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

NCT ID: NCT06000319

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-04
• Study Completion Date: 2027-08-01

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Natural Matrix Protein (NMP) Fibers

Intervention Type: BIOLOGICAL

human bone allograft

Lumbar interbody fusion

Intervention Type: 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 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

Natural Matrix Protein (NMP) Fibers

Intervention Type: BIOLOGICAL

human bone allograft

Cervical interbody fusion

Intervention Type: 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.

Interventions

Natural Matrix Protein (NMP) Fibers

human bone allograft

Intervention Type: BIOLOGICAL

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis;

2. 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;

3. Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers;

4. Subject must be 18 years of age or older at the time of consent;

5. Subject must be willing and able to sign an informed consent document;

6. 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.

Exclusion Criteria

1. Subject is under 18 years of age at the time of consent;

2. 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;

3. Subject is currently imprisoned.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Induce Biologics USA Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark A Prevost Sr, MD

Role: PRINCIPAL_INVESTIGATOR

Alabama Back Institute

Mark A Prevost II, MD

Role: PRINCIPAL_INVESTIGATOR

Alabama Back Institute

Locations

Alabama Back Institute

Jasper, Alabama, United States

Countries

United States

Other Identifiers

CT-NMP-001

Identifier Type: -

Identifier Source: org_study_id