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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ twelve months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~twelve months
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
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Who is running the clinical trial?
Orthofix Inc.Lead Sponsor
16 Previous Clinical Trials
6,332 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a specific spine surgery involving 1-2 backbones.I can attend all follow-up visits and follow the study plan.I am currently receiving treatment for cancer or have recently.I have a mild case of a slipped vertebra.I am having lumbar spine fusion surgery with a specific type of bone graft.I am younger than 18 years old.I am 18 years old or older.I am currently fighting an infection or being treated for one.I have had spine fusion surgery in my lower back.My condition hasn't improved with standard treatments for over 6 months.My lower back has a significant slip between the bones.My diagnosis of DDD is confirmed with specific imaging results.
Research Study Groups:
This trial has the following groups:- Group 1: Virtuous
- Group 2: Autograft
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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