Intervertebral Disk Degeneration Clinical Trial
Official title:
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and fusion (ACDF) with use of a structural allograft ring in patients with degenerative cervical disc disease..
Anterior Cervical Discectomy and Fusion (ACDF) is a common surgical treatment option for
symptomatic degenerative cervical disk disease in patients who fail conservative treatment.
i-FACTOR bone graft is a unique anorganic bone mineral (ABM) and small peptide, P-15™. P-15
is a synthetic fifteen amino acid polypeptide that mimics the cell-binding domain of Type I
human collagen and is responsible for osteogenic cell attachment via alpha2-beta1 integrins.
This is randomized, controlled, multi-center, prospective FDA IDE study conducted to assess
the safety and effectiveness of i-FACTOR bone graft (Cerapedics, Inc. Westminster, CO) in
patients treated with single level ACDF. Patients received i-FACTOR bone graft or local
autologous bone inside a structural allograft.
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