Overview

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
Sponsor OhioHealth
Collaborator NuTech Medical, Inc
Start date February 2014
End date February 2017
Trial size 60 participants
Trial identifier NCT02070484, OH2-13-0034

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Stemcell allograft
nucel
(Active Comparator)
DBM bone graft substitute
deminaralized bone matrix

Primary Outcomes

Measure
Oswestry Disability Index
time frame: 12 months

Secondary Outcomes

Measure
Radiological
time frame: 12 months

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by OhioHealth.