Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion

Part of paid clinical trials in Jasper, Alabama.

Sponsor
Induce Biologics USA Inc.
Study ID
NCT06000319
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Natural Matrix Protein (NMP) Fibers — BIOLOGICAL
    human bone allograft
  • Lumbar interbody fusion — PROCEDURE
    Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between L1 and S1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.
  • Cervical interbody fusion — PROCEDURE
    Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between C2 and T1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.

Study Details

The aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein™ (NMP™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative disc disease (DDD), spinal stenosis, spondylolisthesis undergoing cervical or lumbar interbody spine fusion at no more than 3 adjacent levels.

Key Dates

Start date
Jan 4, 2024
Status verified
Nov 2025
Primary completion
Feb 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Lumbar Interbody Fusion with NMP
    Subject has undergone lumbar interbody spine fusion at no more than 3 adjacent levels between L1 and S1 where NMP fibers have been used as a bone void filler
  • Arm: Cervical Interbody Fusion with NMP
    Subject has undergone cervical interbody spine fusion at no more than 3 adjacent levels between C2 and T1 where NMP fibers have been used as a bone void filler

Primary Outcome Measure

Incidence of interbody fusion [ Time Frame: Baseline to 12 months post-operative ]

Locations (1)

FacilityCityStateZIPSite coordinators
Alabama Back InstituteJasperAlabama35501-

Find similar trials in Jasper, AL

By research site
Alabama Back Institute· Jasper, AL

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