Comparing two types of bone grafts for lumbar fusion surgery
A Prospective, Post-Market, Multicenter Comparative Analysis of the Efficacy of Virtuous and Autograft Bone Graft in Lumbar Fusion Surgery
This study is testing whether a new type of bone graft works better than a traditional one for helping people with degenerative disc disease recover after lumbar fusion surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Orthofix Inc. Industry-sponsored |
| Locations | 1 site (Royal Oak, Michigan) |
| Trial ID | NCT05614284 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of Virtuous bone graft versus autograft in achieving successful lumbar fusion in patients with degenerative disc disease. Participants will undergo transforaminal lumbar interbody fusion (TLIF) using either graft type, with outcomes assessed at 12 and 24 months post-surgery. The study will evaluate both clinical and radiographic results to determine which graft provides better fusion rates. The surgical approach may be minimally invasive or open, adhering to FDA guidelines.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of degenerative disc disease requiring lumbar spine fusion surgery.
Not a fit: Patients who do not have degenerative disc disease or are not candidates for lumbar fusion surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing lumbar fusion surgery.
How similar studies have performed: Other studies have explored various graft options in lumbar fusion, but the specific comparison of Virtuous versus autograft is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Inclusion criteria:
1. At least 18 years of age at the time of surgery
2. Undergoing lumbar spine fusion surgery with one of the following bone grafting options:
1. Virtuous
2. Virtuous with Autograft (local bone)
3. Autograft
4. Autograft + allograft (cancellous bone chips)
3. Subject must have a documented diagnosis of DDD. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings:
1. Instability as defined by \>3mm translation or \>5 degrees angulation
2. Osteophyte formation of facet joints or vertebral endplates
3. Decreased disc height, on average by \>2mm, but dependent upon the spinal level
4. Scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule
5. Herniated nucleus pulposus
6. Facet joint degeneration/changes; and/or
7. Vacuum phenomenon
4. Subject may have up to a Grade I Spondylolisthesis of the lumbar spine with clinical manifestations of one or more of the following phenomena:
1. Radiculopathy
2. Sensory deficit
3. Motor weakness
4. Reflex changes
5. Subject must require lumbar posterolateral arthrodesis at 1-2 contiguous levels (L1-S1).
6. The number of levels decompressed must equal the number of levels fused.
7. Subject must have been unresponsive to conservative care for at least 6 months prior to fusion surgery.
8. Subject must agree not to use electromagnetic adjuncts to enhance bone fusion during the course of the study
9. Subject must be willing and able to sign an informed consent document.
10. Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen.
Exclusion Criteria:
Exclusion criteria:
1. Subject is under 18 years of age (\<18) at the time of consent
2. Subject has had prior lumbar spine fusion surgery at any level
3. Subject has greater than grade 1 spondylolisthesis of the lumbar spine
4. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted)
5. Subject is pregnant (confirmed by pregnancy test) or nursing or planning to become pregnant during the two years (24 months) following arthrodesis
6. Subject has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection
Where this trial is running
Royal Oak, Michigan
- Michigan Brain and Spine — Royal Oak, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Christopher Gunter, MPH
- Email: chrisgunter@orthofix.com
- Phone: 9015962386
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.