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Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

NCT03810573 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-12

No results posted yet for this study

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.

Conditions

  • Degenerative Disc Disease
  • Spondylolisthesis

Interventions

DEVICE

NB1

rhNELL-1/DBX

Sponsors & Collaborators

  • Bone Biologics Corp

    lead INDUSTRY

Principal Investigators

  • Tony Goldschlager, MD · Monash Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-06-01
Completion
2026-06-01
FDA Device
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03810573 on ClinicalTrials.gov