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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03810573
Ethics application status
Date submitted
17/01/2019
Date registered
18/01/2019
Date last updated
12/03/2024

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
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Removal, revision, or supplemental fixation
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
Sex
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Center - Clayton
Recruitment hospital [2] 0 0
St Vincent Melbourne - Fitzroy
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Kogarah

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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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