Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03810573

Enrollment

Registered

2019-01-18

Start date

2024-03-01

Completion date

2026-06-01

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disc Disease, Spondylolisthesis

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.

Interventions

DEVICENB1

rhNELL-1/DBX

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

17 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Fusion	12 months	Defined by an independent (blinded to treatment) radiological assessment as less than five degrees angular vertebral motion, less than three millimeters of translational movement and evidence of bridging bone between the involved vertebral endplates based on x-rays at 12 months after surgery

Secondary

Measure	Time frame	Description
Removal, revision, or supplemental fixation	12 months	Whether there was removal, revision or supplemental fixation of the graft material that required reoperation at the index level during the follow-up period of the study

Countries

Australia

Contacts

Primary ContactBrent Atkinson, PhD

atkinsonbrent520@gmail.com13035507866

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026