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New titanium cage could improve neck surgery outcomes

NCT ID NCT04214535

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new titanium cage used in spinal fusion surgery for people with degenerative disc disease in the neck. Fifty participants will receive the device and be followed for up to 24 months to see if the bones fuse properly and if pain and function improve. It is a small pilot study, so results are preliminary.

What this could mean

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

Active substance
Tritanium C Anterior Cervical Cage (a medical device used in spinal fusion surgery)
What this could lead to
If successful, this device could improve spinal fusion rates and reduce pain for people with degenerative disc disease.
What could go wrong
This is a small, early pilot study with no comparison group, so results may not apply broadly. Surgery risks include infection, nerve damage, or failure of the bone to fuse.

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 50 people

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

Started

May 2021

Expected to finish

Mar 2027

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 years and older

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: 1. Patients undergoing a one or two (contiguous) level primary ACDF between C2-T1 2. Able to provide consent 3. ≥ 18 years of age and skeletally mature 4. Diagnosis of symptomatic degenerative disc disease, including; myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, spondylosis, osteophyte complexes, and foraminal stenosis 5. Neck pain and/or radicular symptoms with a baseline Visual Analog Scale score of ≥ 4 (0-10cm scale) for neck or arm pain 6. Baseline Neck Disability score ≥ 20 7. Had at least 6-weeks of conservative non-operative treatment and/or presents with increasing signs and symptoms of cervical myelopathy or radiculopathy that may require immediate intervention - Exclusion Criteria: 1\. Any prior history of cervical fusion 2. Requires cervical fusion of more than two levels or not contiguous levels 3. Acute cervical spine trauma requiring immediate intervention 4. BMI \> 40 5. Active systemic bacterial or fungal infection or infection at the operative site 6. History of vertebral fracture or osteoporotic fracture 7. Current treatment with chemotherapy, radiation, immunosuppression or chronic steroid therapy 8. History of osteoporosis, osteopenia, or osteomalacia that would contraindicate spinal surgery 9. Psychological or physical condition in the opinion of the investigator that would interfere with completing study participation including completion of patient reported outcomes 10. History of neurological condition in the opinion of the investigator that may affect cervical spine function and pain assessments 11. Subjects with a history of cancer must be disease free for at least 3 years; with the exception of squamous cell skin carcinoma 12. Pregnant, or plans on becoming pregnant 13. History of allergy to titanium \-

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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.

Contacts and locations

Locations

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073, United States

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