RecruitingNot Applicable

Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

Australia30 participantsStarted 2024-03-01

Plain-language 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.

Who can participate

Age range17 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Fusion

Timeframe: 12 months

Trial details

NCT IDNCT03810573

SponsorBone Biologics Corp

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-01

Contact for this trial

Brent Atkinson, PhD

13035507866 atkinsonbrent520@gmail.com

View on ClinicalTrials.gov More Degenerative Disc Disease trials