Assessing Safety of Cervical Spine Fusion With NMP®

NCT07245940 | Not Yet Recruiting

• 1 other identifier: CT-NMP-014
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this retrospective chart review study is to assess safety of NMP® in the treatment of cervical spine degenerative conditions by assessing the incidence and nature of AEs in follow-up (minimum of 90 days and up to 2 year post-operatively) as well as reoperation rates.

Conditions

Degenerative Disc Disease; Degenerative Spondylolisthesis; Spinal Stenosis Cervical

Outcome Measures

Primary Outcomes (2)

• Adverse Event Reporting

  assessment of the incidence and nature of AEs. Complications determined to be related to NMP® within at least 3 months post-op will be collected and reported as part of the primary outcome of this study.

  90 days - 24 months postoperatively

• Re-operation Rates

  Re-operation rates determined to be related to NMP® within at least 3 months post-op will be collected and reported as part of the primary outcome of this study.

  90 days - 24 months postoperatively

Study Arms (1)

Cervical Interbody Fusion with NMP

Subject has undergone cervical interbody spine fusion between C2 and T1 where NMP fibers have been used as a bone void filler with minimum of 90-day post-operative follow up data available

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

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 300 patients who have been treated with Induce Biologics NMP™ during cervical 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 4-5 months to complete.

You may qualify if:

• Patients treated with NMP® for Cervical (C2-T1) Interbody fusion (2022-2025) at the study site.
• Minimum of 90-day post-operative follow up data available

You may not qualify if:

• Patients with no follow-up data within 3 months from the surgery date due to missed postoperative appointments.

Sponsors & Collaborators

• Red Rock Regeneration Inc.: lead

Study Sites (1)

Alabama Back Institute

Jasper, Alabama, 35501, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

N-methylpyrrolidone

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Sean A Peel, PhD

CONTACT

416-898-9724; sean.peel@redrockregen.com

Mark A Prevost II, MD

CONTACT

Study Design

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

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)