NCT03810573 Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
| NCT ID | NCT03810573 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bone Biologics Corp |
| Condition | Degenerative Disc Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-03-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this clinical study is to evaluate the safety and effectiveness of NB1 Bone Graft in subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion. It is estimated that up to 30 participants will be enrolled in approximately 3 clinical sites. During baseline and follow-up assessments, patients will be asked to undergo x-rays and CT scans; adverse events and immunology will be collected, and; participants will be requested to complete participant questionnaires regarding quality of life, pain and function.
Eligibility 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
Contact & Investigator
Jeremy Kam, MD
PRINCIPAL INVESTIGATOR
Monash Health
Frequently Asked Questions
Who can join the NCT03810573 clinical trial?
This trial is open to participants of all sexes, aged 17 Years or older, up to 70 Years, studying Degenerative Disc Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03810573 currently recruiting?
Yes, NCT03810573 is actively recruiting participants. Contact the research team at atkinsonbrent520@gmail.com for enrollment information.
Where is the NCT03810573 trial being conducted?
This trial is being conducted at Clayton, Australia, Fitzroy, Australia.
Who is sponsoring the NCT03810573 clinical trial?
NCT03810573 is sponsored by Bone Biologics Corp. The principal investigator is Jeremy Kam, MD at Monash Health. The trial plans to enroll 30 participants.