Efficacy of a Human Amniotic Tissue-derived Allograft, NuCel, in Patients Undergoing Posteriolateral Lumbar Fusions for Degenerative Disc Disease
This trial is active, not recruiting.
|Conditions||lumbar degenerative disc disease, spinal stenosis, spondylolisthesis, spondylosis, intervertebral disk displacement, intervertebral disk degeneration, spinal diseases, bone diseases, musculoskeletal diseases, spondylolysis|
|Treatments||nucel, deminaralized bone matrix|
|Collaborator||NuTech Medical, Inc|
|Start date||February 2014|
|End date||February 2017|
|Trial size||60 participants|
|Trial identifier||NCT02070484, OH2-13-0034|
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.
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
DBM bone graft substitute
Oswestry Disability Index
time frame: 12 months
time frame: 12 months
Male or female participants from 18 years up to 75 years old.
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
|Official title||Efficacy of a Human Amniotic Tissue-derived Allograft, NuCel, in Patients Undergoing Posteriolateral Lumbar Fusions for Degenerative Disc Disease|
|Principal investigator||Joseph Shehadi, MD|
Call for more information