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Cell Therapy
ViviGen Cellular Bone Matrix for Spondylolisthesis
N/A
Waitlist Available
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months prospective from surgery
Awards & highlights
Summary
This trial is testing ViviGen Cellular Bone Matrix, a special bone graft with living cells, in patients needing spinal fusion in the lower back. ViviGen helps new bone cells grow and form new bone, aiding in the fusion process.
Eligible Conditions
- Spondylolisthesis
- Degenerative Disc Disease
- Spondylosis
- Spinal Stenosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months prospective from surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months prospective from surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Number of Surgical Levels With Successful Lumbar Fusion
Secondary outcome measures
Number of Participants With or Without Changes in Visual Analog Scale Pain Scores
Oswestry Disability Index (ODI) v2.1a
Trial Design
1Treatment groups
Experimental Treatment
Group I: Study ArmExperimental Treatment1 Intervention
Participants will be entered into the single armed study in which one side of the fusion will be coated with milled local autograft bone and the opposite fusion side will be supplemented with an equal volume of Depuy Synthes ViviGen.
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Who is running the clinical trial?
DePuy SynthesIndustry Sponsor
30 Previous Clinical Trials
4,903 Total Patients Enrolled
3 Trials studying Spondylolisthesis
296 Patients Enrolled for Spondylolisthesis
Ohio State UniversityLead Sponsor
844 Previous Clinical Trials
639,488 Total Patients Enrolled
4 Trials studying Spondylolisthesis
310 Patients Enrolled for Spondylolisthesis
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