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 range21 Years
SexALL
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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.
✕. 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.
What they're measuring
1
Interbody Fusion measured using CT scans and standard radiographs