Evaluating a new bone graft for spine surgery
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 17 Years to 70 Years |
| Sex | All |
| Sponsor | Bone Biologics Corp Industry-sponsored |
| Locations | 3 sites (Clayton, Victoria and 2 other locations) |
| Trial ID | NCT03810573 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is being evaluated, similar studies have shown promise in using innovative bone grafts for spinal fusion procedures.
Eligibility criteria
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 this trial is running
Clayton, Victoria and 2 other locations
- Monash Medical Center — Clayton, Victoria, Australia (Recruiting)
- St Vincent Melbourne — Fitzroy, Australia (Recruiting)
- St George Hospital — Kogarah, Australia (Recruiting)
Study contacts
- Principal investigator: Tony Goldschlager, MD — Monash Health
- Study coordinator: Brent Atkinson, PhD
- Email: atkinsonbrent520@gmail.com
- Phone: 13035507866
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.