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

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

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).