Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease
Stopped early · Not applicable
Conditions studied: Lumbar Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis, Intervertebral Disk Displacement, Intervertebral Disk Degeneration, Spinal Diseases, Bone Diseases, Musculoskeletal Diseases, Spondylolysis
In brief
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.
Key facts
- Study ID
- NCT02070484
- Run by
- OhioHealth
- People needed
- 6
- Starts
- 2014-02-01
- Expected to finish
- 2017-03-24
- Last updated by the study team
- 2018-09-28
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Riverside Methodist Hospital — Columbus, Ohio, United States
- Grant Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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