NCT00310440

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 319 (actual)
• Sponsor: CeraPedics, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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..

Detailed 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.

Conditions

• Intervertebral Disk Degeneration

Interventions

Type	Name	Description
DEVICE	P-15 Synthetic osteoconductive bone substitute	Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery
OTHER	Autologous bone	Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring

Timeline

• Start date: 2006-01-01
• Primary completion: 2014-05-01
• Completion: 2019-05-23
• First posted: 2006-04-04
• Last updated: 2020-03-12
• Results posted: 2016-02-10

Locations

12 sites across 2 countries: United States, Canada