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

Completed · Not applicable

Conditions studied: Intervertebral Disk Degeneration

In brief

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..

Key facts

Study ID

NCT00310440

Run by

CeraPedics, Inc

People needed

319

Starts

2006-01-01

Expected to finish

2019-05-23

Last updated by the study team

2020-03-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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).

Where it is running

• Department of Neurological Surgery UCSF Spine Center — San Francisco, California, United States
• Spine Education Research Institute — Thornton, Colorado, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Orthopaedics Northeast/Midwest Spine Group — Fort Wayne, Indiana, United States
• Indiana Spine Group — Indianapolis, Indiana, United States
• Indianapolis Neurosurgical Group — Indianapolis, Indiana, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• New England Neurosurgical Associates, LLC — Springfield, Massachusetts, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Utah Orthopaedic Center — Salt Lake City, Utah, United States
• Foothills Medical Center — Calgary, Alberta, Canada
• Montreal Neurological Institute — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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