Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-04 @ 8:55 AM
Study NCT ID:
NCT04169659
Status:
UNKNOWN
Last Update Posted:
2019-11-20
First Post:
2019-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kyphoplasty With Structured Titanium Spheres
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016103', 'term': 'Spinal Fractures'}], 'ancestors': [{'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058498', 'term': 'Kyphoplasty'}], 'ancestors': [{'id': 'D054854', 'term': 'Vertebroplasty'}, {'id': 'D060826', 'term': 'Cementoplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective Rondomized Open Blinded End Point'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-10-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-16', 'studyFirstSubmitDate': '2019-07-06', 'studyFirstSubmitQcDate': '2019-11-16', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of prototype device usage, as assessed by Change from baseline in post-surgical complication rate at 1 month.', 'timeFrame': '1 month post operative control', 'description': 'Demonstrate if the prototype device is useful.'}], 'secondaryOutcomes': [{'measure': 'Visual analogical Scale (VAS) and changing in time.', 'timeFrame': 'immediate, follow-up at 1-3-6 months after trauma', 'description': 'Visual analogical Scale (VAS) from 0 to 10. Decreasing of VAS, compared to base line, will be considered a good point.'}, {'measure': 'Pre, Post operation Vertebra height and changing in time', 'timeFrame': 'immediate, follow-up at 1-3-6 months after trauma', 'description': 'Comparing Vertebra height in cm before and after surgery. Good height restoration will be considered a good point.'}, {'measure': 'Acquired kyphosis', 'timeFrame': '6 months after trauma', 'description': 'Cobb angle measurement. No angle acquisition it will be considered as a good point.'}, {'measure': 'Ostheogenesis', 'timeFrame': '6 months after trauma', 'description': 'Induced osteogenesis investigated by Bone Scintigraphy. Osteoinduction will be considered as positive point.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kyphoplasty', 'EBM', 'Titanium', 'Microsphere', 'Vertebral fracture'], 'conditions': ['Vertebral Fracture']}, 'descriptionModule': {'briefSummary': 'The aim of the trial is to study efficacy and safety of Kyphoplasty technique with porous titanium microspheres in patients with type A vertebral body fracture (according to Magerl classification).', 'detailedDescription': 'Randomized controlled open trial with P.R.O.B.E. design (Prospective Randomized Open, Blinded End-point)\n\nObjective:\n\nThe aim of the trial is to study efficacy and safety of Kyphoplasty technique with porous titanium microspheres in patients with type A vertebral body fracture (according to Magerl classification).\n\nAll consecutive eligible patients, belonging to the Neurosurgery Unit of A.R.N.A.S. Civico Hospital, in Palermo, will be included in the pilot study: 10 patients will be recruited for the treatment arm and 10 patients for the control arm.\n\n* Patients aged between 18 and 80 years.\n* Diagnosis of vertebral body fracture, type A (according to Magerl classification) in particular A.1, A.2 and A.3.1.\n* Absence of ligamentous structures lesion and / or invasion of the spinal canal, confirmed by RX TC and NMR.\n* Refusal to sign informed consent,\n* Diagnosis different from those established by inclusion criteria.\n* Age under 18 years.\n* Age over 80 years.\n* Presence of ligamentous structures lesion and / or invasion of the spinal canal confirmed by RX, TC and NMR.\n\nFor each patient will be evaluated:\n\n* Spine RX\n* CT of the spinal layer (or Spine CT)\n* Spine MRI\n* Roland Morris Disability (for the assessment of low back pain)\n* EQ-5D (health questionnaire)\n* Denis Work Scale (for the assessment of working conditions)\n* VAS (for pain assessment)\n* The statistical analysis will be performed using the SPSS software vers. 12.0 (SPSS Inc., Chicago, IL, United States). The study data will be collected pursuant to and for the purposes of articles 13 and 23 of the D. L.gs. n. 196/2003.\n\nThe study will be performed according to the rules established by the principles of Good Clinical Practice (as per Ministerial Decree of 07/15/97) and according to the principles gathered in the Helsinki Declaration (52 nd WMA General Assembly version, Edimburgh, Scotland, October 2000 ).\n\nThe clinical practices are performed according to the most recent recommendations of the World Medical Assembly (Declaration of Helsinki, 1964, and subsequent amendments).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Magerl Type A Thoracolumbar fracture with no neurological deficits\n* Age\\>18yy and \\< 80yy\n* No ligament lesions\n\nExclusion Criteria:\n\n* age \\< 18yy or \\> 80yy\n* Ligament lesions\n* refusal to sign informed consent'}, 'identificationModule': {'nctId': 'NCT04169659', 'briefTitle': 'Kyphoplasty With Structured Titanium Spheres', 'organization': {'class': 'OTHER', 'fullName': 'ARNAS Civico Di Cristina Benfratelli Hospital'}, 'officialTitle': 'Kyphoplasty With Structured Titanium Spheres: Pilot Study. P.R.O.B.E. Trial (Prospective Randomized Open Blinded End Point)', 'orgStudyIdInfo': {'id': '232 Civico 2018'}, 'secondaryIdInfos': [{'id': 'MTOrtho', 'type': 'OTHER', 'domain': 'MTOrtho'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kyphoplasty with Titanium spheres', 'description': 'Patients treated with kyphoplasty with baloons and insertion of titanium microspheres inside the body vertebra.', 'interventionNames': ['Device: Kyphoplasty with insertion of Sctructured Titanium Microspheres']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Kyphoplasty with Polymethylmethacrilate', 'description': 'Patients treated with Kyphoplasty with baloons and insertion of Polymethylmetacrylate inside the body vertebra.', 'interventionNames': ['Device: Kyphoplasty with Polimethylmetacrilate (convetional surgery)']}], 'interventions': [{'name': 'Kyphoplasty with insertion of Sctructured Titanium Microspheres', 'type': 'DEVICE', 'description': 'Under fluoroscophy, we introduce a transpeduncolar trocar inside the vertebral body where is performed a kyphoplasty with insertion of baloons. When the dome is cretated we introduce structured titanium microspheres until the dome is full of material.', 'armGroupLabels': ['Kyphoplasty with Titanium spheres']}, {'name': 'Kyphoplasty with Polimethylmetacrilate (convetional surgery)', 'type': 'DEVICE', 'description': 'Under fluoroscophy, we introduce a transpeduncolar trocar inside the vertebral body where is performed a kyphoplasty with insertion of baloons. When the dome is cretated we introduce Polimethylmetacrilate until the dome is full of material.', 'armGroupLabels': ['Kyphoplasty with Polymethylmethacrilate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90100', 'city': 'Palermo', 'state': 'PA', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gabriele Costantino', 'role': 'CONTACT', 'email': 'gabriele.costantino@arnascivico.it', 'phone': '00393339088839'}], 'facility': 'Gabriele Costantino', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}], 'centralContacts': [{'name': 'Gabriele Costantino', 'role': 'CONTACT', 'email': 'gabriele.costantino@arnascivico.it', 'phone': '3339088839', 'phoneExt': '+39'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ARNAS Civico Di Cristina Benfratelli Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gabriele Costantino', 'investigatorAffiliation': 'ARNAS Civico Di Cristina Benfratelli Hospital'}}}}