Spinal FusionNCT05583864
Lumbar Fusion With Porous Versus Non-Porous Cages
A study testing CONDUIT Porous Titanium Spinal Cage and PROTI 360 Titanium-Coated PEEK Spinal Cage in people with Spinal Fusion and Lumbar Fusion, run by Francis Farhadi at 1 site in United States.
Trial summary
The objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions: 1. Porous titanium cages 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Fusion, Lumbar Fusion, Arthrodesis
- What is being tested?
- CONDUIT Porous Titanium Spinal Cage and PROTI 360 Titanium-Coated PEEK Spinal Cage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be considered for inclusion if:
- They are scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the DePuy Synthes CONDUIT™ porous titanium cage or the DePuy Synthes PROTI 360º™ non-porous titanium-coated PEEK cage in conjunction with local autograft bone, and supplementation with a pedicle screw system.
- They are over the age of 18 years old.
- They have been unresponsive to conservative care for a minimum of 6 months.
- They are in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
Who cannot join
- Certain comorbidities and medical statuses may render patients ineligible for surgery, or put them at an increased risk for complications or injury by participating in the study. Therefore, patients will be excluded from enrollment if:
- They have had previous lumbar arthrodesis surgery.
- They require additional bone grafting materials other than local autograft bone.
- There is inadequate tissue coverage over the operative site.
- There is an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
- Subject has a condition requiring medications that may interfere with bone or soft tissue healing(i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
Show all 15Show fewer
- Subject has an active local or systemic infection.
- Subject has a metal sensitivity/foreign body sensitivity (cages will be implanted).
- Subject is morbidly obese, defined as a body mass index (BMI) greater than 40.
- Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
- Subject is currently involved in another investigational drug or device study that could confound study data.
- There is a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
- Subjects who are pregnant or plan to become pregnant in the next 12 months or who are lactating. This restriction is due to the inherent risk radiography presents to an embryo or fetus and is considered standard of care.
- Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain. Participation may effect the assessments made by case workers and legal teams.
- Subject is a prisoner.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lumbar Fusion With Porous Titanium Versus Non-Porous Titanium-Coated PEEK Interbody Cages - A Randomized Controlled Trial
The objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions:
- Porous titanium cages
- Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages.
Read the detailed description
This single-center randomized controlled trial will prospectively evaluate the safety and efficacy of porous titanium cages supplemented with a pedicle screw system as compared to titanium-coated PEEK cages currently used in routine fashion for lumbar interbody fusion procedures.
These cages are FDA approved and the study is designed to compare the outcomes of subjects receiving either implant. This study will capture clinical and radiographic outcomes on patients up to 2 years post-operatively. Both cages will be used in conjunction with milled local autograft bone generated as part of the spinal fusion procedure (no iliac crest autograft will be utilized).
This study will enroll a maximum of 108 subjects (approximately n = 54 per group), with subjects followed for a minimum of 12 months post-surgery. A total cage sample size of 108 cages (n = 54 cages per group) was calculated with a power of 80% (alpha =0.05) and based on the assumption that 55% of cages in the titanium-coated PEEK group would achieve a solid fusion by 6 months, as compared to 80% in the porous titanium group. Up to two cages may be placed in a single subject. Therefore, it is possible that the maximum number of human subjects would be 54 if all are multi-level procedures. Since there are always mixtures of single and multi-level procedures, the actual number of subjects will be closer to 80, with a maximum ceiling of 108.
These assumptions are based on prior imaging findings in patients undergoing TLIF procedures using these cages. An interim analysis is planned once, at minimum, half of the cage accrual is met. In the case early findings show a statistical difference in the primary outcome between the two cages, enrollment will be allowed to cease as investigators are unlikely to maintain clinical equipoise to continue randomizing patients. Conversely, if the interim analysis suggests that statistical significance is unlikely, the investigators will be allowed to choose to close the trial early for futility.
Randomization will occur in 4 and 6 subject blocks to ensure comparability and enhance blinding for this sample size. Subjects will be further stratified for smoking due to the significant risk it places on successful fusion outcomes.
- Conditions
- Spinal Fusion, Lumbar Fusion, Arthrodesis, Spondylolisthesis, Pseudarthrosis
- Being tested
- CONDUIT Porous Titanium Spinal Cage, PROTI 360 Titanium-Coated PEEK Spinal Cage
- Keywords
- Spinal Cage, PEEK, Pseudarthrosis, Spondylolisthesis, Titanium, Fusion, Transforaminal, Interbody, Posterolateral, CONDUIT, PROTI 360, TLIF
- Medical subject headings
- Ankylosis, Spondylolisthesis, Pseudarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONDUIT Porous Titanium Spinal CageDevice
Also called DePuy Synthes CONDUIT™
Already included in arm/group descriptions.
PROTI 360 Titanium-Coated PEEK Spinal CageDevice
Also called DePuy Synthes PROTI 360º™
Already included in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| CONDUIT Porous Titanium Spinal Cage | Active comparator | Solid titanium spinal cage, infused with microscopic, porous canals to allow for adhesion and proliferation of bone graft factors contributing to spinal ossification, and ultimately, spinal fusion between vertebrae demonstrating instability. Receives: Device: CONDUIT Porous Titanium Spinal Cage |
| PROTI 360 Titanium-Coated PEEK Spinal Cage | Active comparator | Spinal cage composed primarily of a medical-grade polymer: poly-ether-ether-ketone (PEEK), with a titanium coating that is etched, but lacking porous features. These design features also attempt to stimulate spinal vertebrae fusion through bone-graft ossification and enhance vertebral stability. Receives: Device: PROTI 360 Titanium-Coated PEEK Spinal Cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brantigan-Steffee-Frasier (BSF) Fusion Scale
Graded radiographic evaluation of ossification and/or pseudarthrosis between vertebrae. The evaluation applies a three-level scale of fusion success:
BSF-1: Radiographical pseudarthrosis BSF-2: Radiographical locked pseudarthrosis BSF-3: Radiographical fusion
Radiographic Success: Radiographic success is defined by radiographical fusion (BSF-3) presenting bone bridges within at least half of the fusion area with at least the density originally achieved at surgery.
Radiographic Failure: Radiographic failure is defined by radiographical pseudarthrosis (BSF-1 or -2)
Measured: Six months following procedure
Secondary outcomes (3)
Oswestry Disability Index (ODIv2.1a)
Subject self-assessment survey pertaining to quality-of-life and pain measures. Scale ranges from 0-100%. The higher the percentage, the lower the quality of life and the greater the pain.
Measured: Preoperative, three, six, twelve, and twenty-four month follow-ups.
Neurological Pain Scale for Back and Legs
Subject self-assessment survey pertaining to pain presence in legs and back. The scale runs from 0-10, with 0 indicating no pain and 10 the worst pain possible.
Measured: Preoperative, three, six, twelve, and twenty-four month follow-ups.
PROMIS-10 Global
Patient reported survey to rate quality-of-life and pain experience throughout life of study. Initially gives a raw score for both physical and mental well-being between 4 and 20, which is converted into a T-score between 16.2 and 67.7. The T-score is directly correlated with what is being evaluated. In other words, the higher the T-score, the higher the quality of life and the lower the pain.
Measured: Preoperative, three, six, twelve, and twenty-four month follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Nov 2022
- Primary completion10 Jun 2026
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two types of spinal cages will be evaluated against one another for patient outcomes. It is possible that a single patient may receive both cages, but outcomes will be radiographically assessed individually by cage.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francis Farhadi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francis Farhadi, University of Kentucky
- Investigators
- Francis Farhadi, MD, PhD, Principal investigator, University of KentuckyCraig van Horne, MD, PhD, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583864
- Sponsor's protocol ID
- 77018
- Status last verified
- Jul 2026
- First submitted
- 13 Oct 2022
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Fusion With Porous Titanium Versus Non-Porous Titanium-Coated PEEK Interbody Cages - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05583864
- Acronym / sponsor ID
- 77018
- Conditions
- Spinal Fusion, Lumbar Fusion, Arthrodesis, Spondylolisthesis, Pseudarthrosis
- Keywords
- Spinal Cage, PEEK, Pseudarthrosis, Spondylolisthesis, Titanium, Fusion, Transforaminal, Interbody
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Francis FarhadiUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Oct 2022 (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.
The objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions:
- Porous titanium cages
- Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages.
Detailed description
This single-center randomized controlled trial will prospectively evaluate the safety and efficacy of porous titanium cages supplemented with a pedicle screw system as compared to titanium-coated PEEK cages currently used in routine fashion for lumbar interbody fusion procedures.
These cages are FDA approved and the study is designed to compare the outcomes of subjects receiving either implant. This study will capture clinical and radiographic outcomes on patients up to 2 years post-operatively. Both cages will be used in conjunction with milled local autograft bone generated as part of the spinal fusion procedure (no iliac crest autograft will be utilized).
This study will enroll a maximum of 108 subjects (approximately n = 54 per group), with subjects followed for a minimum of 12 months post-surgery. A total cage sample size of 108 cages (n = 54 cages per group) was calculated with a power of 80% (alpha =0.05) and based on the assumption that 55% of cages in the titanium-coated PEEK group would achieve a solid fusion by 6 months, as compared to 80% in the porous titanium group. Up to two cages may be placed in a single subject. Therefore, it is possible that the maximum number of human subjects would be 54 if all are multi-level procedures. Since there are always mixtures of single and multi-level procedures, the actual number of subjects will be closer to 80, with a maximum ceiling of 108.
These assumptions are based on prior imaging findings in patients undergoing TLIF procedures using these cages. An interim analysis is planned once, at minimum, half of the cage accrual is met. In the case early findings show a statistical difference in the primary outcome between the two cages, enrollment will be allowed to cease as investigators are unlikely to maintain clinical equipoise to continue randomizing patients. Conversely, if the interim analysis suggests that statistical significance is unlikely, the investigators will be allowed to choose to close the trial early for futility.
Randomization will occur in 4 and 6 subject blocks to ensure comparability and enhance blinding for this sample size. Subjects will be further stratified for smoking due to the significant risk it places on successful fusion outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Two types of spinal cages will be evaluated against one another for patient outcomes. It is possible that a single patient may receive both cages, but outcomes will be radiographically assessed individually by cage.
| Arm | Type | Receives |
|---|---|---|
| CONDUIT Porous Titanium Spinal Cage | Active comparator | Device: CONDUIT Porous Titanium Spinal CageSolid titanium spinal cage, infused with microscopic, porous canals to allow for adhesion and proliferation of bone graft factors contributing to spinal ossification, and ultimately, spinal fusion between vertebrae demonstrating instability. |
| PROTI 360 Titanium-Coated PEEK Spinal Cage | Active comparator | Device: PROTI 360 Titanium-Coated PEEK Spinal CageSpinal cage composed primarily of a medical-grade polymer: poly-ether-ether-ketone (PEEK), with a titanium coating that is etched, but lacking porous features. These design features also attempt to stimulate spinal vertebrae fusion through bone-graft ossification and enhance vertebral stability. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- They are scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the DePuy Synthes CONDUIT™ porous titanium cage or the DePuy Synthes PROTI 360º™ non-porous titanium-coated PEEK cage in conjunction with local autograft bone, and supplementation with a pedicle screw system.
- They are over the age of 18 years old.
- They have been unresponsive to conservative care for a minimum of 6 months.
- They are in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
Key exclusion criteria (15 listed)
- Certain comorbidities and medical statuses may render patients ineligible for surgery, or put them at an increased risk for complications or injury by participating in the study. Therefore, patients will be excluded from enrollment if:
- They have had previous lumbar arthrodesis surgery.
- They require additional bone grafting materials other than local autograft bone.
- There is inadequate tissue coverage over the operative site.
- There is an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
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 Porous Titanium Spinal CageAlso: DePuy Synthes CONDUIT™Already included in arm/group descriptions. | Device | CONDUIT Porous Titanium Spinal Cage |
| PROTI 360 Titanium-Coated PEEK Spinal CageAlso: DePuy Synthes PROTI 360º™Already included in arm/group descriptions. | Device | PROTI 360 Titanium-Coated PEEK Spinal Cage |
Primary outcome
Brantigan-Steffee-Frasier (BSF) Fusion Scale
Time frame: Six months following procedure
Graded radiographic evaluation of ossification and/or pseudarthrosis between vertebrae. The evaluation applies a three-level scale of fusion success: BSF-1: Radiographical pseudarthrosis BSF-2: Radiographical locked pseudarthrosis BSF-3: Radiographical fusion Radiographic Success: Radiographic success is defined by radiographical fusion (BSF-3) presenting bone bridges within at least half of the fusion area with at least the density originally achieved at surgery. Radiographic Failure: Radiographic failure is defined by radiographical pseudarthrosis (BSF-1 or -2)
3 secondary outcomes
Oswestry Disability Index (ODIv2.1a)
Time frame: Preoperative, three, six, twelve, and twenty-four month follow-ups.
Neurological Pain Scale for Back and Legs
Time frame: Preoperative, three, six, twelve, and twenty-four month follow-ups.
PROMIS-10 Global
Time frame: Preoperative, three, six, twelve, and twenty-four month follow-ups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Francis Farhadi, MD, PhD principal investigator
University of Kentucky
Craig van Horne, MD, PhD study director
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONDUIT Porous Titanium Spinal Cage and PROTI 360 Titanium-Coated PEEK Spinal Cage in people with Spinal Fusion and Lumbar Fusion, run by Francis Farhadi 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 5 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brantigan-Steffee-Frasier (BSF) Fusion Scale (time frame: Six months following procedure). 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 6 Jul 2026.