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
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 17
Maximum Age: 70
Healthy Volunteers: f
View:

• Documented diagnosis of degenerative disc disease

• Up to Grade I spondylolisthesis

• Eligible to undergo a single vertebral level spine fusion (L2 to S1)

Locations
Other Locations
Australia
Monash Medical Center
RECRUITING
Clayton
St Vincent Melbourne
RECRUITING
Fitzroy
St George Hospital
RECRUITING
Kogarah
Contact Information
Primary
Brent Atkinson, PhD
atkinsonbrent520@gmail.com
13035507866
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 30
Treatments
Experimental: NB1-1.5
NB1 low dose
Experimental: NB1-2.0
NB1 high dose
No_intervention: Autograft
Autograft
Sponsors
Leads: Bone Biologics Corp

This content was sourced from clinicaltrials.gov