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NCT Number: NCT07245940

Assessing Safety of Cervical Spine Fusion With NMP®

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Degenerative Spondylolisthesis Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases Spinal Stenosis Cervical

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alabama Back Institute

Jasper, Alabama, 35501, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Natural Matrix Protein (NMP) Fibers

Biological

Human bone allograft

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.

Primary outcomes

  1. Adverse Event Reporting

    Time frame: 90 days - 24 months postoperatively

    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.

  2. Re-operation Rates

    Time frame: 90 days - 24 months postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark A Prevost II, MD

CONTACT

Sean A Peel, PhD

CONTACT

[email protected]

416-898-9724

Sponsors and collaborators

Lead sponsor

Red Rock Regeneration Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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