Foraminal StenosisNCT05023733
Clinical and Radiographic Outcomes of TLIF w/3D Printed Cellular Implant
An observational study of Foraminal Stenosis and Degenerative Disc Disease, run by Farhan Karim at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Foraminal Stenosis, Degenerative Disc Disease, Lumbar Spondylolisthesis
- What is being tested?
- CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hartford Healthcare Bone and Joint Institute
Hartford, Connecticut, 06106
Bethany Samperi, 860-972-5978, bethany.samperi@hhchealth.org
Matthew Solomito, PhD, 203-525-7659, matthew.solomito@hhchealth.org
About this study
Official title: Clinical and Radiographic Outcomes of Transforaminal Lumbar Interbody Fusion (TLIF) With a Novel 3D Printed Cellular Titanium Implant
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.
Read the 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.
- Conditions
- Foraminal Stenosis, Degenerative Disc Disease, Lumbar Spondylolisthesis, Lumbar Spinal Stenosis
- Being tested
- CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®
- Keywords
- transforaminal, degenerative disc disease (DDD), Lumbar Fusion, Interbody Fusion
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®Device
Also called lumbar fusion
Patients undergoing 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1
| Study group | Role | What they receive |
|---|---|---|
| 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1 | 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. Receives: Device: CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Fusion
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
Measured: 18 months
Radiographic Fusion
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
Measured: 24 months
Secondary outcomes (8)
Back and Leg Visual Analog Scale (VAS)
Improvement in the VAS as measured by a minimum of a 20 point improvement
Measured: 6 months
Back and Leg Visual Analog Scale (VAS)
Improvement in the VAS as measured by a minimum of a 20 point improvement
Measured: 12 months
Back and Leg Visual Analog Scale
Improvement in the VAS as measured by a minimum of a 20 point improvement
Measured: 18 months
Oswestry Disability Index (ODI)
Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) >20%
Measured: 6 months
Oswestry Disability Index (ODI)
Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) >20%
Measured: 12 months
Oswestry Disability Index (ODI)
Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) >20%
Measured: 18 months
Adverse Events
Number of procedure and device related adverse events
Measured: up to 24 months
Intervention Rates
Rates of reoperation and/or revision procedures at index level(s)
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Oct 2021
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foraminal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farhan Karim
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- Responsible party
- Sponsor-investigator, Farhan Karim, Hartford Hospital
- Investigators
- Farhan Karim, DO, Principal investigator, Hartford Hospital; Hartford Healthcare Bone & Joint Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023733
- Sponsor's protocol ID
- HHC-2020-0243
- Status last verified
- Jan 2022
- First submitted
- 16 Aug 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Transforaminal Lumbar Interbody Fusion (TLIF) With a Novel 3D Printed Cellular Titanium Implant
- ClinicalTrials.gov ID
- NCT05023733
- Acronym / sponsor ID
- HHC-2020-0243
- Conditions
- Foraminal Stenosis, Degenerative Disc Disease, Lumbar Spondylolisthesis, Lumbar Spinal Stenosis
- Keywords
- transforaminal, degenerative disc disease (DDD), Lumbar Fusion, Interbody Fusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Farhan KarimUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1 | – | Device: CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®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. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Patients over 80 years of age
- Patients under 35 years of age
- Current smokers
- BMI>42
- Subject has spondylolisthesis > 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®Also: lumbar fusionPatients undergoing 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1 | Device | 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1 |
Primary outcome
Radiographic Fusion
Time frame: 18 months
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
Radiographic Fusion
Time frame: 24 months
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
8 secondary outcomes
Back and Leg Visual Analog Scale (VAS)
Time frame: 6 months
Back and Leg Visual Analog Scale (VAS)
Time frame: 12 months
Back and Leg Visual Analog Scale
Time frame: 18 months
Oswestry Disability Index (ODI)
Time frame: 6 months
Oswestry Disability Index (ODI)
Time frame: 12 months
Oswestry Disability Index (ODI)
Time frame: 18 months
Adverse Events
Time frame: up to 24 months
Intervention Rates
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
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Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Enrolling by invitation
Prospective Evaluation of Upright Versus Supine CT Myelography of the Lumbar Spine
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The Selective Intraperineural Nerve Root Block Study
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Active, not recruitingObservational study
Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farhan Karim, DO principal investigator
Hartford Hospital; Hartford Healthcare Bone & Joint Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foraminal Stenosis and Degenerative Disc Disease, run by Farhan Karim at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bethany Samperi (860-972-5978, bethany.samperi@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Fusion (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.