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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03810573




Registration number
NCT03810573
Ethics application status
Date submitted
17/01/2019
Date registered
18/01/2019
Date last updated
18/01/2019

Titles & IDs
Public title
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Scientific 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
Secondary ID [1] 0 0
NB1-100
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative Disc Disease 0 0
Spondylolisthesis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - NB1

Experimental: NB1-1.5 - NB1 low dose

Experimental: NB1-2.0 - NB1 high dose

No Intervention: Autograft - Autograft


Treatment: Devices: NB1
rhNELL-1/DBX

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fusion - 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
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Removal, revision, or supplemental fixation - 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
Timepoint [1] 0 0
12 months

Eligibility
Key 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)
Minimum age
17 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Center - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bone Biologics Corp
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03810573
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tony Goldschlager, MD
Address 0 0
Monash Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Brent Atkinson, PhD
Address 0 0
Country 0 0
Phone 0 0
13035507866
Fax 0 0
Email 0 0
atkinsonbrent520@gmail.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03810573