Assessing Safety of Cervical Spine Fusion With NMP®

Assessing Safety of Cervical Spine Fusion With NMP® Graft Material: A Retrospective Chart Review

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Degenerative Disc Disease; Degenerative Spondylolisthesis; Spinal Stenosis Cervical
• Intervention / Treatment: Procedure: Cervical interbody fusion; Biological: Natural Matrix Protein (NMP) Fibers

Detailed Description

Interbody fusion is a cornerstone of spinal reconstruction, involving placement of a bone graft within the intervertebral space to achieve fusion between adjacent vertebrae. Autogenous bone graft (ABG), typically harvested from the iliac crest, is considered the gold standard due to its osteogenic potential. However, ABG use is limited by donor site morbidity, infection risk, increased operative time, blood loss, and limited graft availability.

Alternative graft materials, such as recombinant human bone morphogenetic protein-2 (rhBMP-2) and demineralized bone matrix (DBM), have been developed to overcome ABG limitations. While rhBMP-2 is highly osteoinductive, off-label cervical use has been associated with severe complications. DBM offers an osteoconductive scaffold but shows variable clinical performance due to inconsistent BMP content.

Cervical spine fusion is a well-established procedure for cervical spine pathologies, but perioperative complications remain significant. Large population-based studies report overall complication rates of 13-14%, with pulmonary events, postoperative hematomas, and dysphagia among the most common. Advanced age and multiple comorbidities are strong predictors of adverse outcomes, with even a single complication prolonging hospitalization and increasing mortality risk.

Given the limitations of current grafts and the high complication rates of cervical spine fusion surgeries, there is a need to evaluate novel biologically active bone grafts. The NMP® bone graft is designed to promote bone formation and may improve safety and clinical outcomes in cervical fusion.

Accurate assessment of adverse events is critical; this study will use the validated SAVES-V2 system to standardize complication reporting, capture severity, and quantify the clinical and economic impact of cervical spine fusion surgery-related adverse events.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Sean A Peel, PhD; Phone Number: 416-898-9724; Email: sean.peel@redrockregen.com
• Study Contact Backup: Name: Mark A Prevost II, MD

Study Locations

• United States
  • Alabama
    • Jasper, Alabama, United States, 35501
      • Alabama Back Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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.; Biological: Natural Matrix Protein (NMP) Fibers; Human bone allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Red Rock Regeneration Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration; N-methylpyrrolidone
• Other Study ID Numbers: CT-NMP-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No