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

NCT06000319 | Enrolling By Invitation

• 1 other identifier: CT-NMP-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Disc Disease; Degenerative Spondylolisthesis; Spinal Stenosis

Outcome Measures

Primary Outcomes (3)

• Incidence of interbody fusion

  Flexion and Extensions radiographs will be assessed for fusion at each level to be fused Fusion is defined as: (1) less than 5 degrees of motion by flexion extension X-ray and (2) no radiological features of non-union (radiolucency, implant migration, loss of graft height, supplemental fixation failure). Both fusion criteria have to be met to be considered a fusion success at the index level.

  Baseline to 12 months post-operative

• Incidence of secondary surgical intervention

  Secondary surgical interventions (SSI) include revision, re-operation, removal, or supplemental fixation at the index levels

  Baseline to 12 months post-operative

• Incidence of Adverse Product Related Events

  the incidence of the following will be reported: bone resorption with cage migration or subsidence, local inflammation with seromas, ectopic bone formation, radiculitis.

  Baseline to 12 months post-operative

Secondary Outcomes (7)

• Incidence of bridging bone

  Baseline to 12 months post-operative

• Change in disability score for lumbar fusion patients assessed by Oswestry Disability Index

  Baseline to 12 months post-operative

• Change in disability score for cervical fusion patients assessed by Neck Disability Index

  Baseline to 12 months post-operative

• Change in back pain in lumbar fusion patients

  Baseline to 12 months post-operative

• Change in leg pain in lumbar fusion patients

  Baseline to 12 months post-operative

Study Arms (2)

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

Biological: Natural Matrix Protein (NMP) Fibers; Procedure: Lumbar interbody fusion

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

Biological: Natural Matrix Protein (NMP) Fibers; Procedure: Cervical interbody fusion

Interventions

Natural Matrix Protein (NMP) Fibers BIOLOGICAL

human bone allograft

Cervical Interbody Fusion with NMP; Lumbar Interbody Fusion with NMP

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.

Lumbar Interbody Fusion with NMP

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.

Cervical Interbody Fusion with NMP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include up to 200 patients who have been treated with Induce Biologics NMP™ during cervical or lumbar interbody fusion. All subjects who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study. It is expected that enrollment will take 12 months to complete.

You may qualify if:

• Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis;
• Subject has undergone cervical or lumbar interbody spine fusion at no more than 3 adjacent levels between C2 and T1 or between L1 and S1;
• Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers;
• Subject must be 18 years of age or older at the time of consent;
• Subject must be willing and able to sign an informed consent document;
• Subject must be willing and able to return to the study clinic for all follow-up visits, agree to participate in post-operative clinical and radiographic evaluations.

You may not qualify if:

• Subject is under 18 years of age at the time of consent;
• Subject is currently experiencing major mental illness (psychosis, schizophrenia, major affective disorder) which in the opinion of the investigator may indicate that the symptoms are psychological rather than of physical origin;
• Subject is currently imprisoned.

Sponsors & Collaborators

• Induce Biologics USA Inc.: lead

Study Sites (1)

Alabama Back Institute

Jasper, Alabama, 35501, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Stenosis

Interventions

N-methylpyrrolidone

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Mark A Prevost Sr, MD

  Alabama Back Institute

  PRINCIPAL INVESTIGATOR

• Mark A Prevost II, MD

  Alabama Back Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 21, 2023
• Study Start: January 4, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)