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Bone Graft

Virtuos for Degenerative Disc Disease

N/A
Recruiting
Research Sponsored by Orthofix Inc.
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 twelve and twenty-four months
Awards & highlights
No Placebo-Only Group

Summary

This trial compared lumbar fusion rates at 12 and 24 months after surgery using Virtuous or Autograft Bone Graft.

Who is the study for?
This trial is for adults over 18 with Degenerative Disc Disease (DDD) needing lumbar spine fusion surgery at 1-2 levels. They must have tried conservative care for 6+ months without relief, and can't be pregnant or planning pregnancy within two years post-surgery. Prior lumbar fusion or treatment for malignancy in the last five years disqualifies them.
What is being tested?
The study compares the effectiveness of a bone graft material called Virtuos against traditional Autograft Bone Graft in lumbar spine fusion surgeries after 12 and 24 months. The surgical approach includes TLIF with posterior fixation, following FDA guidelines.
What are the potential side effects?
While specific side effects are not listed, typical risks may include pain at the graft site, infection, nerve damage, blood clots, graft rejection or failure to fuse properly which might necessitate additional surgeries.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Successful Fusion
Secondary study objectives
Clinical Outcomes
Safety Profile

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: VirtuousExperimental Treatment1 Intervention
Virtuous +/- Local Bone
Group II: AutograftActive Control1 Intervention
Autograft +/- Allograft Chips

Find a Location

Who is running the clinical trial?

Orthofix Inc.Lead Sponsor
17 Previous Clinical Trials
6,482 Total Patients Enrolled

Media Library

Autograft (Bone Graft) Clinical Trial Eligibility Overview. Trial Name: NCT05614284 — N/A
Degenerative Disc Disease Research Study Groups: Virtuous, Autograft
Degenerative Disc Disease Clinical Trial 2023: Autograft Highlights & Side Effects. Trial Name: NCT05614284 — N/A
Autograft (Bone Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05614284 — N/A
~9 spots leftby Mar 2025
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