Status:
COMPLETED
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
Lead Sponsor:
CeraPedics, Inc
Conditions:
Intervertebral Disk Degeneration
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 ante...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2019
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT00310440
Start Date
January 1 2006
End Date
May 23 2019
Last Update
March 12 2020
Active Locations (12)
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1
Department of Neurological Surgery UCSF Spine Center
San Francisco, California, United States, 94143
2
Spine Education Research Institute
Thornton, Colorado, United States, 80229
3
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34233
4
Orthopaedics Northeast/Midwest Spine Group
Fort Wayne, Indiana, United States, 46825