Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain With or Without Intervertebral Disc Herniation - VAST Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- VIVEX Biologics, Inc.
- Enrollment
- 218
- Locations
- 13
- Primary Endpoint
- Visual Analogue Scale of Pain Intensity (VASPI)
- Last Updated
- 4 years ago
Overview
Brief Summary
The objective of this study is to evaluate the safety and efficacy of viable allograft transplantation for the treatment of patients with symptomatic disc degeneration and tissue loss.
All subjects randomized to Active Allograft will undergo injection of a viable allograft into the nucleus pulposus of the degenerated disc. All subjects randomized to Placebo will undergo injection with saline into the nucleus pulposus of the degenerated disc. All subjects randomized to Conservative Care will continue standard of care, with the opportunity to crossover at 3 months into the Active Allograft arm.
Detailed Description
This is a multicenter, prospective, parallel arm study to assess patients who participated in the VAST trial and receiving either viable allograft, saline, or allograft after cross-over. These patients will be evaluated at baseline, injection, 6 months, and 12 months. Subjects will then have an option for a 24 months and 36 months extension after their index procedures. Patients who received saline or active allograft in the VAST study will be allowed to receive viable allograft and followed for an additional 12 and 24 months after that election. These subjects will need to meet initial inclusion/exclusion criteria again before another injection.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to provide an English written Informed Consent
- •Age 18 to 60 years inclusive
- •Male or female
- •Body mass index \<35
- •Pfirrmann Grade \[3-6\]
- •Radiographic confirmation by MRI/X-ray of:
- •translational instability defined as ≤5 mm, or
- •angular instability defined as ≤5°
- •Back pain (with or without radicular leg pain) measured by:
- •ODI of at least 40%, and
Exclusion Criteria
- •Seropositive or seronegative spondyloarthropathy
- •Type III Modic changes
- •Prior surgeries of segments between L1 and S1
- •Chemonucleolysis or percutaneous laserectomy of the affected disc prior to the study
- •Chronic facet syndrome
- •Stenosis of the spinal canal that is moderate to severe or more in degree
- •Spondylodiscitis
- •Spondylolisthesis (lysis and degenerative)
- •Severe motor deficit or cauda equina disorder based on investigator determination
- •Congenital abnormalities of the spinal nerves
Outcomes
Primary Outcomes
Visual Analogue Scale of Pain Intensity (VASPI)
Time Frame: 36 Months
To evaluate the mean change from 12 months in chronic lumbar back pain scores on the Visual Analogue Scale of Pain Intensity (VASPI) measured from 0mm (no pain) to 100mm (worst pain).
Oswestry Disability Index (ODI)
Time Frame: 36 Months
To evaluate the mean change from 12 months in functional durability on the Oswestry
Secondary Outcomes
- Adverse Events (AEs) and Serious Adverse Events (SAEs)(Through study completion, an average of 12 months)
- MRI Assessments(Baseline, 6 Months, and 12 Months)
- X-Ray Assessments(Baseline, 6 Months, and 12 Months)
- Oswestry Disability Index (ODI)(6 and 12 Months)
- 36-Item Short Form Survey (SF-36) Questionnaire(Baseline, 6 Months, and 12 Months)
- Resource Utilization Questionnaire(Baseline, 6 Months, and 12 Months)