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Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

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ClinicalTrials.gov Identifier: NCT03810573
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bone Biologics Corp

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.


Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spondylolisthesis Device: NB1 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: NB1-1.5
NB1 low dose
Device: NB1
rhNELL-1/DBX

Experimental: NB1-2.0
NB1 high dose
Device: NB1
rhNELL-1/DBX

No Intervention: Autograft
Autograft



Primary Outcome Measures :
  1. Fusion [ Time Frame: 12 months ]
    Defined by an independent (blinded to treatment) radiological assessment as less than five degrees angular vertebral motion, less than three millimeters of translational movement and evidence of bridging bone between the involved vertebral endplates based on x-rays at 12 months after surgery


Secondary Outcome Measures :
  1. Removal, revision, or supplemental fixation [ Time Frame: 12 months ]
    Whether there was removal, revision or supplemental fixation of the graft material that required reoperation at the index level during the follow-up period of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810573


Contacts
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Contact: Brent Atkinson, PhD 13035507866 atkinsonbrent520@gmail.com

Locations
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Australia, Victoria
Monash Medical Center Not yet recruiting
Clayton, Victoria, Australia, 3168
Contact: Tony Goldschlager, MD         
Principal Investigator: Tony Goldschlager, MD         
Sponsors and Collaborators
Bone Biologics Corp
Investigators
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Principal Investigator: Tony Goldschlager, MD Monash Health

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Responsible Party: Bone Biologics Corp
ClinicalTrials.gov Identifier: NCT03810573     History of Changes
Other Study ID Numbers: NB1-100
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: As requested

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis