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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lumbar Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis, Intervertebral Disk Displacement, Intervertebral Disk Degeneration, Spinal Diseases, Bone Diseases, Musculoskeletal Diseases, Spondylolysis

Intervention / Treatment
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* Biological: NuCel
* Biological: Demineralized Bone Matrix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NuCel<br>Stemcell allograft | Biological: NuCel<br> <br> |
| Active Comparator: Demineralized Bone Matrix (DBM)<br>Demineralized Bone Matrix (DBM) bone graft substitute | Biological: Demineralized Bone Matrix<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | 12 months | 
| Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | Baseline | 
| Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | 1 month | 
| Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | 2 months | 
| Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | 3 months | 
| Oswestry Disability Index | The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion | CT scans reviewed by an independent radiologist and scored according to three categories: no fusion, any fusion, solid fusion. | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NuCel, Lumbar Spine, Degenerative Disease, Efficacy, Fusion