Assessing Safety of Cervical Spine Fusion With NMP®

Red Rock Regeneration Inc.

Status: Not yet enrolling

Conditions: Degenerative Disc Disease; Degenerative Spondylolisthesis; Spinal Stenosis Cervical

Treatments: Biological: Natural Matrix Protein (NMP) Fibers; Procedure: Cervical interbody fusion

Study type: Observational

Funder types: Industry

Identifiers

NCT07245940

CT-NMP-014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Cervical Interbody Fusion with NMP

Description:

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

Treatment:

Procedure: Cervical interbody fusion

Biological: Natural Matrix Protein (NMP) Fibers