New titanium cage could improve neck surgery outcomes
NCT ID NCT04214535
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
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2021
- Expected to finish
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Mar 2027
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 years and older
- 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: 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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a common mineral boost the power of Pain-Relieving injections for nerve pain?
- A conversation before spine surgery could change how patients recover
- Can a new bone graft match the gold standard for spinal fusion?
- Mind over neck pain: could mental rehearsal boost physiotherapy?
- Can a nanotube surface help spinal bones fuse faster?