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

Efficacy of a Human Amniotic Tissue-derived Allograft, NuCel, in Patients Undergoing Posteriolateral Lumbar Fusions for Degenerative Disc Disease

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.

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