ClinicalTrials.gg
Not yet recruitingNCT07777718Updated Oct 16, 2026

Lumbar Fusion With Nanotube Versus Titanium Cage

An interventional study of Adaptix nanoPEEK Cage and Capstone PTC Cage in Degenerative Disc Disease and Lumbar Fusion, sponsored by Francis Farhadi. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Francis Farhadi · Not applicable, Interventional, and Treatment

Updated Oct 16, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Degenerative Disc Disease
  • Lumbar Fusion
03

In context

Intervertebral Disc Degeneration

462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.

This study's planned enrollment of 108 is above the median of 60 across 256 interventional studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

Francis Farhadi is the lead sponsor of 9 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
  • (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.
  • Active or history of spinal malignancy.
  • Known diabetes mellitus with preoperative =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 , 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 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    Adaptix nanoPEEK Cage

    Participants will receive the Adaptix nanoPEEK Cage during lumbar fusion surgery.

    Device: Adaptix nanoPEEK Cage

  • Active comparator
    Capstone PTC Cage

    Participants will receive the Capstone PTC Cage during lumbar fusion surgery.

    Device: Capstone PTC Cage

Interventions

  • DeviceAdaptix nanoPEEK Cage

    FDA- approved interbody cage used during lumbar fusion surgery.

  • DeviceCapstone PTC Cage

    FDA- approved interbody cage used during lumbar fusion surgery.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 Months After Surgery

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Apr 2028, 18 months later.

Of 40 non-industry interventional studies with no phase under Intervertebral Disc Degeneration, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 63. This study's planned 18 months is below that.

Counting every sponsor, half of 85 studies reached it within 50 months; a quarter within 27 and three quarters within 72.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 16, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 20, 2026
StartEst.
Oct 2026was Sep 2026
Primary completionEst.
Apr 30, 2028
CompletionEst.
Apr 30, 2028
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 2026→Oct 2026
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Start date Sep 2026→Oct 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07777718
Lead sponsor
Francis Farhadi
Responsible party
Francis Farhadi (Associate Professor, University of Kentucky) — Sponsor-investigator
First posted
Aug 20, 2026
Start date
Oct 2026 (estimated)
Primary completion
Apr 30, 2028 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Oct 16, 2026

Study contacts

Francis Farhadi, MD, PhD
Contact
Francis.Farhadi@uky.edu
859-562-0247

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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