Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis Cervical
Conditions
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.
Interventions
BIOLOGICALNatural Matrix Protein (NMP) Fibers
Human bone allograft
PROCEDURECervical 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.
Sponsors
Red Rock Regeneration Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Reporting | 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. |
| Re-operation Rates | 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. |
Countries
United States
Contacts
Primary ContactSean A Peel, PhD
Backup ContactMark A Prevost II, MD
Outcome results
None listed