A Prospective Study of NuCel® in Cervical Spine Fusion (NCT02381067) | Clinical Trial Compass
TerminatedNot Applicable
A Prospective Study of NuCel® in Cervical Spine Fusion
Stopped: Departure of PI from the study facility
United States61 participantsStarted 2015-03
Plain-language summary
The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be at least 21 years of age
. Have clinical and radiological evidence of degenerative disc disease, spondylosis, spinal stenosis, or spondylolisthesis at either one, two or three levels of cervical spine.
. In the opinion of the treating surgeon, must already be a qualified candidate for cervical fusion surgery.
. Be likely to return for regular follow-ups until the end of the study period.
. Be willing and able to provide Informed Consent for study participation.
Exclusion criteria
. Neck pain due to acute trauma.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Interbody Fusion measured using CT scans and standard radiographs
. Clinical, laboratory and/or radiological evidence of neck pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.).
. Any terminal or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis.
. Any other concurrent medical disease or treatment that might significantly impair normal healing process as evaluated by the PI.
. Recent history (within past 6 months) of any chemical or alcohol dependence requiring treatment.
. Currently a prisoner.
. Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.