Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease

N/ATerminatedNCT02070484

OhioHealth6 enrolled

Overview

The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Lumbar Degenerative Disc Disease Spinal Stenosis Spondylolisthesis Spondylosis Intervertebral Disk Displacement Intervertebral Disk Degeneration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Between the ages of 18 and 75 years * Symptomatic, single-level degenerative lumbar disc disease, spondylosis or spondylolisthesis * Failed conservative treatments * Low risk for non-union * Must be candidates for single-level, posteriolateral lumbar spine fusion * Must be able and willing to give Informed Consent * English-speaking Exclusion Criteria: * Smoker (any smoking ≤3 months prior to consent); (Patel et al. 2013) * Patients with poorly controlled diabetes mellitus (HgbA1c \> 7%) * Documented osteoporosis * Prior lumbar spinal surgery at the same spinal level, or immediately adjacent spine level, to the level being operated on * Back pain due to infection, tumour, or metabolic bone disease * Terminal disease, such as HIV infection, neoplasm * Autoimmune disease, such as rheumatoid arthritis * Morbid obesity (body mass index (BMI) of 35 kg/m2) * Major psychiatric illness in the last year * History of alcohol or drug abuse in the last year * Pregnant women

Locations (2)

Riverside Methodist Hospital

Columbus, Ohio, United States

Grant Medical Center

Columbus, Ohio, United States