Can a nanotube surface help spinal bones fuse faster?

NCT ID NCT07777718

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial compares two FDA-approved cages used in lower back fusion surgery to see if one helps the bones fuse together better than the other. Adults undergoing a 1- or 2-level lumbar fusion for degenerative disc disease will be randomly assigned to receive either a cage with a nanotube surface or one with a titanium coating. Follow-up visits include imaging and questionnaires to assess bone fusion, pain, physical function, and overall health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Adaptix nanoPEEK cage (a spinal fusion device with a nanotube surface) versus Capstone PTC cage (a spinal fusion device with a titanium coating)
What this could lead to
If the nanotube cage proves superior, it could lead to better bone fusion rates and improved outcomes for people undergoing lumbar fusion surgery.
What could go wrong
This is a single-center trial with 108 participants, so results may not apply broadly. The difference between cages may be small, and surgery risks like infection or implant failure remain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 108 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. 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). * 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Kentucky

    Lexington, Kentucky, 40506, United States

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