Assessing Safety of Cervical Spine Fusion With NMP®

Condition(s) studied

Investigational drug(s) / intervention(s)

Natural Matrix Protein (NMP) Fibers: Human bone allograft

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

More Red Rock Regeneration Inc. trials in the USA

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