Degenerative Disc DiseaseNCT07777718
Lumbar Fusion With Nanotube Versus Titanium Cage
A study testing Adaptix nanoPEEK Cage and Capstone PTC Cage in people with Degenerative Disc Disease and Lumbar Fusion, run by Francis Farhadi at 1 site in United States.
Trial summary
This study is comparing two FDA-approved cages used during lower back surgery. The study will look at whether one cage helps the bones in the back fuse together better than the other. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Disc Disease, Lumbar Fusion
- What is being tested?
- Adaptix nanoPEEK Cage and Capstone PTC 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
- Oct 2026to 30 Apr 2028
- 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
- Subject is scheduled to undergo 1- or 2-level TLIF with the principal investigator.
- Subject has failed nonoperative management for a minimum of 3 months prior to enrollment.
- Diagnosis is degenerative disc disease (DDD), defined as discogenic back pain with disc degeneration confirmed by history and radiographic studies, at 1 or 2 contiguous spinal levels from L2 to S1. Subjects may have up to grade 1-2 spondylolisthesis or retrolisthesis at the index level(s).
- Subject is able to provide written informed consent.
- Subject is, in the investigator's opinion, psychosocially, mentally, and physically able to comply with the protocol, required follow-up visits, and completion of required study forms.
Who cannot join
- Prior lumbar arthrodesis surgery at any level.
- Diagnosis of osteoporosis (T-score = -2.5) or severe osteopenia (T-score = -2.0 with fragility fracture history).
- Body mass index (BMI) greater than 40 kg/m².
- Requirement for additional bone grafting materials beyond milled local autograft bone (e.g., rhBMP-2, iliac crest autograft, allograft structural spacers).
- Active local or systemic infection.
- Known metal sensitivity or foreign body reaction to titanium or PEEK.
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- Active malignancy or history of spinal malignancy.
- Known diabetes mellitus with preoperative HbA1c =8%, confirmed within 90 days of the planned surgery date. Diabetic patients with HbA1c <8% are eligible following standard preoperative medical optimization.
- Condition requiring medications known to interfere with bone healing (chronic oral or parenteral glucocorticoids, immunosuppressives, bisphosphonates initiated within 3 months of surgery, methotrexate, or similar agents).
- Inadequate tissue coverage over the operative site or open wound at the operative area.
- Pregnancy or planned pregnancy within the next 12 months, or currently lactating.
- Current involvement in litigation or receipt of Worker's Compensation related to back or leg pain.
- Current enrollment in another investigational drug or device study that could confound study data.
- History (present or past) of substance abuse that, in the investigator's opinion, would interfere with protocol adherence or follow-up completion.
- Any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude safe participation in the study.
- Subject is a prisoner.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Kentucky
Lexington, Kentucky, 40506
Francis Farhadi, MD, PhD, 859-562-0247, Francis.Farhadi@uky.edu
About this study
Official title: Nanotube Surface Architecture Versus Simple Titanium Coating on PEEK Interbody Cages in Adults Undergoing 1- and 2-Level Transforaminal Lumbar Interbody Fusion: A Randomized Controlled Superiority Trial
This study is comparing two FDA-approved cages used during lower back surgery. The study will look at whether one cage helps the bones in the back fuse together better than the other. Adults who are having a 1 or 2 level lumbar fusion surgery will be randomly assigned to receive either the Adaptix nanoPEEK cage or the Capstone PTC cage. Participants will have follow-up visits with imaging and questionnaires to evaluate bone fusion, back and leg pain, physical function, and overall health.
Read the detailed description
This study is a single-center, single-blind, randomized controlled superiority trial at the University of Kentucky. The study will enroll adults who are undergoing a 1 or 2 level transforaminal lumbar interbody fusion (TLIF) for degenerative disc disease.
Participants will be randomly assigned in a 1:1 ratio to receive either the Adaptix nanoPEEK cage or the Capstone PTC cage during their lumbar fusion surgery. Both cages are FDA-Approved and are used as part of the standard-of-care lumbar fusion surgery. The study is comparing the outcomes of the two cages to determine whether one results in better spinal fusion outcomes.
Participants will have follow-up visits after surgery. X-rays will be performed at follow-up visits and a CT scan will be performed at 6 months to evaluate the progress of spinal fusion and the condition of the device and graft. An independent radiologist will review the imaging. Participants will also complete questionnaires about disability, overall health, and back and leg pain. Follow-up may continue for up to 24 months after surgery.
- Conditions
- Degenerative Disc Disease, Lumbar Fusion
- Being tested
- Adaptix nanoPEEK Cage, Capstone PTC Cage
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptix nanoPEEK CageDevice
FDA- approved interbody cage used during lumbar fusion surgery.
Capstone PTC CageDevice
FDA- approved interbody cage used during lumbar fusion surgery.
| Study group | Role | What they receive |
|---|---|---|
| Adaptix nanoPEEK Cage | Experimental | Participants will receive the Adaptix nanoPEEK Cage during lumbar fusion surgery. Receives: Device: Adaptix nanoPEEK Cage |
| Capstone PTC Cage | Active comparator | Participants will receive the Capstone PTC Cage during lumbar fusion surgery. Receives: Device: Capstone PTC Cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Fusion
Radiographic fusion will be assessed using the Brantigan and Steffee classification as modified by Fraser (BSF Scale). Radiographic success is defined as BSF-3 fusion, with bone bridges present with at least half fusion area and at least the density originally achieved at surgery.
Measured: 6 Months After Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startOct 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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
- Participants will be randomly assigned in a 1:1 ratio to receive either the Adaptix nanoPEEK cage or the Capstone PTC cage during lumbar fusion surgery. Participants will remain in their assigned group throughout the study.
- Masking
- Single blind
- Who is masked
- Participant
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777718
- Sponsor's protocol ID
- 115495
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanotube Surface Architecture Versus Simple Titanium Coating on PEEK Interbody Cages in Adults Undergoing 1- and 2-Level Transforaminal Lumbar Interbody Fusion: A Randomized Controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT07777718
- Acronym / sponsor ID
- 115495
- Conditions
- Degenerative Disc Disease, Lumbar Fusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Francis FarhadiUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 20 Aug 2026 (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 comparing two FDA-approved cages used during lower back surgery. The study will look at whether one cage helps the bones in the back fuse together better than the other. Adults who are having a 1 or 2 level lumbar fusion surgery will be randomly assigned to receive either the Adaptix nanoPEEK cage or the Capstone PTC cage. Participants will have follow-up visits with imaging and questionnaires to evaluate bone fusion, back and leg pain, physical function, and overall health.
Detailed description
This study is a single-center, single-blind, randomized controlled superiority trial at the University of Kentucky. The study will enroll adults who are undergoing a 1 or 2 level transforaminal lumbar interbody fusion (TLIF) for degenerative disc disease.
Participants will be randomly assigned in a 1:1 ratio to receive either the Adaptix nanoPEEK cage or the Capstone PTC cage during their lumbar fusion surgery. Both cages are FDA-Approved and are used as part of the standard-of-care lumbar fusion surgery. The study is comparing the outcomes of the two cages to determine whether one results in better spinal fusion outcomes.
Participants will have follow-up visits after surgery. X-rays will be performed at follow-up visits and a CT scan will be performed at 6 months to evaluate the progress of spinal fusion and the condition of the device and graft. An independent radiologist will review the imaging. Participants will also complete questionnaires about disability, overall health, and back and leg pain. Follow-up may continue for up to 24 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either the Adaptix nanoPEEK cage or the Capstone PTC cage during lumbar fusion surgery. Participants will remain in their assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Adaptix nanoPEEK Cage | Experimental | Device: Adaptix nanoPEEK CageParticipants will receive the Adaptix nanoPEEK Cage during lumbar fusion surgery. |
| Capstone PTC Cage | Active comparator | Device: Capstone PTC CageParticipants will receive the Capstone PTC Cage during lumbar fusion surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is scheduled to undergo 1- or 2-level TLIF with the principal investigator.
- Subject has failed nonoperative management for a minimum of 3 months prior to enrollment.
- Diagnosis is degenerative disc disease (DDD), defined as discogenic back pain with disc degeneration confirmed by history and radiographic studies, at 1 or 2 contiguous spinal levels from L2 to S1. Subjects may have up to grade 1-2 spondylolisthesis or retrolisthesis at the index level(s).
- Subject is able to provide written informed consent.
- Subject is, in the investigator's opinion, psychosocially, mentally, and physically able to comply with the protocol, required follow-up visits, and completion of required study forms.
Key exclusion criteria (16 listed)
- Prior lumbar arthrodesis surgery at any level.
- Diagnosis of osteoporosis (T-score = -2.5) or severe osteopenia (T-score = -2.0 with fragility fracture history).
- Body mass index (BMI) greater than 40 kg/m².
- Requirement for additional bone grafting materials beyond milled local autograft bone (e.g., rhBMP-2, iliac crest autograft, allograft structural spacers).
- Active local or systemic infection.
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 |
|---|---|---|
| Adaptix nanoPEEK CageFDA- approved interbody cage used during lumbar fusion surgery. | Device | Adaptix nanoPEEK Cage |
| Capstone PTC CageFDA- approved interbody cage used during lumbar fusion surgery. | Device | Capstone PTC Cage |
Primary outcome
Radiographic Fusion
Time frame: 6 Months After Surgery
Radiographic fusion will be assessed using the Brantigan and Steffee classification as modified by Fraser (BSF Scale). Radiographic success is defined as BSF-3 fusion, with bone bridges present with at least half fusion area and at least the density originally achieved at surgery.
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 16 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptix nanoPEEK Cage and Capstone PTC Cage in people with Degenerative Disc Disease 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 16 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: opening soon, as of the sponsor's last update on 16 Oct 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?
Contact Francis Farhadi, MD, PhD (859-562-0247, Francis.Farhadi@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Fusion (time frame: 6 Months After Surgery). 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 16 Oct 2026.