Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT05023733
Status:
UNKNOWN
Last Update Posted:
2022-01-28
First Post:
2021-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Outcomes of TLIF w/3D Printed Cellular Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D013168', 'term': 'Spondylolisthesis'}, {'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-14', 'studyFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2021-08-23', 'lastUpdatePostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic Fusion', 'timeFrame': '18 months', 'description': 'Fusion success measured by radiological assessment. Evidence of fusion demonstrated by bone formation through the cage on anteroposterior (AP) and Lateral radiographs, Flexion and Extension radiographs at 18 months'}, {'measure': 'Radiographic Fusion', 'timeFrame': '24 months', 'description': 'Fusion success measured by radiological assessment. Evidence of fusion demonstrated by bone formation through the cage on anteroposterior (AP) and Lateral radiographs, Flexion and Extension radiographs at 24 months'}], 'secondaryOutcomes': [{'measure': 'Back and Leg Visual Analog Scale (VAS)', 'timeFrame': '6 months', 'description': 'Improvement in the VAS as measured by a minimum of a 20 point improvement'}, {'measure': 'Back and Leg Visual Analog Scale (VAS)', 'timeFrame': '12 months', 'description': 'Improvement in the VAS as measured by a minimum of a 20 point improvement'}, {'measure': 'Back and Leg Visual Analog Scale', 'timeFrame': '18 months', 'description': 'Improvement in the VAS as measured by a minimum of a 20 point improvement'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '6 months', 'description': 'Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) \\>20%'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '12 months', 'description': 'Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) \\>20%'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '18 months', 'description': 'Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) \\>20%'}, {'measure': 'Adverse Events', 'timeFrame': 'up to 24 months', 'description': 'Number of procedure and device related adverse events'}, {'measure': 'Intervention Rates', 'timeFrame': 'up to 24 months', 'description': 'Rates of reoperation and/or revision procedures at index level(s)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['transforaminal', 'degenerative disc disease (DDD)', 'Lumbar Fusion', 'Interbody Fusion'], 'conditions': ['Foraminal Stenosis', 'Degenerative Disc Disease', 'Lumbar Spondylolisthesis', 'Lumbar Spinal Stenosis']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate clinical outcomes and spine fusion rates for patients undergoing transforaminal lumbar interbody fusion using the CONDUIT 3D printed titanium TLIF cage.', 'detailedDescription': 'This prospective, single-center study is being conducted as a post market evaluation of the CONDUIT 3D printed titanium TLIF Cage. Patients undergoing transforaminal lumbar interbody fusions due to lumbar spinal pathology (i.e. central foraminal stenosis, degenerative disc disease, and/or lumbar spondylolisthesis) and have failed conservative care will be recruited for this study. Patients will be serially evaluated at 6 month intervals for a total of 24 months post index procedure to assess patient reported outcomes, clinical outcomes, and radiographic parameter, specifically spine fusion rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be skeletally mature adults ages 35-80 years of age undergoing one or two level transforaminal lumbar interbody fusion. These patients will have a diagnosis of lumbar degenerative disc disease with or without neurologic deficit and associated central and/or unilateral /bilateral foraminal stenosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Skeletally mature adults ages 35 - 80 years of age, inclusive\n* Diagnosis of lumbar degenerative disc disease with or without neurologic deficit and associated central and/or unilateral/bilateral foraminal stenosis\n* Subject undergoing one or two level transforaminal lumbar interbody fusion\n* Able to read and understand all documents used in this study , including the informed consent and patient-reported outcome questionnaires\n\nExclusion Criteria:\n\n* Patients over 80 years of age\n* Patients under 35 years of age\n* Current smokers\n* BMI\\>42\n* Subject has spondylolisthesis \\> 2\n* Subjects with multilevel \\>2 levels of symptomatic disease\n* Subjects with significant spinal deformity\n* Subject is pregnant, plans to become pregnant or is breast feeding'}, 'identificationModule': {'nctId': 'NCT05023733', 'briefTitle': 'Clinical and Radiographic Outcomes of TLIF w/3D Printed Cellular Implant', 'organization': {'class': 'OTHER', 'fullName': 'Hartford Hospital'}, 'officialTitle': 'Clinical and Radiographic Outcomes of Transforaminal Lumbar Interbody Fusion (TLIF) With a Novel 3D Printed Cellular Titanium Implant', 'orgStudyIdInfo': {'id': 'HHC-2020-0243'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1', 'description': 'One to two contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1 whose condition requires the use of interbody fusion.', 'interventionNames': ['Device: CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®']}], 'interventions': [{'name': 'CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®', 'type': 'DEVICE', 'otherNames': ['lumbar fusion'], 'description': 'Patients undergoing 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1', 'armGroupLabels': ['1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bethany Samperi', 'role': 'CONTACT', 'email': 'bethany.samperi@hhchealth.org', 'phone': '860-972-5978'}, {'name': 'Matthew Solomito, PhD', 'role': 'CONTACT', 'email': 'matthew.solomito@hhchealth.org', 'phone': '203-525-7659'}, {'name': 'Farhan Karim, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hartford Healthcare Bone and Joint Institute', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'centralContacts': [{'name': 'Bethany Samperi', 'role': 'CONTACT', 'email': 'bethany.samperi@hhchealth.org', 'phone': '860-972-5978'}, {'name': 'Matthew Solomito, PhD', 'role': 'CONTACT', 'email': 'matthew.solomito@hhchealth.org', 'phone': '203-525-7659'}], 'overallOfficials': [{'name': 'Farhan Karim, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hartford Hospital; Hartford Healthcare Bone & Joint Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Farhan Karim', 'class': 'OTHER'}, 'collaborators': [{'name': 'DePuy Synthes', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Spine Surgeon', 'investigatorFullName': 'Farhan Karim', 'investigatorAffiliation': 'Hartford Hospital'}}}}