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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

Study Summary

This trial is testing a new way to fuse the spine in one or multiple levels. All subjects will be followed for 24 months.

Eligible Conditions
  • Spondylolisthesis
  • Degenerative Disc Disease
  • Spondylosis
  • Spinal Stenosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months prospective from surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months prospective from surgery for reporting.

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.

Find a Location

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
837 Previous Clinical Trials
507,925 Total Patients Enrolled
4 Trials studying Spondylolisthesis
310 Patients Enrolled for Spondylolisthesis
~3 spots leftby Jun 2025
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