Efficacy Study of NuCel® in Patients Undergoing Fusion of the Lumbar Spine

Completed · Not applicable

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

In brief

The purpose of this study is to determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine.

Key facts

Study ID

NCT02023372

Run by

NuTech Medical, Inc

People needed

57

Starts

2013-12-01

Expected to finish

2019-08-16

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…

• Must be diagnosed with degenerative disease of lumbar spine

You may not qualify if…

• Back pain due to injury
• Back pain that is caused by infection, cancer, lesions(growths) or bone disease such as osteoporosis
• Any terminal (will not recover from the disease) or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis
• Any other medical condition that might affect normal healing
• Less than 21 years of age
• More than three levels of fusion needed
• Recent history (within past 6 months) of any chemical or alcohol dependence
• Morbid obesity (Body Mass Index of more than 40)
• Currently a prisoner
• Currently experiencing a major mental illness
• Pregnancy at the time of enrollment
• Previously diagnosed with diseases of the bone such as osteoporosis, osteopenia or osteomalacia (softening of the bones). Patients with any of the risk factors for osteoporosis may have DEXA scans performed prior to study entry.

Where it is running

• Carolina NeuroSurgery and Spine — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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