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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

Tracking Information
First Submitted Date  ICMJE January 17, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 18, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Degenerative Disc Disease
  • Spondylolisthesis
Intervention  ICMJE Device: NB1
rhNELL-1/DBX
Study Arms  ICMJE
  • Experimental: NB1-1.5
    NB1 low dose
    Intervention: Device: NB1
  • Experimental: NB1-2.0
    NB1 high dose
    Intervention: Device: NB1
  • No Intervention: Autograft
    Autograft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brent Atkinson, PhD 13035507866 atkinsonbrent520@gmail.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810573
Other Study ID Numbers  ICMJE NB1-100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: As requested
Responsible Party Bone Biologics Corp
Study Sponsor  ICMJE Bone Biologics Corp
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tony Goldschlager, MD Monash Health
PRS Account Bone Biologics Corp
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP