NCT06000319

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Induce Biologics USA Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study involves a retrospective review of patients' medical records and prospective collection of X-rays, and patient outcome questionnaires. The study population will include 100 consecutive lumbar interbody fusion and 100 consecutive cervical interbody fusion patients who meet the inclusion criteria and do not meet the exclusion criteria. There will be 4 prospective study visits following consent. Follow-up will occur in accordance with standard of care practice and will continue to 12 months post-surgery

Conditions

• Degenerative Disc Disease
• Degenerative Spondylolisthesis
• Spinal Stenosis

Interventions

Type	Name	Description
BIOLOGICAL	Natural Matrix Protein (NMP) Fibers	human bone allograft
PROCEDURE	Lumbar interbody fusion	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.
PROCEDURE	Cervical interbody fusion	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.

Timeline

• Start date: 2024-01-04
• Primary completion: 2027-02-01
• Completion: 2027-08-01
• First posted: 2023-08-21
• Last updated: 2025-11-18

Locations

1 site across 1 country: United States