Lumbar Degenerative DiseaseNCT06904898
CONDUIT vs. PEEK Cages
A study testing Cougar LS/Syncage ALIF or CONDUIT LLIF/ALIF cage in people with Lumbar Degenerative Disease, run by University of Pennsylvania at 1 site in United States.
Trial summary
In this study, the Principal Investigator aim to compare the clinical and radiographic outcomes of patients with degenerative lumbar disease undergoing direct lateral interbody fusion (DLIF) using two different types of lateral interbody cages: PEEK cages combined with rhBMP-2 versus CONDUIT cages. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Degenerative Disease
- What is being tested?
- Cougar LS/Syncage ALIF or CONDUIT LLIF/ALIF cage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2021to 31 Jul 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • Patients with one to two consecutive level lumbar degenerative disease from L2to S1, including Grade 1 (<25%) Spondylolisthesis
- Patients undergoing direct lateral interbody fusion (transpsoas or anterior-to-psoas approach) for lumbar disease
- Skeletally mature patients, aged 18 and older
- Patients able to fully comply with the clinical protocol and adhere to the follow-up schedule and protocol requirements
- Patients able to understand and sign the study-specific, IRB approved informed consent form
Who cannot join
- • Spondylolisthesis greater than Grade 1
- Traumatic lumbar disease
- Spinal Deformity
- Coronal Cobb angle greater than 40 degrees
- Severe sagittal imbalance
- Existing fusion construct longer than 2 consecutive levels
Show all 13Show fewer
- Active infection - systemic or local
- Tumor diagnosis
- Untreated osteoporosis, defined as T Spine < -2.5 on DEXA scan
- Active smoking habit
- Current incarceration
- Pregnancy
- Involvement in an active spinal litigation
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: CONDUIT vs. PEEK Cages in Patients Undergoing Direct Lateral Interbody Fusion (DLIF): A Randomized, Prospective Trial
In this study, the Principal Investigator aim to compare the clinical and radiographic outcomes of patients with degenerative lumbar disease undergoing direct lateral interbody fusion (DLIF) using two different types of lateral interbody cages: PEEK cages combined with rhBMP-2 versus CONDUIT cages. This will be a randomized, prospective, open-label clinical trial. By examining these two groups, the PI hope to determine whether PEEK cages with rhBMP-2 and CONDUIT cages are equally effective for DLIF procedures. The findings from this study will help us optimize the surgical approach for future patients undergoing DLIF.
Read the detailed description
Direct lateral interbody fusion (DLIF) is a powerful surgical tool in a spine surgeon's armamentarium to address lumbar spine pathology minimally invasively. It has been widely adopted amongst spine surgeons to gain access to the lumbar disc through a small incision on a patient's flank. Through a retroperitoneal approach, the surgeon can perform discectomy, prep end plates, and insert an interbody cage with a much longer (lateral-medial) and wider (anterior-posterior) footprint than posterior lumbar interbody fusion (PLIF). Using either transpsoas or anterior-to-psoas (ATP) technique, the surgeons are now able to address lumbar spine pathologies affecting L2 to S1 minimally invasively. Both approaches are acceptable and widely adopted amongst spine surgeons. There are many commercially available FDA-approved DLIF cages in market for spine surgeons to use. The cages made of polyetheretherketone (PEEK) and titanium are most commonly used. Many surgeons who use PEEK cages in DLIF supplement the construct with recombinant human bone morphogenic protein-2 (rhBMP-2) to achieve fusion. PEEK has an inert and hydrophobic property which does not induce osteogenesis. In-vitro studies demonstrate absence of bone formation through PEEK. By adding rhBMP-2, it may induce robust osteoinduction around PEEK, achieving fusion across disk space over time. On the other hand, porous titanium has all three properties: osteoconductivity, osteoinductivity, and osseointegration. This may create a more favorable environment for fusion, which obviates the need for rhBMP-2 supplementation. Both types of cages are approved for the study's indications and are routinely used in DLIF at Penn. The surgical staff is qualified to implant both devices.
Aside from the type of cage used, subjects' DLIF procedures will not be altered for the purposes of the study. There are no known differences in the risks and benefits of the two cages being studied. Cage choice in routine care is based on each individual surgeon's standard-of-care preference. As such, there is a possibility of the patient getting either of these cages placed, should they choose to not participate in the study.
- Conditions
- Lumbar Degenerative Disease
- Being tested
- Cougar LS/Syncage ALIF or CONDUIT LLIF/ALIF cage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cougar LS/Syncage ALIF or CONDUIT LLIF/ALIF cageDevice
Comparison between cages to determine the effectiveness and cost related to the study procedures.
| Study group | Role | What they receive |
|---|---|---|
| Conduit | Other | Patients undergoing DLIf (transposons or anterior-to-psoas approach) will be randomized to PEEK cages + rhBMP-2 vs. CONDUIT cages to compare the clinical outcomes and determine the associated cost. Receives: Device: Cougar LS/Syncage ALIF or CONDUIT LLIF/ALIF cage |
| PEEK + rh-BMP-2 cage | Other | Patients undergoing DLIf (transposons or anterior-to-psoas approach) will be randomized to PEEK cages + rhBMP-2 vs. CONDUIT cages to compare the clinical outcomes and determine the associated cost. Receives: Device: Cougar LS/Syncage ALIF or CONDUIT LLIF/ALIF cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes
Difference in fusion rates for patients who get the PEEK + rh-BMP-2 cage and those who get the CONDUIT cage.
Measured: 24 months
ODI scores
The ODI is comprised of ten items with associated statements for the patient to select which reflect the patient's ability to manage their everyday life while dealing with their pain. Each of the ten items in the ODI has six statements from which patients are requested to select one. This allows scoring from 0-5 for each item. A maximum score of 50 is possible. The score obtained by individual patients can be multiplied by 2, and this will provide a percentage score
Measured: 24 months
Secondary outcomes (1)
Cost
Costs associated with the PEEK + rh-BMP-2 and CONDUIT cages will be assessed.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start13 Mar 2021
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904898
- Sponsor's protocol ID
- 844964
- Status last verified
- Sep 2026
- First submitted
- 7 Mar 2025
- Last updated
- 24 Sep 2026
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONDUIT vs. PEEK Cages in Patients Undergoing Direct Lateral Interbody Fusion (DLIF): A Randomized, Prospective Trial
- ClinicalTrials.gov ID
- NCT06904898
- Acronym / sponsor ID
- 844964
- Conditions
- Lumbar Degenerative Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 13 Mar 2021 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 1 Apr 2025 (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.
In this study, the Principal Investigator aim to compare the clinical and radiographic outcomes of patients with degenerative lumbar disease undergoing direct lateral interbody fusion (DLIF) using two different types of lateral interbody cages: PEEK cages combined with rhBMP-2 versus CONDUIT cages. This will be a randomized, prospective, open-label clinical trial. By examining these two groups, the PI hope to determine whether PEEK cages with rhBMP-2 and CONDUIT cages are equally effective for DLIF procedures. The findings from this study will help us optimize the surgical approach for future patients undergoing DLIF.
Detailed description
Direct lateral interbody fusion (DLIF) is a powerful surgical tool in a spine surgeon's armamentarium to address lumbar spine pathology minimally invasively. It has been widely adopted amongst spine surgeons to gain access to the lumbar disc through a small incision on a patient's flank. Through a retroperitoneal approach, the surgeon can perform discectomy, prep end plates, and insert an interbody cage with a much longer (lateral-medial) and wider (anterior-posterior) footprint than posterior lumbar interbody fusion (PLIF). Using either transpsoas or anterior-to-psoas (ATP) technique, the surgeons are now able to address lumbar spine pathologies affecting L2 to S1 minimally invasively. Both approaches are acceptable and widely adopted amongst spine surgeons. There are many commercially available FDA-approved DLIF cages in market for spine surgeons to use. The cages made of polyetheretherketone (PEEK) and titanium are most commonly used. Many surgeons who use PEEK cages in DLIF supplement the construct with recombinant human bone morphogenic protein-2 (rhBMP-2) to achieve fusion. PEEK has an inert and hydrophobic property which does not induce osteogenesis. In-vitro studies demonstrate absence of bone formation through PEEK. By adding rhBMP-2, it may induce robust osteoinduction around PEEK, achieving fusion across disk space over time. On the other hand, porous titanium has all three properties: osteoconductivity, osteoinductivity, and osseointegration. This may create a more favorable environment for fusion, which obviates the need for rhBMP-2 supplementation. Both types of cages are approved for the study's indications and are routinely used in DLIF at Penn. The surgical staff is qualified to implant both devices.
Aside from the type of cage used, subjects' DLIF procedures will not be altered for the purposes of the study. There are no known differences in the risks and benefits of the two cages being studied. Cage choice in routine care is based on each individual surgeon's standard-of-care preference. As such, there is a possibility of the patient getting either of these cages placed, should they choose to not participate in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conduit | Other | Device: Cougar LS/Syncage ALIF or CONDUIT LLIF/ALIF cagePatients undergoing DLIf (transposons or anterior-to-psoas approach) will be randomized to PEEK cages + rhBMP-2 vs. CONDUIT cages to compare the clinical outcomes and determine the associated cost. |
| PEEK + rh-BMP-2 cage | Other | Device: Cougar LS/Syncage ALIF or CONDUIT LLIF/ALIF cagePatients undergoing DLIf (transposons or anterior-to-psoas approach) will be randomized to PEEK cages + rhBMP-2 vs. CONDUIT cages to compare the clinical outcomes and determine the associated cost. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients with one to two consecutive level lumbar degenerative disease from L2to S1, including Grade 1 (<25%) Spondylolisthesis
Key exclusion criteria (13 listed)
- • Spondylolisthesis greater than Grade 1
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 |
|---|---|---|
| Cougar LS/Syncage ALIF or CONDUIT LLIF/ALIF cageComparison between cages to determine the effectiveness and cost related to the study procedures. | Device | Conduit, PEEK + rh-BMP-2 cage |
Primary outcome
Clinical outcomes
Time frame: 24 months
Difference in fusion rates for patients who get the PEEK + rh-BMP-2 cage and those who get the CONDUIT cage.
ODI scores
Time frame: 24 months
The ODI is comprised of ten items with associated statements for the patient to select which reflect the patient's ability to manage their everyday life while dealing with their pain. Each of the ten items in the ODI has six statements from which patients are requested to select one. This allows scoring from 0-5 for each item. A maximum score of 50 is possible. The score obtained by individual patients can be multiplied by 2, and this will provide a percentage score
1 secondary outcome
Cost
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cougar LS/Syncage ALIF or CONDUIT LLIF/ALIF cage in people with Lumbar Degenerative Disease, run by University of Pennsylvania 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 13 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: finished, as of the sponsor's last update on 24 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical outcomes (time frame: 24 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 24 Sep 2026.