Assessing Safety of Cervical Spine Fusion With NMP®

NCT ID: NCT07245940

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2026-08-01

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.

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.

Conditions

Degenerative Disc Disease; Degenerative Spondylolisthesis; Spinal Stenosis Cervical

Study Design

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

Study Groups

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

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.

Natural Matrix Protein (NMP) Fibers

Intervention Type: BIOLOGICAL

Human bone allograft

Interventions

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

Natural Matrix Protein (NMP) Fibers

Human bone allograft

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

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

Sponsors

Red Rock Regeneration Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alabama Back Institute

Jasper, Alabama, United States

Countries

United States

Central Contacts

Sean A Peel, PhD

Role: CONTACT

sean.peel@redrockregen.com

416-898-9724

Mark A Prevost II, MD

Role: CONTACT

Other Identifiers

CT-NMP-014

Identifier Type: -

Identifier Source: org_study_id