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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 September 2021 |
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Main ID: |
NCT05023733 |
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Date of registration:
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16/08/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical and Radiographic Outcomes of TLIF w/3D Printed Cellular Implant
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Scientific title:
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Clinical and Radiographic Outcomes of Transforaminal Lumbar Interbody Fusion (TLIF) With a Novel 3D Printed Cellular Titanium Implant |
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Date of first enrolment:
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October 1, 2021 |
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Target sample size:
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150 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT05023733 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Farhan Karim, DO |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hartford Hospital; Hartford Healthcare Bone & Joint Institute |
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Name:
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Bethany Samperi |
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Address:
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Telephone:
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860-972-5978 |
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Email:
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bethany.samperi@hhchealth.org |
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Affiliation:
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Name:
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Bethany Samperi |
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Address:
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Telephone:
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860-972-5978 |
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Email:
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bethany.samperi@hhchealth.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Skeletally mature adults ages 35 - 80 years of age, inclusive
- Diagnosis of lumbar degenerative disc disease with or without neurologic deficit and
associated central and/or unilateral/bilateral foraminal stenosis
- Subject undergoing one or two level transforaminal lumbar interbody fusion
- Able to read and understand all documents used in this study , including the informed
consent and patient-reported outcome questionnaires
Exclusion Criteria:
- Patients over 80 years of age
- Patients under 35 years of age
- Current smokers
- BMI>42
- Subject has spondylolisthesis > 2
- Subjects with multilevel >2 levels of symptomatic disease
- Subjects with significant spinal deformity
- Subject is pregnant, plans to become pregnant or is breast feeding
Age minimum:
35 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lumbar Spondylolisthesis
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Lumbar Spinal Stenosis
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Degenerative Disc Disease
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Foraminal Stenosis
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Intervention(s)
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Device: CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®
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Primary Outcome(s)
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Radiographic Fusion
[Time Frame: 18 months]
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Radiographic Fusion
[Time Frame: 24 months]
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Secondary Outcome(s)
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Intervention Rates
[Time Frame: up to 24 months]
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Adverse Events
[Time Frame: up to 24 months]
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Back and Leg Visual Analog Scale (VAS)
[Time Frame: 12 months]
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Back and Leg Visual Analog Scale (VAS)
[Time Frame: 6 months]
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Back and Leg Visual Analog Scale
[Time Frame: 18 months]
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Oswestry Disability Index (ODI)
[Time Frame: 12 months]
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Oswestry Disability Index (ODI)
[Time Frame: 18 months]
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Oswestry Disability Index (ODI)
[Time Frame: 6 months]
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Secondary ID(s)
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HHC-2020-0243
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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