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

NuTech Medical

Status: Completed

Conditions: Intervertebral Disc Degeneration; Spondylolisthesis; Spinal Stenosis; Spondylosis; Intervertebral Disc Disease

Treatments: Other: NuCel with Autograft

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02023372

RD2013-11-07

Details and patient eligibility

About

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

Full description

The study is a prospective, single center clinical trial to establish the efficacy of NuCel, a minimally manipulated allograft tissue, for use in lumbar interbody and intertransverse fusion procedures. Subjects will undergo standard interbody fusion surgery as per the signed informed consent with NuCel and autograft bone. Patients will be evaluated postoperatively at 6 weeks, 3 months, 6 months, 1 year, and 2 years (if required).

Enrollment: 57 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be diagnosed with degenerative disease of lumbar spine

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

57 participants in 1 patient group

NuCel with Autograft

Other group

Description:

NuCel will be used with local autograft during surgical treatment of one, two or three level degenerative disease of the lumbar spine

Treatment:

Other: NuCel with Autograft