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
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