A Prospective Study of NuCel® in Cervical Spine Fusion

Stopped early · Not applicable

Conditions studied: Spondylosis, Spinal Stenosis, Spondylolisthesis, Intervertebral Disc Disease, Intervertebral Disc Degeneration

In brief

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.

Key facts

Study ID

NCT02381067

Run by

NuTech Medical, Inc

People needed

61

Starts

2015-03-01

Expected to finish

2016-12-15

Last updated by the study team

2020-01-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Pregnancy at the time of enrollment.
• In order to confirm eligibility, subjects previously diagnosed with osteoporosis, osteopenia or osteomalacia, female subjects over the age of 65, post-menopausal female subjects under the age of 65 with any of the risk factors for osteoporosis, and subjects at the investigator's discretion will have DEXA scans performed prior to study entry. If DEXA is required, exclusion will be defined as a DEXA bone density measurement T score ≤ -2.5

Where it is running

• Wellstar Hospital — Marietta, Georgia, United States

Full record on ClinicalTrials.gov

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