an assessment of p-15 bone putty in anterior cervical fusion with instrumentation

Conditions: Intervertebral Disk Degeneration

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..

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.

Eligibility criteria:
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).

Keywords: degenerative disc disease p-15 bone putty bone graft cervical discectomy cervical spine