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

Not Applicable

Completed

• Conditions: Intervertebral Disc Disease; Intervertebral Disc Degeneration; Spondylolisthesis; Spondylosis; Spinal Stenosis
• Interventions: Other: NuCel with Autograft

• Registration Number: NCT02023372
• Lead Sponsor: NuTech Medical, Inc

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Primary Completion: 2019-08-16
• Study Completion: 2019-08-16
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Spinal Fusion	12 months	CT scan will be used to evaluate fusion of one, two, or three levels

Secondary Outcome Measures

Name	Time	Method
Change from baseline pain using Visual Analogue Scale (VAS)	6 weeks, 3 months, 6 months, and 12 months
Change from baseline Oswestry Disability Index (Ver. 2.1)	6 weeks, 3 months, 6 months, 12 months
X-ray to compare to baseline preoperative X-ray	6 weeks, 3 months, 6 months, 12 months

Trial Locations

Locations (1)

Carolina NeuroSurgery and Spine; 🇺🇸 Charlotte, North Carolina, United States