Can a nanotube surface help spinal bones fuse faster?
NCT ID NCT07777718
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
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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
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About 108 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Kentucky
Lexington, Kentucky, 40506, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 5,000+ patients enrolled in spine device safety study