Single-Armed Use of ViviGen Cellular Bone Matrix in Patients Undergoing Posterolateral Lumbar Surgery

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

No Placebo-Only Group

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

Spondylosis
Degenerative Disc Disease
Spondylolisthesis
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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The Number of Surgical Levels With Successful Lumbar Fusion

Secondary study objectives

Number of Participants With or Without Changes in Visual Analog Scale Pain Scores

Oswestry Disability Index (ODI) v2.1a

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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