Natural Matrix Protein™ (NMP™) in Interbody Lumbar Fusion

NCT05972616 | Completed

• 1 other identifier: SIL-2023-NMP
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the performance of Induce Biologics NMP™ when used to promote interbody fusion for degenerative disease of the lumbar spine.

Conditions

Degenerative Disc Disease

Keywords

lumbar spine fusion

Outcome Measures

Primary Outcomes (1)

• Radiographic fusion rate

  CT scans will be graded from 0 (no boney ingrowth) to 3 (complete bridging) and A (no evidence of supplemental fixation failure) or B (evidence of supplemental fixation failure). Fusion will be defined as a CT grade of 3A with less than 3 degrees of motion at the index level on flexion and extension x-rays.

  12-months post-surgery

Secondary Outcomes (9)

• Change in disability score assessed by Oswestry Disability Index

  Baseline to 12 months post-operative

• Change in disability score assessed by the 12-Item Short Form Survey version 2

  Baseline to 12 months post-operative

• Change in pain score - for the Back

  Baseline to 12 months post-operative

• Change in pain score - for the Left Leg

  Baseline to 12 months post-operative

• Change in pain score - for the Right Leg

  Baseline to 12 months post-operative

Study Arms (1)

NMP

Have clinical or radiological evidence of degenerative disc disease of the lumbar spine. Have been treated with NMP™ during a lumbar spinal fusion procedure.

Biological: Natural Matrix Protein (NMP)

Interventions

Natural Matrix Protein (NMP) BIOLOGICAL

human bone allograft

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 135 patients of the Spine Institute of Louisiana (SIL) who have been treated with Induce Biologics NMP™ during a lumbar interbody fusion. All subjects who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study

You may qualify if:

• Have clinical or radiological evidence of degenerative disc disease of the lumbar spine.
• Have been treated with Induce Biologics NMP™ during a lumbar spinal fusion procedure.
• Be at least 18 years of age.
• Have current contact information.
• Be willing and able to provide written Informed Consent for the prospective part of study participation.
• Be willing and able to undergo a CT-scan and X-rays.
• Be willing and able to complete patient centered outcome questionnaires.

You may not qualify if:

• Currently imprisoned.
• 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.
• X-rays or CT-scan are contraindicated.
• Any previous lumbar fusion or arthroplasty surgery at the index level(s)

Sponsors & Collaborators

• Induce Biologics USA Inc.: lead

Study Sites (1)

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Pierce Nunley, MD

  Spine Institute of Louisiana

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 2, 2023
• Study Start: August 1, 2023
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)