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Eligibility
for people ages 18–70
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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..

Details

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.

Keywords

Intervertebral Disk Degeneration Degenerative disc disease P-15 Bone Putty Bone graft Cervical discectomy Cervical spine

Eligibility

You can join if…

Open to people ages 18–70

  • 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
  • Radicular symptoms by history and physical exam to include at least the following characteristics: Arm/shoulder pain, decreased flexes, decreased strength and abnormal sensation
  • Pain level arm/shoulder>4 on 0-10 VAS
  • Pain level neck>4 on 0-10 VAS
  • Neck disability Index>30
  • Involved discs between C3 and C7
  • Undergoing anterior cervical fusion at a single level
  • Failed to gain adequate relief from non-operative treatment
  • Able and willing to give consent to participate in study
  • Understand and read English at elementary level

You CAN'T join if...

Systemic infection such as AIDS, HIV, and active hepatitis; Significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis or osteomalacia; Taking medication for the prevention of osteoporosis; Circulatory, cardiac,or pulmonary problems that could cause excessive surgical risk; Active malignancy;Nondiscogenic source of symptoms (e.g., tumor, etc.); Multiple level symptomatic degenerative disc disease; Previous cervical fusion; Previous cervical decompression at the same level; Acute cervical trauma or instability (i.e., subluxation> 3 mm on flexion/extension radiographic film); Undergoing treatment for tumor or bony traumatic injury to the cervical spine; Rheumatoid disease of the cervical spine; Myelopathy;Pregnant or planning to become pregnant in the next 2 years; Posterior cervical spine procedure scheduled; More than one level to be operated; Has a history of substance abuse(recreational drugs, alcohol); Is a prisoner; Is currently involved in a study of another investigational product for similar purpose; Has a disease process that would preclude accurate evaluation (e.g., neuromuscular disease, significant psychiatric disease).

Locations

  • Todd Lanman, MD, Inc.
    Beverly Hills, California, 90210, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CeraPedics, Inc
ID
NCT00310440
Lead Scientist
Praveen Mummaneni
Study Type
Interventional
Last Updated
January 2016