An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
Intervertebral Disk Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00310440 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- P-15 Synthetic osteoconductive bone substitute (Device); Autologous bone (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CeraPedics, Inc
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiologic Fusion |
129; 121; 16; 20 | — |
| PRIMARY Change in of the Overall Neck Disability Index (NDI) Score From Baseline. |
28.75; 27.40 | — |
| PRIMARY Neurologic Success |
134; 133; 9; 10 | — |
| PRIMARY Complications |
138; 127; 27; 27 | — |
| SECONDARY Mean Change in Pain at Neck Visual Analog Scale (VAS). |
4.45; 4.39 | — |
| SECONDARY Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS). |
4.89; 4.85 | — |
| SECONDARY Success Rates Measured by Aggregated Modified Odom's Criteria |
80; 80; 25; 25; 16; 15 | — |
| SECONDARY Mean Change in the Short Form 36 v2 (SF-36v2) Physical Composite Score (PCS). |
10.02; 9.95 | — |
| SECONDARY Mean Change in the Short Form 36 v2 (SF-36v2) Mental Health Composite Score (MCS). |
8.33; 8.21 | — |
| SECONDARY Kyphosis |
3.0; 3.8 | — |
Summary
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).
Data sourced from ClinicalTrials.gov (NCT00310440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.