Evaluating a new bone graft for spine surgery
Official title: A Multi-Center, Prospective, Parallel Group, Randomized, Pilot Study Evaluating Safety And Preliminary Effectiveness Of NB1 Bone Graft In Subjects With Degenerative Disc Disease Undergoing Transforaminal Lumbar Interbody Fusion
Run by Bone Biologics Corp · NCT03810573 · Data updated 2026-11-12
This study is testing a new bone graft to see if it helps people with degenerative disc disease feel better after spine surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 17 Years to 70 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Bone Biologics Corp Industry-sponsored |
| Locations | 2 sites (Clayton, Victoria and 1 other locations) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 1, 2028 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT03810573 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with degenerative disc disease and up to Grade I spondylolisthesis who are eligible for a single vertebral level spine fusion.
✕Probably not a fit
Patients with previous spinal instrumentation, Grade II or greater spondylolisthesis, or infections at the surgery site may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study aims to assess the safety and effectiveness of NB1 Bone Graft in patients with degenerative disc disease who are undergoing transforaminal lumbar interbody fusion. Approximately 30 participants will be enrolled across three clinical sites, where they will undergo x-rays and CT scans during baseline and follow-up assessments. The study will also collect data on adverse events and immunology, as well as patient-reported outcomes related to quality of life, pain, and function.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that enhances recovery and outcomes for patients undergoing spine surgery.
How similar studies have gone: While this approach is being evaluated, similar studies have shown promise in using innovative bone grafts for spinal fusion procedures.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented diagnosis of degenerative disc disease * Up to Grade I spondylolisthesis * Eligible to undergo a single vertebral level spine fusion (L2 to S1) Exclusion Criteria: * Previous spinal instrumentation or previous interbody fusion procedure at the involved level * Grade II or greater spondylolisthesis * Systemic or local infection at the site of surgery
Where it's running
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Monash Medical Center
Clayton, Victoria, Australia Recruiting -
St Vincent Melbourne
Fitzroy, Australia Recruiting
Study contacts
- Principal investigator: Jeremy Kam, MD — Monash Health
- Study coordinator: Brent Atkinson, PhD
- Email: atkinsonbrent520@gmail.com
- Phone: 13035507866
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing two bone grafts for spine surgery outcomes
This study is testing whether two different bone grafts can help patients with spine surgery heal better and achieve solid bone fusion.
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PMCF look at METROSAN spinal systems and BONEGRAFT materials in adults after spine surgery
This PMCF study tests the safety and performance of METROSAN Titania spinal systems and Bonegraft materials in adults undergoing spinal fusion or stabilization in routine practice.
-
Bone marrow concentrate injection added to lumbar microdiscectomy
This trial tests whether adding a bone marrow aspirate concentrate injection during lumbar microdiscectomy helps adults recover better than surgery alone.
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IDCT (Intradiscal Cell Therapy) for single-level mild-to-moderate lumbar degenerative disc disease
This will test whether injecting IDCT (rebonuputemcel) into one degenerating lower-back disc can reduce chronic low back pain in adults with mild-to-moderate lumbar degenerative disc disease.
-
Novosis Putty used with transforaminal lumbar interbody fusion for lumbar degenerative disc disease
The trial will test whether using Novosis Putty during transforaminal lumbar interbody fusion helps adults with lumbar degenerative disc disease heal better compared with standard care.
-
Orthosis and Exercise for Grade 1–2 Spondylolisthesis
This study tests whether stabilization exercise, conventional exercise, or wearing an orthosis can improve pain, physical function, and quality of life in adults with mild spondylolisthesis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.