Clinical trial NCT05023733: Clinical and Radiographic Outcomes of TLIF w/3D Printed Cellular Implant
Official title: Clinical and Radiographic Outcomes of Transforaminal Lumbar Interbody Fusion (TLIF) With a Novel 3D Printed Cellular Titanium Implant
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Foraminal Stenosis
Degenerative Disc Disease
Lumbar Spondylolisthesis
Lumbar Spinal Stenosis
Keywords: transforaminal
degenerative disc disease (DDD)
Lumbar Fusion
Interbody Fusion
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2021-08-27
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiographic Fusion
timeFrame: 18 months
measure: Radiographic Fusion
timeFrame: 24 months
Secondary outcomes:
measure: Back and Leg Visual Analog Scale (VAS)
timeFrame: 6 months
measure: Back and Leg Visual Analog Scale (VAS)
timeFrame: 12 months
measure: Back and Leg Visual Analog Scale
timeFrame: 18 months
measure: Oswestry Disability Index (ODI)
timeFrame: 6 months
measure: Oswestry Disability Index (ODI)
timeFrame: 12 months
measure: Oswestry Disability Index (ODI)
timeFrame: 18 months
measure: Adverse Events
timeFrame: up to 24 months
measure: Intervention Rates
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Healthcare Bone and Joint Institute
state: Connecticut
Study officials:
affiliation: Hartford Hospital; Hartford Healthcare Bone & Joint Institute
name: Farhan Karim, DO
role: PRINCIPAL_INVESTIGATOR
References: