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

Recruiting at 11 trial locations

Overseen by Michael Janssen, MD / DO

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: CeraPedics, Inc

No Placebo Group

Trial Summary

What is the purpose of this trial?

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..

Research Team

Michael Janssen, MD / DO

Principal Investigator

Spine Education Research Institute

Eligibility Criteria

Inclusion Criteria

Undergoing anterior cervical fusion at a single level

Age between 18 and 65

Radiographically determined discogenic origin to include at least one of the following characteristics: degenerated/dark disc on MRI, decreased disc height compared to adjacent levels on radiographic film, CT, or MRI and disc herniation on CT or MRI

Treatment Details

Interventions

• Autologous bone (Procedure)
• P-15 Synthetic osteoconductive bone substitute (Synthetic Bone Substitute)

Participant Groups

Group I: Bone graft substitute Experimental Treatment 1 Intervention

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

Group II: Autologous Bone Active Control 1 Intervention

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Who Is Running the Clinical Trial?

CeraPedics, Inc

Lead Sponsor

Trials

6

Recruited

1,400+