 12 months', 'description': 'Sandard functional x-ray is performed in order to measure the segmental range of motion in the lumbar spine during flexion-extension with the purpose of gathering additional data for the diagnosis of instability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease', 'Trauma Injury', 'Tumor']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to assess the MUST MINI system safety in patient who will undergo a posterior cervical spine fusion intervention. Patients will be invited to partecipate during preoperative visit and follow the postoperative visits according to the standard practice.', 'detailedDescription': "Patient who will undergo a posterior cervical spine fusion intervention, will be invited during preoperative visit to take part to the study.\n\nThe study is an observational multicentric study with an enrolment period of 12 months with the aim to assess the safety of MUST MINI system.\n\nAll adverse events will be collected for all study duration, classified as device and not device related. Screw failure rate is calculated considering screw loosening, breakage, lost-reduction events.\n\nStandard radiological investigations are previewed at preoperative visit, before discharge and at 6 weeks and 12 months follow-up after surgery visits; the risk of any further exposure to radiation other than it's routine use in a diagnostic manner within the follow-up period can be excluded.\n\nA final visit at 12 months level index fusion will be evaluated clinically as well as radiographically, with a confirmation CT scan as per standard of care. Screw placement accuracy will be evaluated during this visit.\n\nA functional cervical x-ray is considered also during last follow-up (12 months after surgery) in order to assess cervical spine functionality."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who will undergo a posterior cervical spine fusion with MUST MINI system and respecting the inclusion criteria will be invited to participate to the study during the preoperative visit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* those affected by degenerative disc disease needing a posterior surgical instrumented treatment aimed at segmental fusion,\n* those who will undergo posterior fixation due to traumatic lesion or tumor,\n* Patients with BMI ≤ 35 kg/m2,\n* those who signed the consent form to participate to the study.\n\nExclusion Criteria:\n\n* Patients \\<18 years,\n* Patients who are pregnant or intend to become pregnant during the study.'}, 'identificationModule': {'nctId': 'NCT05821920', 'acronym': 'MUST MINI PMS', 'briefTitle': 'A Safety Study on Posterior Pedicle Screw System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta International SA'}, 'officialTitle': 'Prospective Multicentric Clinical Study to Assess Safety of MUST MINI Posterior Cervical System.', 'orgStudyIdInfo': {'id': 'P05.008.01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MUST MINI system', 'type': 'DEVICE', 'description': 'cervical posterior fixation system'}]}, 'contactsLocationsModule': {'locations': [{'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jens Lehmberg, Prof Dr', 'role': 'CONTACT', 'email': 'neurochirugie@muenchen-klinik.de', 'phone': '089/9270-2021'}], 'facility': 'München Klinik Bogenhausen', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'centralContacts': [{'name': 'Elisa Bonacina, PhD', 'role': 'CONTACT', 'email': 'bonacina@medacta.ch', 'phone': '+41 91 696 60 60'}], 'overallOfficials': [{'name': 'Jens Lehmberg, Prof Med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'München Klinik Bogenhausen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}