Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

Bone Biologics

Status: Enrolling

Conditions: Degenerative Disc Disease; Spondylolisthesis

Treatments: Device: NB1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03810573

NB1-100

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 17 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

NB1-1.5

Experimental group

Description:

NB1 low dose

Treatment:

Device: NB1

NB1-2.0

Experimental group

Description:

NB1 high dose

Treatment:

Device: NB1

Autograft

No Intervention group

Description:

Autograft