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An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation

Intervertebral Disk Degeneration Clinical Trial

Official title:
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation

Clinical Trial Summary

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..

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00310440
Study type Interventional
Source CeraPedics, Inc
Contact
Status Completed
Phase N/A
Start date January 2006
Completion date May 23, 2019
View Details
See also
  Status Clinical Trial Phase
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Completed NCT02425514 - Evaluation of Bone Union Following Anterior Cervical Fusion Using a NovoMax™ N/A
Terminated NCT01326091 - Patient Positioning in Lumbar Fusion Surgery and Its Impact on Spinal Sagittal Balance and Surgeon Satisfaction N/A
Active, not recruiting NCT03214042 - Efficacy and Safety of K-rod Dynamic Stabilization System in the Repair of Lumbar Degenerative Diseases N/A
Terminated NCT02070484 - Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease N/A
Recruiting NCT03343899 - Genotype-related Molecular Targets in the Vitamin D Pathway for Spinal Disc Diseases N/A