Actively Recruiting

Phase Not Applicable
Age: 17Years - 70Years
All Genders
NCT03810573

Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

Led by Bone Biologics Corp · Updated on 2024-03-12

30

Participants Needed

3

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

Who Can Participate

Age: 17Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented diagnosis of degenerative disc disease
  • Up to Grade I spondylolisthesis
  • Eligible to undergo a single vertebral level spine fusion (L2 to S1)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Monash Medical Center

Clayton, Victoria, Australia, 3168

Actively Recruiting

2

St Vincent Melbourne

Fitzroy, Australia

Actively Recruiting

3

St George Hospital

Kogarah, Australia

Actively Recruiting

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Research Team

B

Brent Atkinson, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis | DecenTrialz